INDIAN JOURNAL OF MEDIC AL ETHICS

Vol IX No 1 January-March 2012

(incorporating Issues in Medical Ethics, cumulative Vol XX No 1) www.ijme.in

ISSN 0974 - 8466 (print) ISSN 0975 - 5691 (online)

ENTERING OUR 20TH YEAR

Hunger, ethics and the right to food Impact of disability certificates on privacy and welfare Ambiguities in the Declaration of Helsinki Mainstreaming AYUSH: ethical and governance issues Challenges in the regulation of medical education Film review: 404-Error not found

(incorporating Issues in Medical Ethics, cumulative Vol XX No 1)

INDIAN JOURNAL OF MEDICAL ETHICS VOL IX NO 1 JANUARY-MARCH 2012

Editor Emeritus Sunil K Pandya Editor Amar Jesani Consulting Editor Sandhya Srinivasan Editorial Coordinator Meenakshi DCruz Editorial Board Divya Bhagianadh, Mumbai Mala Ramanathan, Thiruvananthapuram Nobhojit Roy, Mumbai Prabha Chandra, Bangalore Prathap Tharyan, Vellore Sanjay Nagral, Mumbai Sanjay A Pai, Bangalore Editorial Advisory Board Amit Sengupta, Delhi Chhanda Chakraborti, IIT Kharagpur Deepa Venkatachalam, Delhi Dhanwanti Nayak, Manipal G D Ravindran, Bangalore Neha Madhiwalla, Mumbai Parthasarathi Mondal, Mumbai Sridevi Seetharam, Mysore Sujith Chandy, Vellore Suneeta Krishnan, Bangalore Vasantha Muthuswamy, Delhi Vikram Patel, Goa Vinay Chandran, Bangalore International Advisory Board Aamir Jafarey, Pakistan Aasim Ahmad, Pakistan Abha Saxena, Switzerland Aliya Naheed, Bangladesh Angus Dawson, UK Antony Zwi, Australia Anurag Bhargava, Canada Bashir Mamdani, USA Bebe Loff, Australia Fatima Castillo, Phillipines Fiona Miller, Canada Helen Sheehan, USA Jacob Leveridge, UK Julian Sheather, UK Richard Cash, USA Ruth Macklin, USA Sisira Siribaddana, Sri Lanka Solomon Benatar, South Africa Administration and Subscription Santosh Tirlotkar ijmemumbaiATgmail.com Editorial Correspondence Meenakshi DCruz ijme.editorialATgmail.com Subscription Rates
Period

Looking back to move forward

This apparently contradictory step may be inadvisable while crossing the street or driving, but is essential for IJME when entering its 20th year of publication. The same applies to any social organisation or movement, unless it wants to replicate past blunders. India in the 21st century is becoming a battlefield of contradictions: the total population surges ahead while girls are going missing in large numbers; massive stocks of foodgrains rot in the open while people starve without the basic right to food being implemented; and a comprehensive scheme exists for integration of traditional medicine into healthcare, with little practical implementation on the ground. All these gaps have been analysed in this first issue of 2012. Can a research study which aims to reduce suffering caused by a serious health problem be said to be successful if it has exposed participants to unnecessary harm? A study from the 1970s has been revisited and discussed from varied standpoints in this issue, re-examining the ethical standards of healthcare research. Only public probing into the ethical responsibilities of researchers and clinicians, as also researcher-clinicians, can prevent current and future tragedies in the name of public welfare. We also need a medical education system which selects and equips doctors to heal the sick in the best possible way. An editorial and a comment both look into attempts to reform this system. Promising legislations await the attention of parliament in several areas. The draft National Food Security Bill has finally been tabled in the Lok Sabha, the culmination of a long struggle by several organisations. This is the right time to analyse them and press for improvements. We carry an analysis of the new Mental Health Care Bill by a group of practitioners. We have also a strong plea for removal of ambiguity in the Declaration of Helsinki on the existence of placebo-controlled trials so as to make universal standards in healthcare a real possibility. With an issue bursting with energy and ideas, IJME wishes it readers a fruitful and active new year, with the hope that the movement for ethical healthcare and research will stride ahead with increasing confidence.

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The Indian Journal of Medical Ethics (formerly Issues in Medical Ethics) is a platform for discussion on healthcare ethics, with special reference to the problems of developing countries such as India. It hopes to involve all cadres of, and beneficiaries from, this system, and strengthen the hands of those with ethical values and concern for the underprivileged. The Journal is owned and published by the Forum for Medical Ethics Society, a not-for-profit, voluntary organisation. The FMES was born out of an effort by a group of concerned doctors to focus attention on the need for ethical norms and practices in health care. Contributions to the journal, in the form of original papers, research findings, experiences in the field, case studies, debates, news and views on medical ethics, are welcome. All submissions must be in English and are subject to editorial review. Contributors are requested to refer to the detailed guidelines for submission available on the journal website, www.ijme.in
Printed and published by Sanjay Nagral on behalf of the Forum for Medical Ethics Society Printed at Vibha Offset, Royal Industrial Estate, Wadala, Mumbai 400 031 Published at FMES, 0-18, Bhavna, Veer Savarkar Marg Prabhadevi, Mumbai 400 025 Editor: Amar Jesani

Indian Journal of Medical Ethics Vol IX No 1 January - March 2012

Contents

Indian Journal of Medical Ethics

Vol IX No 1, January-March 2012 (incorporating Issues in Medical Ethics, cumulative Vol XX No 1)

EDITORIALS
IJMEs 20th year: some new directions ......................................................................................................................................................... 2 AmAr JesAni The legacy of scandals and non-scandals in research and its lessons for bioethics in India ................................................................. 4 mAlA rAmAnAthAn, AmAr JesAni MCIs VISION 2015 and PG medical selection: continuing to produce square pegs for round holes? ................................................. 7 PrAbhA s ChAndrA, sowmyAshree International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in Paragraph 32 ........ 13 Ay mAlik, F GhAFoor Less equal than others? Experiences of AYUSH medical officers in primary health centres in Andhra Pradesh.............................. 18 Jk lAkshmi Continuing oversight through site monitoring: experiences of an institutional ethics committee .................................................. 22 in an Indian tertiary-care hospital yAshAshri C shetty, PAdmAJA mArAthe, sAndhyA kAmAt, UrmilA thAtte Finding and using evidence that you can trust ....................................................................................................................................... 27 PrAthAP thAryAn Hunger, ethics and the right to food ........................................................................................................................................................ 32 sriJit mishrA Attempts at regulation of medical education by the MCI: issues of unethical and dubious practices .............................................. 37 for compliance by medical colleges and some possible solutions AnAnthAkrishnAn n, shAnthi Ak Disability certificates in India: a challenge to health privacy ................................................................................................................ 43 nn mishrA, ls PArker, Vl nimGAonkAr, sn deshPAnde Ethical aspects of public health legislation: The Mental Health Care Bill, 2011.................................................................................... 46 hArish thiPPeswAmy, kAUsik GoswAmi, sAntosh ChAtUrVedi Observational study of cervical cancer .................................................................................................................................................... 50 From Casebook on ethiCal issues in international health researCh Knowledge vs ethics in clinical research in resource-poor settings: a clinicians perspective ............................................................. 51 b sUbhA sri Lost opportunities ..................................................................................................................................................................................... 53 PriyA sAtAlkAr Observational research where it is most needed .................................................................................................................................... 57 sUJit d rAthod Some ethical issues here: demands of informed consent and ethical justification for research ........................................................ 59 PrAVesh JUnG G William Oslers medical ethics in the 21st-century ................................................................................................................................. 62 riChArd l Golden Back to the future: Towards a critical medical practice............................................................................................................................. 64 dhrUV mAnkAd Medical students as guinea pigs: 404 Error not found ............................................................................................................................. 65 ViVek JAin, rAshmi nAUdiyAl

ARTICLES

COMMENTS

CASE STUDY

CASE STUDY RESPONSES

SELECTED SUMMARY

REVIEWS

FROM THE PRESS ...................................................................................................................................................................................................................................10 FROM OTHER JOURNALS ....................................................................................................................................................................................................................66 LETTERS.................................................................................................................................................................................................................................................... 69 CLINICAL TRIALS WATCH .....................................................................................................................................................................................................................73

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Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

editorials

IJMEs 20th year: some new directions

AMAr JESANI
Trustee, Anusandhan Trust, Sai Ashray, Aaram Society road, Vakola, Santacruz East, Mumbai 400 055 INDIA e-mail: amar.jesani@gmail.com

With this issue of January 2012, the Indian Journal of Medical Ethics (IJME) is entering its 20th year of uninterrupted publication. In the last 19 years, the journal has never had to combine two issues, and has been published regularly in the first month of each quarter. This has been a remarkable feat for a journal on medical ethics and bioethics on a shoestring budget, with voluntary contributions of time and material resources from individuals. IJME has been able to afford some part-time staff support only for the last six years. More heartening than its survival has been the support, goodwill and enduring contribution of its readers and well wishers from India and abroad. Their number is so large that to mention every one of them is impossible. Many may not even like to be named as they have merely done what they considered right and relevant. Their support in the process of growth in quality and content allowed the journal to contribute meaningfully to the debate on improving the health system, medical care and the conduct of health professionals, and in the taking forward and strengthening of bioethics discourse in the country. While the first issue of the journal was published in August 1993, the processes that led to its publication began in 1989, with the coming together of doctors and health activists to intervene in the healthcare system to improve ethical standards, and to bring the concerns of patients, particularly of the most vulnerable segments, to the centre of healthcare. None of these individuals had any formal training or qualifications in bioethics, but they were studying it in their practice, in research and in the discussion of bioethics and the literature. The journal, therefore, became, not just a medium to share views, conclusions and research, but also a platform to learn. Over the years, the sharing and learning aspects of the journal have only been strengthened, and that is what we intend to consolidate. In the beginning, most of us did not harbour any illusion that the journal would be able to carry on for long. In fact, we suffered from insecurity and the fear that it would die in its infancy or in childhood. Its survival and growth was made possible through sustained collective effort. With such support, over the last 19 years, IJME was carefully nurtured by four editors. Its executive editor, who worked with exceptional dedication for 14 years (1998-2011) helped the journal to make the transition from an amateur activity to a professional publication. However, all this was in the spirit of voluntarism, without having any of the administrative and financial support that professionally produced journals normally enjoy. The dedicated efforts of these individuals, with the support of members of the editorial and advisory boards, both national and international, and, indeed, of its writers and readers, have taken IJME from an 8-page newsletter in 1993 to a 64-page, peerreviewed, indexed journal. Increasing numbers of submissions, theme issues and special issues for activities like the National Bioethics Conferences (three so far, in 2005, 2007 and 2010) on the platform of the journal, have often pushed the number of pages to 80 and more than 100. In the year 2000, through voluntary contributions of time and resources by members, the website of the journal was established, scanned copies of past issues were made available, and IJME became an online open-access free journal. At present, the online edition is used substantially by interested readers. In 2010, the journal website received 4.9 million hits, had 330,090 unique visitors with 434,180 visits with over one million pages being viewed and 192 GB volume of material was downloaded.

The transition
The strength of IJME is its organic, gradual growth. It was not something that a commercial publisher with professional, highly paid staff brought forth one fine day for everybody to read and appreciate. It has grown along with the consciousness and commitment to ethics of health professionals and health activists. It has also grown alongside the development of bioethics as a discipline in the country and in the developing world. Perhaps by being both a platform for expressing critical views on ethical issues and a fully peer-reviewed indexed academic journal, it has been a part of bioethics activism as well as of the academic development of bioethics. In that sense, its feet are firmly planted on the reality of the developing world and in movements struggling to improve peoples health and uphold their rights.
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Indian Journal of Medical Ethics Vol IX No 1 January - March 2012

In the future, as the journal builds on this strength, there are some changes in the offing. These changes have been necessitated for various reasons. Given the complexities and demands in terms of time and resources for ensuring effective and efficient peer review of an increasing volume of submissions for publication, copy editing and many other complex components of the production process, it is very difficult for only one or two individuals, despite their dedication, to do everything. We have to gradually put in place a more complex division of labour and adopt the appropriate technology, including an online submission management and production system. While this process started two years ago, we are now required to consolidate it by establishing an independent office of the journal with some full-time support staff, and pay more attention to fund raising. This will mean that some editors and members of the Forum for Medical Ethics (FMES) will have to commit more time to establishing physical structures and work systems for the journal, and also make efforts to raise funds. At the same time, those who have voluntarily shouldered the responsibility of work for the last several years needed a temporary break or respite from the heavy workload they have attended to. This 20th year is, therefore, devoted to such consolidation and transition. We are in the process of establishing an independent office for the journal in Mumbai. In the coming year, we will strive to establish an on-line system for submission, review and production. George Thomas, who has borne the responsibility of editing the journal for the last six years, has stepped down as editor. Sandhya Srinivasan, who has done the back-breaking work of being executive editor for the last 14 years, will continue to provide her expertise and guidance in editing the journal as consulting editor. We are in the process of enlarging the IJME editorial and administrative teams to tackle the new challenges. Two new members have joined the editorial advisory board. We welcome Dhanwanti Nayak, who is an anthropologist with a deep interest in the medical humanities. She teaches at the Manipal Institute of Communication at Manipal University, Karnataka. We also welcome to the board Deepa Venkatachalam. Her key interests are womens health, technologies and bioethics, and she works with the womens group Sama in Delhi. Another new member has joined the international advisory board. We welcome Jacob Leveridge, who is school research facilitator at the University College London, London, UK. We are very happy that these three members have joined us in IJME, and that their support and individual contributions will enrich the journal. During the coming year, we also intend to invite other individuals to be guest editors of our theme-based and special issues, to garner national and international bioethics expertise for the development of the journal. Changes are also occurring in the FMES, the owner and publisher of IJME. This is essential as the FMES, as a non-profit society and public trust, is actually a product of the medical ethics and bioethics movement, and is to some extent shaped by it. In 2011, it invited many individuals from the bioethics movement to be its members, and is thus, involved in a process of transformation from a small, primarily Mumbai-based group to a national level society. In addition, Vasantha Muthuswamy, the distinguished bioethicist, will be taking over as chairperson of the FMES in the latter part of 2012.

The broadening of horizons around bioethics

The primary focus of the journal continues to be medical ethics and bioethics. From within the healthcare system, the ethical concerns and issues of many healthcare professionals, such as nurses and AYUSH professionals, demand attention. In the pluralist healthcare system of India, the quest for healthcare ethics must be enriched and strengthened by including their specific issues and concerns. At the heart of the medical ethics and bioethics movement are the patients, the people, and the more vulnerable they are, the greater the need to be ethical. Normative ethical guidelines, rules and regulations, therefore, find their rationale only in so far as they protect and empower the vulnerable in healthcare relationships. However, as our experiences in India and in many developing countries testify, the mere existence of guidelines and rules and, for that matter, even laws and the power of regulators are not, in themselves, sufficient to improve ethical standards and professional conduct. The high pressure of work in the closed environment of health institutions, the pursuit of excellence in technology instead of humane caring, the high status enjoyed by medical professionals in society, their increasing wealth in the unregulated market of healthcare, etc, have insulated many of them from the living reality of patients and the widening inequities in society. In such a context, those making efforts to achieve an equity-based, humane healthcare system with universal access, are contributing to the strengthening of healthcare ethics. To achieve this, systemic reforms, changes in the conduct of professionals, and greater involvement of patients, and the people in general, in healthcare decision making is necessary. This process could be greatly enriched by interaction with the perspectives of the social sciences, law, philosophy, art, literature, and the media. For the development of holistic and humanistic medicine, it is crucial to open it to public scrutiny and the gaze of other professions. Those perspectives may vary but their interaction with medicine will be mutually beneficial, leading to a better understanding and appreciation of each others contribution. More so for bioethics, as it is multi-disciplinary, with medicine being only one component. Such interactions could contribute positively in the acceptance and observance of ethics by healthcare professionals. They could also act to deepen and widen the processes of building ethical guidelines and rules, which are often dominated by medical professionals. Therefore, IJME will endeavour to expand its scope by including the field of humanities in addressing issues in medical ethics and bioethics. We hope that such an inclusive approach, will, without diluting our focus, enrich the journal as well as the concerns and disciplines it represents.
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Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

The legacy of scandals and non-scandals in research and its lessons for bioethics in India
MALA rAMANATHAN1, AMAr JESANI 2
1 Additional Professor, Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695 011 INDIA e-mail: mala@sctimst.ac.in 2 Trustee, Anusandhan Trust, Sai Ashray, Aaram Society road, Vakola, Santacruz East, Mumbai 400 055 INDIA e-mail: amar.jesani@gmail.com

A case study entitled Observational study of cervical cancer on research undertaken in a south Asian country, published in a , compilation of case studies by Cash and others (1), is the subject of a collection of commentaries in this issue of IJME. The range of responses reflects the commentators individual disciplinary orientations and views on the state of medical practice in those times, and the ethical standards that applied. While reviewing this compilation of case studies, Macklin critiqued the use of historical case studies as they may not resonate with knowledgeable physicians and researchers who would want material that is relevant to their current or future experience (2). Another possible criticism is that case studies based on developed world scenarios may not seem as relevant to researchers from developing countries working within developing world settings. They may respond with What if this happens in our setting? rather than the more evocative There but for the grace of God, go I! which facilitates changes in perceptions and practices.

Bioethics training and international case studies

Indeed, the case studies employed in bioethics training within India, as well as in other parts of the world, are often international research cases from developed countries on issues relevant in their contexts. They may also describe the experiences of researchers from developed countries in the developing countries. As there are very few case studies identifying an Indian location and research sponsored by Indian agencies, trainees from the Indian subcontinent may feel that violations in ethics primarily occur elsewhere, and are perpetrated by others on our people. This belief results in the reiteration of faith in our own morality and ethics, without the realisation that we can learn from such scandals only after in-depth inquiries, research and debate. The history of the Belmont Report is rooted in the inquiry into the Tuskegee study. This report initiated reforms in the way clinical research was conducted in the United States of America. It is also part of the bioethics literature. However, inquiries and scandals that occurred in India are not the subject of bioethics teaching in India. This is not because they do not occur, but because they are not written about, debated or discussed. This shortcoming needs to be corrected and the truth needs to be told as part of the development of the bioethics movement in India. We need to retell history, not as part of a witch hunt to blame or punish those involved, but to teach ourselves and set the record straight, based on the adage: Those who cannot remember the past are condemned to repeat it . The case study presented in this issue had women in different stages of dysplasia who were followed up for an extended period, without treatment; even after evidence for offering such treatment became available. The research was based on the rational assumption that it was important for a country with limited resources for health to determine which of the dysplasias would develop into carcinoma in situ (CIS), thereby identifying the high risk cases who could be given preference in provision of treatment. The study lasted 12 years. This again is reminiscent of the observational study of syphilis in African-American males in Tuskegee, Alabama, USA. In the Tuskegee study syphilis patients had been observed for 40 years, without providing treatment.

research similar to that described in the case study

We know of two research studies conducted in the 1970s and 1980s on carcinoma cervix that are similar to the case study discussed in this issue. One well documented study that was acted upon and followed up was done in New Zealand. The other was carried out in India. The research project that was a matter of public debate in New Zealand was on carcinoma cervix but with slightly different objectives and possible outcomes than the case study published in this issue. This was an observational study on the invasive potentiality of cervical CIS initiated in the mid 1960s at the National Womens Hospital in Auckland; the patients were not offered standard treatment. This study was brought to light in 1987, by two womens health activists and journalists, Sandra Coney and Phillida Bunkle, through an article in New Zealands Auckland-based magazine Metro (3). Following a public outcry, this study became the subject of a judicial enquiry by Judge Silvia Cartwright (4). The public hearings took place between August 1987 and January 1988 and the report was released on August 5, 1988. The findings of this inquiry set the pace for reform in medical research in New Zealand, and the understanding of ethics in health research within the country (5). A system of research ethics committees in which 50% of members came from the lay public was
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Indian Journal of Medical Ethics Vol IX No 1 January - March 2012

established; their functions included the supervision of clinical observational studies. A successful population-based cervical screening programme based on cytological smears began. New Zealand enacted the Code of Patients Rights as a part of the Health and Disability Commissioner Act, 1994. This provided an independent external enforcement system in the Office of the Health and Disability Commissioner (6). Thus, the controversy, the inquiry, and subsequent follow-up created a lasting legacy that enhanced patients rights and reformed medical practice. The research carried out in India, like that in the case study published in this issue, observed women with cervical dysplasia, without offering treatment. It was supported by public funds and carried out by Indian researchers, and it lasted over a decade. The Indian medical and scientific community was aware of the research when it was being carried out. After its completion in 1987, its findings were reported in international journals. At the time it was on in the 1970s and 80s, researchers would have been aware of the international furore generated by the revelations about the Tuskegee trial. When the findings of the Indian study were being published, the controversy regarding the New Zealand study was being reported in the medical literature. Yet, there was no critical reflection within the community of Indian researchers on what was not done; nor were measures taken to provide recompense to the participants in the study. Instead, the country waited long for a public controversy. Ten years after the completion of the study, when some participants started reporting to hospital with cervical cancer, a newspaper report revealed that those participants were the ones who had not been provided treatment during or after the study, nor followed up in the long term (7). The report described it as the use of women as guinea pigs The researchers defended the study by saying that no one . died (8) due to any medical intervention as there was none. However, like any other big scandal on health and research, this one too died down, was soon forgotten, and hardly anything has been written on it since then.

The perils of ignoring history

Among the cancers in India, carcinoma of the cervix is a major killer of women. There is absolutely no doubt that more research for its prevention and treatment is needed in the country. Ours is also a resource-poor setting, and so the argument in justification as given in the case study can be applicable to the research that was done in India. Indeed, the identification of dysplasia that would most likely turn into CIS makes the intervention selective and thus resource saving. In the absence of evidence to the contrary, we may assume that such good intentions motivated the researchers to undertake the study in India. However, a research design based on observing the progression of disease in patients over a period without offering standard treatment during or after the research exposes patients to the risk of suffering from that disease. Such a research design does not offer any benefits to patients who are recruited only for the benefit of science and the benefit of future patients. This produces a serious imbalance in the risk-benefit ratio. This imbalance does not get corrected even when researchers are confident of obtaining written and witnessed informed consent from patients for participation. This inherent imbalance in risks and benefits to participants caused harm to patients; and so the public furore it aroused was fully justified. This situation could have been prevented only by questioning this harmful research design, which could have forced the researchers to look for alternative research designs to generate the kind of evidence they needed. It has been argued that research of the kind described in the case study was essential for making treatment available to those who needed it the most. However, the government, which sponsored the research, did not follow this up with a genuine implementation of the universal cervical screening programme. Even a quarter century after the completion of the research, and 15 years after the reporting of the ethics controversy in the media, the universalisation of cervical screening with the provision of treatment to those who need it the most remains a distant dream. If the research is described as sacrificing a few now in order to save many millions later an argument deeply problematic in ethics and indeed unacceptable in this case sacrifice did not usher in the provision of real care for all women who needed it, though some did benefit from it. Unethical research, even when it is on correctly identified health problems and produces useful outcomes, not only poses potentially serious harm to the participants, but also sometimes affects the priority accorded to these health problems. When a few scientists and physicians show lack of respect for vulnerable participants, future potential participants and society in general become suspicious of the motives and credibility of all researchers. Therefore, a short-lived media controversy on such research is not sufficient to correct the situation. What is needed is efficient and transparent investigation of such cases to bring out the facts in public, making those responsible for violations accountable. Further there is a need to use the findings of these inquires to improve the governance of research and ethics education of all stakeholders. Apparently, nothing of the sort that New Zealand did was done in India. And despite the numerous other controversies in biomedical research after this study more so after 2005 when corporate- sponsored clinical trials increased in number the governance of research and ethics education remain abysmal in India. We have recently witnessed another controversy about ethics violations arising out of research into carcinoma of the cervix. This relates to the manner in which the phase IV clinical trials and demonstration project on HPV vaccines used for the prevention of carcinoma of the cervix were conducted. The public outcry surrounding it resulted in the suspension of the project and institution of an inquiry to investigate ethics violations and the deaths of participants. Of course, the institution of an inquiry is a step forward
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Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

when compared with the handling of the earlier controversy on the research into this disease. However, the report of the inquiry has still not been made public, though it was formally submitted to government by the committee. The facts of that research still remain disputed due to such secrecy; nobody is held accountable for violations, and of course no learning for researchers emerges from even such a controversial case (9).

Learning from history and ethics cases

On October 1, 2010, the United States secretary of state, Hilary Clinton, and the health and human services secretary, Kathleen Sebelius, expressed regret and tendered their apologies to Guatemalans who were harmed by the US Public Health Service sexually transmitted disease inoculation study of 1946-1948 (10). This was an outcome of painstaking research on the subject done by a historian, Susan Reverby, which exposed the deliberate inoculation of infective agents into many Guatemalan people as a part of a research project sponsored by US government agencies (11). One may say that an apology is insufficient to provide solace to those who suffered, and to bring back respect to the community and the country. But an admission of error, and the reaching out to those who suffered and their community, is a good beginning. One will want such apologies in all cases where nations have violated ethics in research. However, ethical practices and review in research, and the ability to learn from past mistakes, cannot be limited to a first world initiative, when the potential for unethical practices is universal. If we do not dust off old books on our own medical research, identify lapses, document them and discuss them, we will fail the stakeholders of such research those who will participate either as subjects or as researchers in future initiatives or as regulators of such research in India. It is for this reason that we decided to publicise this case study and initiate discussion on it-- many decades after the event -- to obtain a better understanding of the need for ethics in research, and to facilitate an understanding of the issues among future researchers within the country. A case study of the kind published in this journal may not be sufficient to go into all the issues in the actual research, but it should be a sufficient trigger for historians to re-examine these concerns.
References 1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research [Internet]. Geneva:World Health Organisation;2009 [cited 2011 Dec 13];124-5. Available from: http://whqlibdoc.who.int/publications/2009/9789241547727_eng.pdf 2. Macklin R. Casebook on ethical issues in international health research. Bull World Health Organ [Internet]. 2010 [cited 2011 Dec 13];88:716. Available from: http://www.who.int/bulletin/volumes/88/9/10-078469/en/index.html 3. Rosier P. The speculum bites back: feminists spark an inquiry into the treatment of carcinoma in Situ at Aucklands National Womens Hospital. Reprod Genet Eng [Internet].1989[cited 2011 Dec 13];2(2):121-32. Available from: http://www.finrrage.org/pdf_files/RepTech%20General/Carcinoma_In_Situ. pdf 4. Cartwright S. The report of the committee of inquiry into allegations concerning the treatment of cervical cancer at National Womens hospital and into other related matters [Internet]. Auckland (New Zealand): Government Printing Office, Auckland; 1988 Aug 5[cited 2011 Dec 13]. 288p. Report No.:ISBN0-47300664-2. Available from: http://www.nsu.govt.nz/Current-NSU-Programmes/3233.aspx 5. Paterson R. The Cartwright legacy: shifting the focus of attention from the doctor to the patient. N Z Med J [Internet]. 2010 Jul 30 [cited 2011 Dec 13];123(1319):6-10. Available from: journal.nzma.org.nz/journal/123-1319/4239 6. Bunkle P. Patient-centred ethics, the Cartwright Inquiry and feminism: identifying the central fallacy in Linda Bryder, A history of theunfortunate experiment at National Womens Hospital (2009, 2010). Womens Studies Journal [Internet]. 2010[cited 2011 Dec 13];24(2):8-24. Available from: http://www. wsanz.org.nz/journal/docs/WSJNZ242Bunkle8-24.pdf 7. Mudur GS. ICMR let women guinea pigs get cancer. The Telegraph (New Delhi Ed). 1997 Mar 22. 8. Mudur GS. Gynaecologists refuse to buy no one died argument: Cancer trial stroke ethics debate. The Telegraph (New Delhi Ed). 1997 Mar 23. 9. Sarojini N, Shenoi A, Srinivasan S, Jesani A. Undeniable violations and unidentifiable violators. Econ Pol Wkly. 2011 Jun 11;46(24):17-9. 10. US Department of Health and Human Services [Internet].Washington DC: US Department of Health and Human Services. Joint Statement by Secretaries Clinton and Sebelius on a 1946-1948 study; 2010 Oct 1[cited 2011 Dec 13];[about 2 screens]. Available from: http://www.hhs.gov/news/press/2010pres/ 10/20101001a.html 11. Reverby SM. Normal exposure and inoculation syphilis: a PHS Tuskegee doctor in Guatemala, 1946-1948. J Policy Hist. 2011;23(1):6-28.

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MCIs VISION 2015 and PG medical selection: continuing to produce square pegs for round holes?
PrABHA S CHANDrA1, SOWMYASHrEE2
1 Professor of Psychiatry, 2 PhD student, Neurosciences, National Institute of Mental Health and Neurosciences, Bangalore 560 029 INDIA Author for correspondence: Prabha S Chandra e-mail: prabhasch@gmail.com

The need for better methods of selection for postgraduate (PG) medical seats in different specialties has never been more keenly felt than in the current scenario. Multiple entrance exams, management quota and paid seats, the urgency to get into a PG seat at any cost and the mushrooming of PG entrance exam coaching centres have added to the angst and woes of medical students. Currently the Indian medical education system is one of the largest in the world with around 250 colleges fully recognised by the Medical Council of India (MCI). The increasing demand for doctors trained in basic skills and the need to maintain the educational system on par with global standards is quite challenging, considering all the hurdles which come in the way of improving quality. One author of this editorial is a postgraduate teacher who has been involved in PG entrance examinations for several years and the other a medical student who has appeared for 30 entrance exams in the last two years! We have also taken the opinions of several students who have either got or not got a PG medical seat after going through several entrance exams across the country. Based on this, we speculate on the problems of the current system, review the VISION 2015 proposed by the Medical Council of India (MCI) to see if it improves the situation, and suggest some alternative strategies based on a review of literature on advanced and superior methods of selection in some other countries (1). Regarding the paper pattern for entrance exams, the current preference for multiple choice questions (MCQs) as a method of selection was initiated to enhance objectivity. However, even as late as the 1980s and 90s, many institutions had recognised the need for getting to know the candidate either through an interview or through a brief clinical assessment. If candidates had qualified in the theory entrance exam, they had to undergo a face to face interview or some form of clinical assessment in several institutions. The suitability and aptitude of the candidate for the particular specialty would be discussed before the actual selection. While not being entirely fool proof, it was probably more gratifying for the selection panel and the student and resulted in a better fit. However, all these initiatives had to be abandoned in the name of objectivity and the use of only the MCQ test was proposed by the MCI as the preferred method. An ability to solve MCQs, however, does not reflect the abilities of a good doctor. Unfortunately, what was considered as the best method has now resulted in a bit of a Frankenstein-like situation. Students start worrying about a PG seat in the final year of medicine, and the internship is spent not in gaining clinical skills but in preparing for the entrance examinations. There are many students who, by their own admission, have not touched a patient during their internship, nor written a single prescription.

Objectivity -- but at what cost?

The scope of the PG centralised entrance test (CET), as it is conducted today, does not include assessment for aptitude in the specialty desired by the candidate. Hence, students tend to neglect their undergraduate education and concentrate on the CET. The only deciding factor is the marks obtained in the CET, with the entrant accepting the subject available to her, not necessarily the subject she has an aptitude for, or the one she likes. As a result, many students drop out of courses that they join and several continue half-heartedly. All manner of scams are being revealed because of this method, including impersonation, students with high marks giving up their seats for a price, and of course much money changing hands. This is unheard of in most developed countries. Pursuing a medical specialty should be a calling and not a financial deal, and the consequence should not be the demoralisation of the medical student community.

Is there an alternative?
Several options exist and we have models from several countries which we can emulate. One possibility is to use marks obtained in the MBBS exams. Since it would be difficult to assess in depth the expertise of the student in the desired subject, it would be useful to consider the marks obtained by the student in that subject at the university examination. Monitoring the growth in knowledge of students indicates the contributions made by the different training phases (2). An aptitude test would also be useful, because that would match students to courses that require special skills, such as surgical courses, or those that require an abiding interest and aptitude, such as psychiatry (3).
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VISION 2015 does it provide any solutions?

The VISION 2015 document of the MCI suggests having an entrance examination soon after the final MBBS examination and just before internship. This has been proposed so that students are not preoccupied by the entrance exams during internship, and focus more on clinical skills (1). Several students we spoke to felt that the new policy of having an exam after the final MBBS will only add to the students burden, as the exam is in an MCQ pattern while the final MBBS exam is in a different format. They felt that two months of preparation time would be insufficient and, in the process, students might neglect the final MBBS exam and, in turn, perform poorly at both exams. Most students we spoke to, including the second author of this paper, had written an average of 30 entrance exams in a span of two years before getting admission into a PG course. In their experience, preparation to answer MCQs is completely different from that for a theory paper. It is an interesting observation because it gives us some idea that MCQs may not actually be testing the three attributes that they should be: knowledge, skills and aptitude of the doctor. Instead they seem to test the ability to think in a multiple choice format. VISION 2015 also states that, at the end of internship, the licentiate examination would assess skills. A laudable goal indeed and much needed. However, this may not solve all the problems. It is not yet clear if this would happen as a common exam or would be assessed at the level of individual medical colleges. What of students who did not qualify for PG seats before internship? What if students who feel they are not completely prepared for entrance exams take a year off before exams for studies? These situations may again lead to a waste of resources, with the hospitals lacking interns and patient care being affected. VISION 2015 is silent about assessing aptitude, matching courses to candidates and also about enhancing objectivity in assessment by methods other than the MCQ format of entrance examinations. There is also a lack of recognition of the postgraduate as a professional and a leader, and a focus only on technical knowledge. Ideally, students who have some leadership experience and those who have participated regularly in social/community health outreach programmes should receive extra credit in selection criteria. This will bring recognition to non-academic activities, which positively hone the personality and outlook of a doctor and are as important as knowledge. Research experience, conference presentations and/or publications in journals should also provide bonus points to PG examination candidates. This will help encourage more medical student involvement in research activities (4, 5). Rural work experience for a minimum number of years after completion of the MBBS is already being used as a criterion by some state governments for providing priority in PG course admissions. This is one way of encouraging fresh doctors to spend some time serving in underprivileged rural areas. VISION 2015 addresses various reforms which have to be implemented to improve the existing educational system. However, the students we spoke to felt that it would only minimally help in decreasing the existing burden on students in the race to get a PG seat. More exams would only mean more stress. The idea of having a new pattern of examinations with clinical questions is encouraging. However, we strongly feel that more evidence is needed regarding the nature of questions and responses that actually tap knowledge and skills. Even though hundreds of PG entrance exams have been conducted over the last several years, there is no database or research to guide examiners who set questions for these exams. Which questions appear to be the more discerning, what is the distribution of the nature of questions, what should be the right proportion of clinical versus theoretical questions and should all the questions simply be in the `one of four choices format, or will any other format of MCQ work better? It is time that the MCI actually looked at some of these issues and gathered evidence to guide future examiners. Examinations at this level need to focus on an in-depth assessment of the students knowledge and competency. Questions with multiple responses (with the possibility of more than one answer being correct) are much better than single correct response MCQs in this regard (5). When a candidate attempts such a question with multiple answer options, it tests her in-depth knowledge, observation skills and efficiency in time management. It often simulates a clinical situation where patients might present with comorbid conditions or multiple symptoms and signs relating to a medical condition. Students also felt that the newer changed terms in the VISION 2015, for various courses will not help to improve the quality of education. The proposed framework suggests introduction of a two year Master of Medicine (M Med) programme as the first level of specialisation with the focus on skill development and providing care to the community. These PG students will be trained mainly to enhance clinical skills rather than being engaged in basic research. A second exam after M Med will select students for an MD/MS. This would be a burden for students and many M Med students may again neglect learning skills in the process of trying to get a good score for an MD/MS seat. Another issue not clearly addressed is whether M Med is like a diploma course in a particular specialty, or a general training course in basic skills. If students have to prepare for another common exit exam after M Med, they will have no time to learn anything in a particular specialty in a period of one year after M.Med. Some of them might spend more than a year preparing for the PG entrance exam again. Some questions, which are not addressed by the VISION 2015, but are important in the lives of medical students we interviewed included:
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l Would entry to all seats come through the common entrance test? l Would there be reservations for seats as in the current selection pattern? l What is the pattern of counselling? l What would the fee structure be? Would each states fee structure be different? l Will the current management quota for seats in private colleges continue? l What about the private deemed universities and their seats? l What if some states do not want to be bound by the common entrance exam? l How will transparency be monitored?

Well-planned methods of selection in other countries

Most other countries with well-planned postgraduate or residency programmes focus on the assessment of clinical skills and aptitude in addition to an MCQ paper for theory. Several centres in the United States have one exam related to clinical skills. Here, they video record the whole exam session and assess the student for all aspects of patient care -- history taking and examination, arriving at a diagnosis, explaining the prognosis and also prescribing treatment. The US is also planning to introduce new guidelines and more marks for communication skills from 2012. Students write letters to their universities of interest and once they get good percentile marks in the first and second steps of the medical licensing examination, they have interviews with deans of the various universities or the experts in the field. They are also required to send a letter of recommendation from doctors with whom they have previously worked. This process, which is called `matching, is a good practice because candidates get to choose the subject of specialisation and also the university where they want to study, and the universities are allowed to choose the students who they feel will fit in with their system. In some other countries, while there is no separate live assessment of clinical skills, there is an exam which includes interpretation of videos, data tables, pathological slides and other investigations. This is a particularly good method for assessing aptitude and if one uses the objective structured clinical examination format this can be objective. However, this will require much thought, planning and training of large numbers of examiners across the country and some form of standardisation. It is sad to see the medical graduates plight, following soon after a rigorous course like MBBS. The anxiety of getting a PG seat and the inadequacies in the process of selection are a daunting combination. It is customary in many decision-making bodies the world over to have consumers as part of the process. Maybe it is time to have students and junior faculty as part of the VISION 2015 committee, to give an insiders view about what is actually happening in the field. This may help the potential PG student and bring about more modern and evidence-based methods of selection.
References 1. Medical Council of India. VISION 2015 [Internet]. New Delhi:2011 Mar [cited 2011 Dec 1]; Available from: www.mciindiia.org 2. van Leeuwen YD, Mol SS, Pollemans MC, van der Vleuten CP, Grol R, Drop MJ. Selection for postgraduate training for general practice: the role of knowledge tests. Br J Gen Pract. 1997 June;47(419):35962. 3. Parulekar SV. Postgraduate entrance test reforms. J Postgrad Med. 2011;57:263-4. 4. Bhan A. Conduct of postgraduate medical entrance examinations: Amendments needed. J Postgrad Med. 2010;56:332-3. 5. Iyer DS, Bhan A. Postgraduate medical entrance system needs reforms. Natl Med J India. 2009 May-Jun;22(3):162-3.

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FroM tHe Press

Horror in hospital
In a shocking tale of medical negligence, a 28-year-old woman suffered burn injuries after being cleaned with a toxic chemical following her delivery. The incident occurred at Lalbag sub-divisional hospital in Murshidabad district of West Bengal on November 1, 2011 after the woman, Sikha Biwi, apparently delivered a dead child. Initially it was suspected that carbolic acid was used to rub her clean. Deputy chief medical officer health Birendra Kumar Show issued a statement: It was not done intentionally. The attendants washed the patient with the acid by mistake. The colour of the acid and the anti-infectant is almost similar. The bottles somehow got mixed. A sweeper must have kept the bottle of the acid there. It now seems that the liquid may not have been acid but some other toxic chemical. Even as the hospital claimed that the child was born dead; allegations that the baby boy died due to the toxicity of the chemical have forced the Lalbag sub-divisional officer to probe further into the matter. Meanwhile, West Bengal continues to hog the news for the highest number of reported infant deaths in its state-run hospitals. In a re-run of the July 2011 incident when 21 babies died in three days at the B C Roy Hospital, Kolkata, 45 babies died in one week at two state-run hospitals in Kolkata and Burdwan from October 25 to 28, 2011. While 16 babies died at the BC Roy Childrens Hospital, the Burdwan Medical College and Hospital reported 12 infant deaths. Giving the hospitals a clean chit, the Minister of State for Health, Sudip Bandopadhyay, said, Ive totally given them a clean chit because I believe that this is not due to negligence of the authorities . . . . Infant mortality rate in West Bengal is 33 per thousand live births which is much better than other states. Hospital authorities too maintain that there is nothing abnormal or unusual in the deaths because the babies, they claim, were brought in in an extremely critical condition. from: http://news.in.msn.com/national/article.aspx?cpdocumentid=5563140. The Times of India, November 3, 2011. Available from: http://timesofindia.indiatimes. co m / c i t y / ko l k at a - / Tox i c - w a s h - N u r s e - s u s p e n d e d / articleshow/10600340.cms. Indo Asian News Service, Six more babies die in Bengal Hospital, NDTV, November 11, 2011. Available from: http://www.ndtv.com/article/india/ six-more-babies-die-in-bengal-hospital-148773

Gujarats polluted fields

In some villages of Gujarat, borewells spew reddish brown water. Irrigated fields are contaminated with industrial effluents. Yet, say the villagers, the authorities have failed to bring to book those responsible for this situation. Residents of Nodhana in Bharuch district complain that seepage from a nearby effluent channel has been contaminating their fields for the last two decades. The Mukteshwar Mahadev Temple lake in Bharuch district has turned violet. 46 industries, mainly manufacturing chemicals and dyes, in Bharuch and Vadodara districts, release treated effluent into the channel. Residents claim that a number of these industries discharge untreated or partially treated wastewaters into the effluent channel. The channel was built by Effluent Channel Project Limited (ECPL) in 1983 to carry treated effluent to the Gulf of Khambhat. Currently, it is said to discharge 300 million litres of effluent treated at a common plant, every day into the Gulf. Following complaints from the villagers, the ECPL was reduced from 55 km to 46.5 km in 2004 and the route of the remaining part of the channel passing through Nodhana was diverted using an underground PVC pipeline. In May 2011, following a complaint from Nodhana panchayat that the pipeline had put irrigated fields and water sources at risk, the Bharuch district administration, along with the Gujarat Pollution Control Board, sent a notice to ECPL. ECPL, on the other hand, denies receiving any such notice.

Luna, a village situated along the 55 km long effluent channel, However, underlining the poor health infrastructure in the State once known as the vegetable basket of western India, tells a once again, six more babies died in a Malda district hospital similar story. The residents of the village and its surrounding areas in Padra taluk, Vadodara district, claim that their borewells between November 9 and 10, 2011. are not just contaminated but also filled with industrial While probes are routinely ordered, the government is busy effluents. Luna, in fact, faces pollution not only from the channel defending the hospital authorities, amidst the rising public but also from the industries located nearby. In May 2011, the frustration at medical negligence. Central Pollution Control Board tested the groundwater and surface water in the region and found that of the 108 borewells, NDTV Correspondent, 45 infant deaths in one week in as many as 45 were contaminated by effluents comprising lead, West Bengal, Mamata silent NDTV, November 1, 2011. mercury and ammoniacal nitrogen. Available from: http://www.ndtv.com/article/india/45infant-deaths-in-one-week-in-west-bengal-mamata- However, according to the local administration in both the silent-145579&cp. PTI, Nurses clean woman with acid districts, a survey on the health effects of the contamination is after childbirth, msn News, November 2, 2011. Available still pending.
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Anupam Chakravartty, Stinking for two decades, Down to Earth, November 30, 2011. Available from: http://www. downtoearth.org.in/content/stinking-two-decades. Anupam Chakravartty, Polluters get away by making ad hoc payments to farmers. Down to Earth, November 29, 2011. Available from: http://www.downtoearth.org.in/content/ polluters-get-away-making-ad-hoc-payment-farmers

complications, the FDA said, thus opening up debates about newer contraceptives available for women. Jef Feeley and Margaret Cronin Fisk, Bayer may have pitched birth control pill for unapproved use, Bloomberg, November 22, 2011. Available from: http://www.bloomberg. com/news/2011-11-21/bayer-may-have-touted-birthcontrol-pills-for-unapproved-use-e-mails-show.html. Tracy Staton, FDA study: newer contraceptives carry higher risks, Fierce Pharma, October 28, 2011. Available from: http://www.fiercepharma.com/story/fda-study-newercontraceptives-carry-higher-risks/2011-10-28

Pill of contention
Yasmin and Yaz, Bayer Pharmaceutical Companys popular oral contraceptives, also prescribed in India, are fast gathering lawsuits in the West. Several women have taken the company to court for misleading them about the health risks posed by the pills. While Yasmin has been available in the US market since 2004, Yaz, a spin-off of Yasmin, was approved by the US Food and Drug Administration (FDA) in 2006. Research on the pills has reportedly revealed that women consuming them are prone to blood clots, heart attacks and strokes. Bayer faces more than 10,000 lawsuits over problems allegedly caused by these pills. The latest in the string of accusations against Bayer is that it may have pitched the Yasmin family of birth-control pills for unapproved use. According to company emails that were made public following litigation, Bayer officials had discussed how to promote Yaz as a treatment for all kinds of premenstrual syndromes (PMS) not just for premenstrual dysphoric disorder, for which regulators had approved it. Apparently Bayer officials sent emails to their sales people in 2006 saying that they should cite a Womens Day magazine article which said that Yaz was a safe PMS treatment. According to the copy of the email produced, Matt Sample, a Bayer unit sales consultant wrote, This article is a nice way of using Yaz for PMS treatment instead of just focusing on the specific class of women struggling against the most severe form of PMS, that is. Besides the off-label marketing allegations, lawyers representing women suing Bayer have alleged that company officials withheld information from patients, doctors and regulators about the drugs risk of causing blood-clots in their rush for profit. Apparently, Bayers contraceptives generated $ 1.58 billion in sales last year, making them the companys biggest-selling drugs after Betaseron, a multiple sclerosis medication. An FDA study reveals that contraceptives that contain a particular synthetic hormone called drospirenone carry higherthan-previously-thought-of risks of blood clots. Drospirenone is an active ingredient in Bayers line of products. A study of 1.3 million Danish women revealed that pills containing drospirenone were linked to a six-fold increase in dangerous blood clots. In a review of 800,000 American womens medical histories, the FDA found that women using Yaz had significantly higher rates of blood clots than women using the older pills. However, women using Johnson & Johnsons patch, Ortho Evra, and Mercks NuvaRing also experienced a higher rate of

Nursing their discontent

Around 250 nurses of the Asian Heart Hospital and neighbouring hospitals in Mumbai went on strike on October 19, following the suicide of a 22-year-old nurse, Beena Bebi, of the same hospital. Beena was said to have been driven to suicide following harassment after she misplaced a patients ultrasound report. However, the tragedy set off a wave of frustration among the nursing staff on issues such as a twoyear bond they were compelled to sign, the confiscation of their original certificates, and the condition that they pay Rs 50,000 in case they wished to leave their jobs at the hospital before completing two years of service. They also complained of abusive treatment from their seniors at work. During the strike period the nurses were lathi-charged by the police and 20 on-call nurses were evicted from their residential quarters at the hospital. As the majority of nurses were from Kerala, two Members of Parliament from that state visited Mumbai in an attempt to intervene and settle the dispute. They also wanted the management to take responsibility for Beenas death and send her body to her home in Kerala for the last rites. Ultimately, the strike was called off after four days, with some demands being granted: the revocation of the two-year bond and work experience certificates to those with less than two years service. These certificates had earlier been given only to those with more than two years of service at the hospital. However, the nurses are said to have had to undergo interviews and sign fresh contracts at the end of the strike, as also pay a deposit of Rs 10,000. This was to be further supplemented by Rs 1,000 being cut from their salaries every month, the whole amount being forfeit in case they gave up their jobs in less than two years. The strike brought out the simmering resentment among the nursing cadre in even the more reputed private hospitals in the city. DNA correspondent, Mumbais Asian Heart Hospital nurse commits suicide; others strike work, DNA October 19, 2011. Available from: http://www.dnaindia.com/mumbai/ report_mumbai-s-asian-heart-hospital-nurse-commitssuicide-others-strike-work_1600768 HT Correspondent, Asian Heart Hospital nurses call off four-day-long strike, Hindustan Times, October 23, 2011. Available from: http:// www.hindustantimes.com/India-news/Mumbai/AsianHeart-Hospital-nurses-call-off-four-day-long-strike/ Article1-760527.aspx

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Whats the right age for bariatric surgery?

Bariatric surgery on an eleven-month-old child in Mumbais Breach Candy Hospital has set off a heated debate among doctors on the ethics of such surgery on an infant. The child, already weighing 19 kgs at eleven months, was suffering severe respiratory problems. She is said to have monogenic syndrome, a genetic disorder, which claimed the life of her brother at the age of 18 months. Given the loss of one child in the family, and the inability to control the weight gain as she grew older, the family decided to go in for a sleeve gastrectomy, performed by Dr Sanjay Borude. The doctor is quoted as saying that the surgery should control the babys weight gain for at least the next three or four years. However, others in the profession have expressed the view that since this is not a case of overeating, bariatric surgery may not have been the best option. They have said that since the genetic disorder continues to exist, merely reducing the size of the stomach is unlikely to do much good. Another area of doubt relates to the age of the patient. While India has no guidelines in place on the minimum age for bariatric surgery, in the US the minimum prescribed age is 18 years. According to Dr Borude, She has already developed respiratory problems due to which she has been suffering from breathlessness. A little more weight can prove bad for her. He added, The surgery could have been done later but the child has to survive till then. We did not want to take any chances. The childs parents, who are not well off, are happy that the surgery, which was done free of charge, seems to have given her some hope of a normal future.

the next day, apparently of exhaustion. Balajis family said he received medical aid only after a couple of hours. While thousands took part in this archaic test, 1,240 candidates fainted in the heat, according to Kishore Tiwari of the Vidarbha Jan Andolan Samiti. Tiwari stated this to counter the forest officials claim that Balaji may have died due to a kidney ailment. The Samiti has approached the state human rights commission to review the case and recommend compensation for Balajis family. It has also demanded that the Forest Department revise its recruitment rules and cut the length of the race. On the intervention of the state human rights commission, the department has now agreed to check all candidates after the first five km before allowing them to continue. It will also make it compulsory for applicants to produce a fitness certificate before running. The department has defended itself saying that the stringent provisions of the Forest Conservation Act and the Wildlife Protection Act prohibit the building of roads in the forest area, hence the work requires men who are fit enough to function under such conditions. They claim such tests help them to gauge a persons capacity for the job. The Commission is said to have asked for the rules to be revised in writing. Meanwhile, the department has paid compensation of Rs two lakh to Balajis family.

Yogesh Naik, 5-km risk test in forest job marathon, Mumbai Mirror, October 26, 2011. Available from: http://www.mumbaimirror.com/article/2/ 2011102620111026020201404bc6fe9f5/5km-%E2% 80%98risk-test%E2%80%99-in-forest--job-marathon. html Mumbai Mirror Bureau, Yavatmal youth dies while chasing forest job, Mumbai Mirror.com, September 21, Jyoti Shelar, Infants fat surgery leaves docs divided, 2011. Available from: http://www.mumbaimirror.com/ Mumbai Mirror.com, November 25, 2011. Available from: article/2/2011102620111026020201404bc6fe9f5/5kmhttp://www.mumbaimirror.com/index.aspx?page=article& %E2%80%98risk-test%E2%80%99-in-forest--jobsectid=15&contentid=2011112520111125090939157b01b marathon.html?pageno=1 23a8

Surviving an archaic test

Desperate for a job, Balaji Trimanwar, the son of a Yavatmal farmer, took part in a 26-km run, a required test for aspirants to jobs as forest guards. Just 23, he collapsed in a pit and died

Contributions from Maithreyi and from Meenakshi Dcruz Compiled by Meenakshi Dcruz e-mail: meenakshidcruz@ gmail.com

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artiCles

International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in Paragraph 32
AY MALIK1, F GHAFOOr 2
1

Wellcome Trust D Phil student, Ethox Centre, Department of Public Health, University of Oxford, Oxford, OX3 7LF UNITED KINGDOM e-mail: aisha.malik@ethox.ox.ac. uk 2 Pakistan Medical research Council, Sheikh Zayed Medical Complex, Lahore PAKISTAN e-mail: fghafoor99@hotmail.com

Abstract
Inequities in socio-economic and healthcare systems between developed and developing countries have been thrown into sharp relief by globalisation. At the same time, pharmaceutical companies have started conducting clinical trials in developing countries in order to reduce their costs substantially. Together, these two developments create ethical challenges for sponsors and researchers of these trials. One such challenge is that of placebo-controlled trials (PCTs). In this paper we analyse Paragraph 32 of the Declaration of Helsinki referring to PCTs, identifying ambiguities in the wording, and then examine three arguments presented by sponsors of PCTs in developing countries, in defence of such trials. These arguments are: (i) a placebo control provides a definitive answer, and is therefore methodologically superior; (ii) placebo-controlled trials are ethical because they serve the principle of utility, and (iii) interpreting the best current proven intervention as the local standard of care allows PCTs to be conducted, if the local standard of care is no treatment We . argue that PCTs are not methodologically superior; nor are they ethically defensible. Other trial designs conforming to the ethics of research are feasible; the reason for conducting PCTs is expediency. We further propose that, given the global applicability of the Declaration of Helsinki, it is imperative to remove the ambiguities in Paragraph 32. In the context of collaborative trials, when a treatment exists, conducting PCTs is ethically unacceptable, irrespective of the geographic location of the trial. Universal standards ought to be applied universally.

countries is of interest to pharmaceutical companies. These companies reduce their costs substantially by conducting trials in developing countries. These factors together raise the possibility that patients in developing countries may be exploited (6-9), posing ethical challenges for researchers as well as sponsors of clinical trials. Some of the challenges are related to the provision of post-trial benefits to the host community, the use of a placebo in the control arm, and treatment and compensation for research-related injuries. The Declaration of Helsinki (DoH) is a key document in the ethics of international research involving human participants. It has been revised many times and each time important questions of clarification have arisen. Paragraph 32 of the DoH refers to the use of a placebo control. In this paper we focus on the use of placebo-controlled trials (PCTs) in developing countries. It begins with an analysis of Paragraph 32 of the DoH, and is followed by the enumeration of three justifications given in favour of PCTs, and our arguments against them. We use the paradigm case of the short course azidothymidine (AZT) trials in Africa as a backdrop to examine the arguments. In 1994, more than 12,000 HIV positive pregnant women in SubSaharan Africa were enrolled in randomised controlled trials of a treatment regimen to prevent mother-to-child transmission of HIV. Randomised controlled trials are considered the gold standard of research in order to establish the safety and efficacy of a drug. This treatment regimen using a short course of the drug AZT was based on the 076 regimen that had been found effective, a little earlier, by the AIDS Clinical Trials Group study 076. The 076 regimen was available to patients in the developed world. However, the short course regimen would be much cheaper than 076. Of the 12,000 women, half were given the test drug (short course AZT) and half were given placebo. This provoked a heated international controversy on the ethics of conducting placebo-controlled trials when an effective treatment 076 existed in the sponsoring country (10-11) and eventually led to a number of revisions in the Declaration of Helsinki. Finally, we conclude that Paragraph 32 of the DoH must state unequivocally that conducting a PCT when treatment exists is ethically tenuous, irrespective of the geographic location of the trial.

Introduction
Globalisation has brought to the fore inequities in socioeconomic and healthcare systems in the developed and developing worlds (1-2). Health spending in the least developed countries is US$11 per person per annum compared to US$1,900-2,000 per person per annum in high income countries. The expenditure in the former is well short of the US$30-40 per person per annum recommended by the World Health Organisation (3), required to cover basic treatment and care for major communicable diseases like HIV/AIDS, TB and malaria (4). Thus, in resource-poor countries, the meagre amount allocated for healthcare results in minimum healthcare provision sometimes none for its citizens. This creates a situation in which patients may view enrolling in a trial as the only way to access healthcare (5). From another point of view, the large pool of potential research participants in developing

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The Declaration of Helsinki

The Declaration of Helsinki is the leading international standard of ethical principles for medical research involving human participants (12). Since it was first issued in 1964, it has undergone a number of revisions. The latest revision addresses issues related to post-trial benefits, research-related injuries and the use of a placebo control. However, the DoH has not resolved the question of whether the use of placebos in collaborative trials is ethical when there is a proven intervention in the sponsoring country for the condition that the experimental drug will treat. (This is of concern because in such circumstances, participants on placebo would be deprived of an effective treatment, thus subjecting them to harm.) As a result, PCTs are still conducted and the debate on the ethics of PCTs is ongoing (13-17). The DoH was last revised in October 2008. One important clarification was in Paragraph 32 concerning PCTs. The paragraph now reads: The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention except in the following circumstances:
l The use of placebo, or no treatment, is acceptable in studies

trials is permissible, even though the proven intervention exists in the sponsoring country. Third, the confusion is further aggravated if we permit PCTs for compelling and scientifically sound methodological reasons . These reasons too can be arbitrary. For example, some sponsors and researchers may have difficulty in designing non-placebocontrolled trials for developing countries. Following from the discussion above, depending on the interpretation of the phrases, placebo-controlled trials may or may not conform to the DoHs ethical guidelines. Various arguments are made to support the use of PCTs in developing countries even though an effective intervention exists for the condition to be treated. We discuss these below.

I. Placebo control and definitive answers

One argument in support of a placebo control is that comparing the test drug with a placebo provides a definitive answer to the efficacy of that drug; PCTs will show an absolute benefit. Interpreting paragraph 32 as referring to the geographic location where no treatment exists and supporting it for a compelling and scientifically sound methodological reason , it is argued that a PCT, unlike an active control trial (in which the control group is given another, effective drug), provides a definitive answer to the efficacy of the test drug (19). This implies that PCTs are able to distinguish between active and inactive treatments and therefore methodologically superior (20). Any study that shows the superiority of a treatment to a control (whether placebo or active therapy) provides strong evidence of the effectiveness of the new treatment (21). Therefore, conducting a PCT would provide a definitive answer and validate the provision of a proven effective test drug in the host country (as in the PCTs of short course treatment to prevent HIV transmission in Africa); governments require convincing evidence about treatment efficacy in order to make sound public health policy decisions regarding allocation of funds (22-23). However, a concern here is that since PCTs can only answer the question of whether something is better than nothing even minimal efficacy would appear magnified. , We suggest that alternative trial designs can be formulated in which an effective treatment (available in the sponsoring country) is provided to the control group. Conducting this active control trial would establish whether the investigational intervention is better or worse than, or equivalent to, the standard treatment in efficacy and safety (24-25). And that is what needs to be known: how does the new drug fare when compared with what we are using at present? A second alternative to PCT is using information sources external to the trial, which can provide a valid and reliable basis for evaluation of the new drug (21). This information can be from historical controls. Yet another methodology could be to start with a small cohort of patients and as soon as the efficacy of the intervention is determined, the data monitoring and safety board could expedite the use of the new drug for the rest of the patients. We suggest this possibility based on the

where no current proven intervention exists; or

l Where for compelling and scientifically sound methodological

reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option. (18: para.32)[emphasis added] Below, we argue that the interpretation of these phrases is not self-evident and, in the context of international collaborative research, these guidelines do not provide clear guidance. First, it is not clear what the locale is of the best current proven intervention against which the new intervention is to be tested. It could be the current proven intervention in the sponsoring country or the current (usual and available) intervention in the host community where the patients are enrolled. Second, it is not clear whether the phrase studies where no current proven intervention exists refers to the geographic location of the study, that is, when a study is conducted in locations where no current proven intervention or treatment exists. It can also be interpreted to refer to the disease under investigation for which no current treatment exists anywhere, and the purpose of the trial is to find a treatment. If the phrase means the latter, then the use of a placebo for the control group is acceptable. However, if the phrase refers to the geographic location of the studies, then it feeds into the assumption that a placebo control is permissible in studies conducted in locations where no treatment for that particular disease exists. In the context of international collaborative trials, it leads to the inappropriate conclusion that in countries where no proven intervention currently exists, conducting placebo-controlled

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protocol followed by Sperling et al (26). Therefore, if paragraph 32 were interpreted to refer only to diseases for which no treatment exists anywhere, this would represent a justifiable, ethical, use of placebo controls. Once a treatment becomes established, the new drug regimen must be tested against it (27-28).This ought to be implemented wherever collaborative research is conducted, reiterating the ethical interpretation of the phrase; to deny patients effective treatment in order to influence health policy is as bad in developing countries as it is in developed countries (13).

in developing countries was used by researchers in developed countries to create more effective treatment regimens for patients in developed countries (38). Placebos and non-maleficence PCTs are also beset by another consideration that is both practical and ethical: participants in a trial need to be informed that during randomisation they may be assigned to the placebo arm. However, potential participants may be more likely to consent to a trial where they are certain to receive an active treatment than they are if they might get a placebo (31: 43). There may be problems of noncompliance when these patients either do not take the placebo medicine or , withdraw, or covertly seek treatment (31). As stated earlier, it is the provision of treatment that impels patients to enrol in many trials in developing countries (5, 39-41). Even Miller and Brody who are proponents of PCTs write: placebo controlled trials raise ethical concerns insofar as they have the potential to exploit the research participants by exposing them to excessive risks from placebo assignment.(42:8). Placebo and equipoise An ethical prerequisite for starting a randomised controlled trial is clinical equipoise, a state in which the medical community, on the basis of available data, is equally poised between the two treatments being tested. According to Freedman et al: As a normative matter, it defines ethical trial design as prohibiting any compromise of a patients right to medical treatment by enrolling in a studythese principles allow for testing new agents. At the same time they foreclose the use of placebos in the face of established treatment. (32: 244-5) If the phrase studies where no current proven intervention exists is interpreted to mean the location of the trial where no treatment exists, then by conducting PCTs, the indeterminacy of treatment options is lost; that is, equipoise does not exist because when one compares the test drug with no treatment (placebo) then the advantages of the former over the latter are already established: placebos cannot treat a disease. Furthermore, randomised controlled trials are phase 3 trials (phase 1 being primarily for safety and phase 2 for safety and efficacy on small numbers of participants) by which time preliminary data from earlier phases provides some information about the potential benefits of the test drug (43) that would suggest that the new therapy is better than placebo (44). We argue that conducting a PCT in the light of such evidence -- where equipoise is lost -- is ethically tenuous. Since science and ethics are not separate, it is necessary that in conducting research on human participants the scientific merit of the research must be matched by the ethical merit of the work (45-46).

II. Placebo controls and ethics

The second argument in favour of conducting a PCT is based on a principle of ethics, that of utility, which is to always produce the maximal balance of positive value over negative value. Resnik argues that PCTs provide quicker and more reliable answers to scientific questions PCTs are more efficient (29). However, using a utilitarian calculation to justify placebo use in conditions that result in morbidity, and/or mortality, violates the principle of beneficence, even if consent is obtained (30). Resnik further argues that ethical principles sometimes conflict with the scientific rigour of the trial: this argument was based on the assumption that PCTs are methodologically superior and hence beneficence and informed consent may be trumped by scientific rigour, justice and social utility(29:298). However, as shown above, in order that the principle of utility (and beneficence) is not compromised, alternative trial designs can be formulated. Moreover, statistical analysis shows that the number of participants required in an active control trial and a placebo-controlled one is similar (17, 31-32). It is noteworthy that the phenomenon of placebo effect, wherein the placebo mimics the active drug response (33), can contribute to the variability in outcome data (34). This has implications: if the placebo effect is strong then the number of patients required to overcome this effect will increase (35). Placebos and justice The principle of justice may be violated by conducting PCTs. It is plausible that if an active control trial in developing countries identified effective but less expensive and less toxic drugs, then these regimens would be implemented in the developed world (36). Or if the superiority of one drug were to be established over the other when both ran against each other, the result could have implications, both therapeutic and economic, in developed countries (37). This can have major financial implications for companies that have already established a market for one drug. If the cheaper regimen turns out to be more effective than the established treatment, or if it turns out to be equally effective, then the companies could lose substantially. In the case of the HIV/AIDS trials, the success rate in reducing mother-to-child transmission was considerably higher in developed countries where the 076 regimen was in use; but not in developing countries, where a short regimen was in use. However, the point to note here is that the knowledge generated through the use of the short regimen

III. Placebo control and standard of care

This argument in favour of PCTs depends on ambiguities in the DoH. In the past the current proven method was interpreted as standard of care (in its narrow interpretation) which was again subjected to varied interpretations. Depending on the

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frame of reference, it meant either standard medical practice in the host country or the universal standard of care if the frame of reference was a practice with widespread acceptance among the medical profession worldwide. In other words, it was a normative standard set by the judgement of experts in the medical community, and not a description of the local practice (47). Similarly, if the phrase studies where no current proven intervention exists is interpreted by sponsors as: studies conducted at locations where no treatment exists; by deduction, placebo control is acceptable. This argument resonates with the claims that in Sub-Saharan Africa, the local standard of care was no treatment and hence use of placebo was justified (37) and left no woman worse off; on the contrary at least some benefited from the test drug (23, 48). An argument like this would be unacceptable to ethics committees in a developed country which do not allow PCTs when effective treatment exists, even though these treatments are not accessible to a substantial number of their people (49). If antibiotics are not available in a community, it does not mean that the standard care for infections in this community is no treatment; since the standard care for infections is antibiotics. All it means is that the drugs are not available in that community, and this non-availability is determined by vested interests driven by economic considerations (50). No standard can be set in circumstances of deprivation and fiscal constraint, and the argument that no treatment is standard care at a certain locale is a misinterpretation of Paragraph 32 of DoH, used to substantiate the use of placebos in the control group. The phrase studies where no current proven intervention exists could be misinterpreted to strengthen the arguments for conducting PCTs in developing countries (as did the standard of care debate) but this would contravene the DoHs more unambiguous paragraph: it is the duty of the physician in medical research to protect the life, health and dignity of the subject(18: para.11). The guidelines have been formulated so that the subjects welfare is not subordinated to the objectives of the research and came into being as a consequence of (some) scientists misadventures. Now, the moral obligation is to avoid acts that would contravene the deontological imperative of the medical profession to do no harm . Although Ellenberg and Temple make exceptions to the use of placebo controls in conditions where temporary discomfort may occur; omitting proven therapy is not an option where morbidity and mortality may result (51). A trial which places the trial participants life and health in jeopardy by using less than the effective standard treatment would not be permitted in the sponsoring country; because the local standard of care is the same as the universal standard of care so anything less would not have sufficient social value to justify its risks(48:926). Arguably, there are marginalised people in sponsoring countries who do not have access to standard healthcare (52). Even so, the use of a placebo (in the presence of a proven intervention) would not be approved by their ethics review

boards. Therefore, if conducting placebo-controlled trials in the sponsoring country is unethical, then exporting them to developing countries is also unethical (53); in other words, the researchers and sponsors are guilty of double standards. Sponsors of collaborative trials, interpreting the phrase studies where no current proven intervention exists as the locale of the study where no treatment exists and buttressing it on scientifically sound methodological reasons could then conduct a PCT(6). As established earlier, this claim is not based on scientifically sound reasoning, nor is it ethically valid, hence its removal brings to the surface other reasons for misinterpreting Paragraph 32 and conducting PCTs in the developing world. These are exclusively based on expediency: financial advantage and ease in enrolling patients (7, 9, 30,50,54). In developing countries, research participants lack of knowledge regarding disease and their rights places them in a position where the interests of science and the common good can take precedence over the research participants own well being (55-56). However all research subjects are entitled to minimum guarantees that are transnational and non-negotiable (57:545). Concerns have been raised that some sponsors and researchers, by conducting unethical research, denigrate the integrity of those who perform ethical research (58). In the HIV/AIDS trials conducted in Sub-Saharan Africa, of the 12,000 women participating, 6,000 received the test drug and benefited. The other 6,000 received placebos -- in others words they received nothing. Thus, the researchers knowingly failed to minimise harm to those research participants (53). When the reason for conducting PCTs in a developing country is financial, it is necessary to remember that healthcare provision in developing countries is minimal and sparse. In such circumstances, it has been argued, high standards should be set by bringing in new resources to deal with old problems (59). The wide disparities in the healthcare systems of the developed and developing countries require a commitment so that people in the latter also benefit from scientific and economic progress and not just peripheral benefits (60). A step forward would be if each successive research project were to leave the host community benefitted; over a period of time a cumulative effect would help reduce this inequity (30).

Conclusion
Pursuing the path of least resistance in order to expedite trials jeopardises the lives (and liberty) of patients living in developing countries; it is morally (and ethically) commendable to design trials (and policies) that help reduce inequities between developed and developing countries and do not promote double standards. The purpose of revising the Declaration of Helsinki is to remove ambiguities and prevent the conduct of unethical trials. Members of the scientific community and ethics review committees ought to be sensitive to the health needs (and rights) of their fellow citizens. They should enter into deliberations so that each successive trial reduces health inequities between the developed and the developing worlds. It is a normative requirement that universal

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standards ought to be applied universally.

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Less equal than others? Experiences of AYUSH medical officers in primary health centres in Andhra Pradesh
JK LAKSHMI
Indian Institute of Public Health, Hyderabad (Public Health Foundation of India), Plot # 1, A N V Arcade, Amar Co-operative Society, Kavuri Hills, Madhapur, Hyderabad 500 081 INDIA e-mail: jklakshmi@iiphh.org

Abstract
The National Rural Health Mission (NRHM) includes, inter alia, the establishment of an AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) component (practitioner, trained assistants, drugs and equipment) in every primary health centre (PHC). However, five years following the launch of the NRHM, the AYUSH mainstreaming scenario is below expectations, riddled with ethical and governance issues. Accounts from AYUSH practitioners at PHCs in various regions of the state of Andhra Pradesh reveal enormous lacunae in implementation: unfilled positions, inequitable emoluments, inadequate or absent infrastructure, assistance and supplies, unethical interpersonal arrangements, and limited support from non-AYUSH personnel. The widespread negative impact of these conditions undermines the value of AYUSH, demotivating both practitioners and patients, and failing to provide the intended support to the public health system. .

indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. Complementary/alternative medicine (CAM): The terms complementary medicine or alternative medicine are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that countrys own tradition and are not integrated into the dominant health care system. Based on its provenance, context and employment, a system may be traditional, complementary or alternative, or a combination of these. For example, ayurveda used concurrently with allopathy in India is traditional and complementary; homoeopathy used instead of allopathy in India is alternative .

Introduction
Traditional, complementary and alternative medicine (TCAM) are therapeutic systems distinct from the dominant allopathic system followed in mainstream medical practice. They are classified as complementary when employed in tandem with the dominant system, and alternative when employed instead of it. The World Health Organisation defines traditional, complementary and alternative medicine (TCAM) as follows (1): Traditional medicine: Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences

TCAM in the Indian health system

Allopathy is the dominant health care system in India.Nonallopathic therapeutic systems find a place in the formal health system in the country under a department of the ministry of health and family welfare (MoHFW). This department was established as the department of Indian systems of medicine and homoeopathy (ISMandH) in 1995, and renamed the department of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) in 2003 (2). It governs the education, research, practice and quality of all the systems

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represented in the acronym AYUSH and in addition, a , therapeutic system known as sowa-rigpa, or amchi, practised in the Himalayan regions and some parts of north east India. The years since the establishment of the department of AYUSH have witnessed considerable growth in AYUSH educational institutions (undergraduate and post graduate), hospitals, dispensaries and drug manufacturing units (3). The rational use of TCAM is increasingly recognised as a vital public health need. Some of the reasons are: escalation in noncommunicable and chronic diseases; resurgence of certain communicable diseases and emergence of new diseases; drug resistance; and a growing consciousness of the need to incorporate healthy behaviours into our daily lives. This awareness is expressed in international and national policies to mainstream TCAM(4), including promoting research, education, licensing, drug-standardisation and regulation, and awarenessraising. The NRHM in India is a case in point. It incorporates policies and strategies for the mainstreaming of AYUSH, with special emphasis on skill development and infrastructural support for AYUSH personnel.

naturopathy, homoeopathy, and unani were approached and communicated with. No siddha practitioner could be accessed as there are none appointed in PHCs in Andhra Pradesh at present. Responses were gathered from discussions in dyads, or in small groups of three to six doctors, yielding rich accounts of the experiences of AYUSH doctors in the NRHM. Thirty AYUSH doctors in all participated in 10 of these discussions, each of which lasted between 10 and 30 minutes. The narratives, besides highlighting a few good practices in certain PHCs, point to numerous lacunae in the implementation of the mainstreaming initiatives in the NRHM. Data gathered on these shortcomings were interpreted, and grouped into five major categories: recruitment, remuneration, facilities, technical support, and interpersonal relationships.

Recruitment
The 1,525 PHCs in Andhra Pradesh entail the appointment of an equal number of AYUSH medical officers. The positions were mandated to be filled in three phases by the year 2009. However, over 50 percent of the AYUSH medical officer positions in Andhra Pradesh were unfilled in the year 2010, the majority through never having been filled, and a few through the dismissal of the serving AYUSH medical officer. A recent review of the NRHM (6) reports that only 29 percent of PHCs across India have integrated AYUSH staff into their personnel. The low proportion of filled AYUSH medical officer positions in Andhra Pradesh, (approximately 43 percent according to a 2010 report (7)) though not as bleak as the national average, is nevertheless a cause for concern. But, although the quantum of recruitment is well below the target, the process of recruitment is commended by AYUSH doctors as transparent and in accordance with stated policy, beginning with advertising in leading newspapers, and guided by merit, and the governments categories of reservations. The contracts, under which AYUSH doctors are recruited to PHCs under the NRHM initiative, which are meant to be renewed annually, are often not renewed in a timely manner. Many doctors report their continuing to work for months, despite the lapse of their contracts, with the implicit understanding that the delay in renewal is an expression of administrative inertia, rather than a herald of dismissal. The delay, sometimes over six months, in the renewal of contracts is observed to be a feature only of the AYUSH personnel appointments, and not of other contractual executives of the NRHM. The contractual AYUSH medical officers report to the regional deputy director of their respective zone, under the commissioner of AYUSH of the state. Despatches include the regular attendance report (attested by the allopathic medical officer at the PHC), and the out-patient report of the consultations performed. The regional deputy director is also the official who disburses the AYUSH medical officers salaries.

AYUSH in the NrHM

The NRHM, launched in 2005 to fortify public health in India, sought to revitalise and mainstream AYUSH, specifically to strengthen human resources, infrastructure and drug quality and standardisation, supported by advocacy for AYUSH, and the establishment of inter-sectoral linkages to facilitate AYUSH practice. Activities under this initiative include facilitation of specialised AYUSH practice, integration of AYUSH practitioners in national health programmes, integration of AYUSH modalities in primary health care, strengthening the governance of AYUSH practice, supporting AYUSH education, establishing laboratories and research facilities for AYUSH, and providing infrastructural support (5). Actions pertaining to human resources and practice include contractual appointment of AYUSH doctors in community health centres (CHCs) and PHCs; appointment of paramedics, compounders, data assistants, and managers to support AYUSH practice; establishment of specialised therapy centres; involvement of AYUSH doctors in national disease control programmes; and incorporation of AYUSH drugs into community health workers primary healthcare kits.

Experiences of AYUSH practitioners under the NrHM

The observations made here were generated from interactions with a cross-section of AYUSH doctors contracted to medical officer posts in PHCs in Andhra Pradesh. This was supplemented by a visit to a PHC staffed by an AYUSH doctor, and the perusal of the limited formal literature on the evaluation of the integration of AYUSH into mainstream public health in India. AYUSH medical officers were contacted informally over several weeks, from March to June 2010, during training programmes that they attended, in batches drawn from all the districts of the state, and asked about their experiences in their PHCs. Medical officers practising ayurveda, yoga and

Remuneration
AYUSH medical officers unvaryingly lament their meagre salaries, as being well below the emoluments of allopathic

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Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

colleagues. The current consolidated monthly salary of Rs 9,300 (8) is reported to be based on a previous calculation of the basic pay of allopathic medical officers, and precludes both the increments in said basic pay over the years, as well as all the substantial allowances which are added to the basic pay to form the allopathic medical officers salary. AYUSH medical officers in PHCs in Andhra Pradesh cite the comparatively higher emoluments of certain unskilled support staff in allopathic hospitals to underscore their frustration at the low salaries that they receive. The insufficiency of the salary is acknowledged in several submissions to the government, by AYUSH medical officer associations as well as their administrative superiors, for enhancement of pay, and an approach to parity with AYUSH medical officers salaries in other states, as well as the basic (unconsolidated) pay of allopathic medical officers, which is Rs. 15,600 at present (8,9). There are very few contractual allopathic medical officer positions for comparison: These positions come with a salary equal to the basic pay of regular allopathic medical officers, which, as detailed above, is considerably higher than the contractual AYUSH medical officers salary. Other (nonAYUSH) contractual employees salaries are regularly revised in accordance with Pay Commission recommendations, unlike contractual AYUSH doctors salaries. The contractual position does not offer any perquisites, such as benefits or allowances for family, health, housing, education, and geographic location. The working hours of AYUSH medical officers are the same as those of allopathic medical officers. The range of responsibilities is different however: AYUSH personnel are not assigned emergency duties and obstetric duties. AYUSH doctors are justifiably exempt from the emergency allowance over their basic pay, but the denial of a rural allowance for geographic location is not defensible. There is no overlap or express sharing of responsibilities between the AYUSH and non-AYUSH departments of the PHC. In addition to the salary, each AYUSH medical officer is allocated a contingency fund to cover expenses not already accounted for. This contingency fund, ostensibly usable for some equipment, stationery, repairs etc, is not conveyed in a timely manner to all the AYUSH medical officers. Some report not receiving the fund at all, and going to the extent of using their personal funds to institute minor repairs, and installation of equipment, such as signboards, in the PHC.

being pressed into service as consulting, drug storage, and drug dispensing spaces. Besides space, furniture and equipment are reported to be in short supply in several PHCs. The supply and replenishment of medications, across systems of AYUSH, leave a lot to be desired at many PHCs. While some doctors complained of the delay of several months, in the initial stocking of medications, others reported prompt primary stocking followed by months without replenishment. Considering that many AYUSH medications, eg certain ayurvedic and unani formulations, are too expensive for PHC patients to afford to procure from private pharmacies, this inadequate supply may mean the difference between receiving AYUSH treatment and being denied it. The inability to obtain stocks of appropriate medication is a common grievance of AYUSH doctors in PHCs across the nation, as revealed by an evaluation of service delivery under the NRHM in four states (11).

Technical support
Every PHC is expected to be populated with a trained AYUSH compounder, an assistant to dispense medication and provide therapeutic services on the prescription of the medical officer. Reports reveal that the position of an assistant is not filled in some PHCs, and that assistants appointed at certain PHCs are not appropriately skilled, leaving the doctor to undertake the dispensing in addition to the prescription. For instance, some individuals appointed to assist unani medical officers, are not literate in Urdu, and thereby not competent to decipher prescriptions in Urdu and dispense medications labelled in Urdu. Besides the compounder, every AYUSH medical officer is assigned a sweeper and nursing orderly, to help with the maintenance of the AYUSH facility at the PHC and with patient flow during consultation hours: This post is also unfilled in some cases. It bears mentioning that the emoluments of the AYUSH support staff are low, specifically Rs. 4800 per month for a compounder, and Rs. 3900 per month for a sweeper and nursing orderly (9).

Interpersonal relationships
A few AYUSH medical officers enjoy collegial and cordial relationships with their allopathic counterparts, as well as the other personnel working at the PHC. Some report minimal interaction, and no adverse communication, with the allopathic medical officer and other PHC personnel. Several others recount unpleasant interactions with the allopathic medical officer, and several of the other PHC personnel. These range from tacit disapproval and deprecatory references by the nonAYUSH personnel at the PHC, to verbal discouragement of potential patients from visiting the AYUSH doctor, and blatantly unethical interpersonal arrangements between the allopathic and AYUSH doctors. For instance, the allopathic medical officer may fraudulently document the attendance of the absent AYUSH medical officer, in exchange for a financial consideration, or as part of a reciprocal arrangement. Some AYUSH doctors are reported to have been asked to perform case-taking, diagnosis and prescription of allopathic medications on behalf of the

Facilities
Each medical officer is expected to be furnished with a consultation chamber, a dispensing zone, and a waiting area for patients, adding up to a minimum of 800 square feet of space (10). This includes provision for fresh construction of a building in situations where the existing structure cannot accommodate the AYUSH facility, and the PHC site has enough space. While some AYUSH doctors report satisfactory, and a small minority, excellent, infrastructural provision, numerous doctors describe the premises provided to them as grossly inadequate. Accounts were communicated of verandahs and cramped storerooms

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absent allopathic medical officer. This is clearly against the law, not to mention unethical, as not all AYUSH students are trained in allopathic pharmacology and licensed to prescribe allopathic medications. In premises shared by allopathic and AYUSH medical officers, it is reported that the sweeper and nursing orderly assigned to the centre, although notionally able to work for the AYUSH facility as well as the allopathic, may not work at the AYUSH facility. AYUSH medical officers cite interpersonal tension and an antagonistic attitude towards AYUSH as reasons for this. The NRHM envisages the participation of AYUSH personnel in national health programmes(5). However, the guidelines for such participation are not elucidated, with the result that the involvement of AYUSH personnel in national programmes is predicated on the interpersonal equation between the allopathic medical officer and the AYUSH doctor. Thus, some PHCs see a high level of involvement of AYUSH personnel in national health programmes, some moderate, eg, participation in the pulse polio programme, and many others see no participation of AYUSH personnel in national health programmes. Clear guidelines on the roles of AYUSH medical officers in national health programmes are urgently needed to resolve this, to harness all health personnel appropriately, and strengthen national health programmes.

The dissonance between the stated goals of revitalising and mainstreaming AYUSH and the reality of inequitable implementation is patent. The injustice to AYUSH practitioners, and patients, and by extension to the national community, calls for a systematic evaluation of the integration (particularly the underlying structural and social issues) of AYUSH into the public health mainstream in India, and the implementation of prompt remedial measures. Acknowledgement The author is grateful to the AYUSH medical officers who articulated their experiences in PHCs, raised her consciousness of the technical, administrative and ethical issues encountered in the mainstreaming of AYUSH in PHCs in Andhra Pradesh, and present an inspiration in perseverance and dedication to their systems of medicine. Competing interests: none Funding support: The author was supported by the Indian Institute of Public Health, Hyderabad, during the process of gathering information and writing. No other funds were received or expended for this work.
references World Health Organisation. Traditional medicines: definitions [Internet]. Geneva: WHO;2011[cited 2011 Nov 8]. Available from: http://www.who. int/medicines/areas/traditional/definitions/en/index.html 2. Department of AYUSH,Ministry of Health and Family Welfare,Government of India. Welcome to AYUSH [Internet]. New Delhi: Government of India; 2011[cited 2011 Nov 8]. Available from: http://indianmedicine.nic.in/ index.asp?lang=1 3. Department of AYUSH, Ministry of Health and Family Welfare, Government of India. AYUSH in 2008 [Internet]. New Delhi; Government of India;2010[cited 2011 Nov 8]. Available from: http://indianmedicine. nic.in/index3.asp?sslid=388&subsublinkid=136&lang=1 4. World Health Organisation. WHO traditional medicine strategy 2002 - 2005[Internet]. Geneva:WHO;2005[cited 2011 Nov 8]. Available from: http://whqlibdoc.who.int/hq/2002/who_edm_trm_2002.1.pdf 5. National Rural Health Mission. Department of Health & Family Welfare, Government of Orissa. Mainstreaming AYUSH under NRHM [Internet]. New Delhi: Government of India; [cited 2011 Nov 25]. Available from: http://203.193.146.66/hfw/PDF/ayus.pdf 6. Husain Z. Health of the National Rural Health Mission. Econ Pol Wkly. 2011 Jan 22;46(4):53-60. 7. Planning and Evaluation Cell, Department of AYUSH, Ministry of Health and Family Welfare. Government of India. AYUSH Report 2010 [Internet]. New Delhi: Government of India 2010; [cited 2011 Nov 15]. Available from: http://www.similima.com/pdf/ayush-complete-report-2010.pdf 8. AYUSH Medical Officers Association, a. 2010 [Internet]. AYUSH Medical Officers Association: 2010[cited 2011 Jul 20]. Available from: http://apayushmosassnnrhm.com/pages/Pogroms_7.html 9. AYUSH Medical Officers Association, b. 2010 [Internet]. AYUSH Medical Officers Association: 2010[cited 2011 Jul 20]. Available from: http://apayushmosassnnrhm.com/pages/Pogroms_2.html 10. AYUSH Medical Officers Association, c. 2010 [Internet]. AYUSH Medical Officers Association: 2010[cited 2011 Jul 20]. Available from: http:// apayushmosassnnrhm.com/pages/Pogroms_5.html 11. Gill KA. Primary evaluation of service delivery under the National Rural Health Mission: findings from a study in Andhra Pradesh, Uttar Pradesh, Bihar and Rajasthan. Working Paper 1/2009, Planning Commission[Internet]. 2009[cited 2011 Nov 11]. Available from: http://planningcommission.nic.in/reports/wrkpapers/wrkp_1_09.pdf 1.

Conclusion
In summary, few AYUSH doctors report positive experiences of technical and social support in their work at PHCs. The straitened economic situation is universally lamented, by those with positive, as well as those with negative, social and infrastructural circumstances. AYUSH doctors observe that besides the few patients sceptical from the start, numerous patients enthusiastic at first get discouraged with time from using AYUSH treatments, under the conditions prevalent at several PHCs. The procedures to mainstream AYUSH in PHCs have placed AYUSH and allopathic systems in a largely parallel configuration with separate reporting channels, fiscal and logistical structures, and distinct duties not providing optimal scope for the deployment and development of AYUSH. The negative impact of the circumstances of AYUSH in PHCs is widespread, affecting practitioners, patients, and eventually the nation at large. The effects range from minor delays in treatment, to job-dissatisfaction, interpersonal tension and the calling into question of the professional integrity of medical practitioners. The value and practice of AYUSH are undermined, demotivating both practitioners and patients. The injury to public health lies in the denial of proper AYUSH treatment to the many who may desire, and benefit from, it; the denial of a platform to AYUSH practitioners to contribute to public health; and the denial to the nation of the public health gains to be made from the optimal application of AYUSH to public health challenges, including health promotion and disease prevention.

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Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

Continuing oversight through site monitoring: experiences of an institutional ethics committee in an Indian tertiary-care hospital
YASHASHrI C SHETTY1, PADMAJA MArATHE 2, SANDHYA KAMAT3, UrMILA THATTE4
1

Assistant Professor, 2 Associate Professor,3 Professor, Department of Pharmacology and Therapeutics, 4 Professor and head, Department of Clinical Pharmacology, Seth G S Medical College and K E M Hospital, Parel, Mumbai 400 012 INDIA Author for correspondence: Yashashri C Shetty e-mail: yashashrirajit@gmail.com

Abstract
WHO-TDR and the Indian Council of Medical Research recommend site visits by institutional ethics committees (IECs) for continued oversight, to ensure the ethical conduct of research. Our IEC conducted seven site visits in 2008-2009 using a standardised format to monitor adherence to protocol and the informed consent process. The study identified issues related to informed consent (6/7), deviation from protocol (5/7), reporting of study progress to the IEC (3/7), recruiting additional participants without IEC approval (2/7), reporting of serious adverse events (1/7), investigators lack of awareness of protocol and the informed consent document (2/7) and other findings. Investigators were informed about the findings and were asked to submit an explanation. The IEC issued warnings about not repeating such lapses in the future(5/7), restricted enrollment of new participants(2/7), recommended continued good clinical practice training to the study team (4/7), advised the recruitment of additional study coordinators(2/7), and requested the submission of adverse event reports(2/7) or sponsors audit reports(2/7). Our study showed that the ethical conduct of studies can be ensured by conducting routine site monitoring.

monitoring. Additionally, and perhaps as relevant, is the fact that all medical institutions take up investigator-initiated studies where sponsor-driven routine monitoring may not be carried out, emphasising the greater need for continued monitoring by IECs (6). As a strategy to address this issue, our IEC (located in a tertiary care hospital in India) conducted site monitoring visits according to pre-drafted standard operating procedures (SOPs) (7). Visits to different study sites were organised to monitor the conduct of the ongoing studies. The objectives of these visits were to check compliance of investigators with the protocol and the informed consent process approved by the IEC as well as to assess the level of understanding of the research participants. This paper discusses the observations made during site visits and the subsequent recommendations made to the investigators as also action taken by the IEC.

Methodology
Seven sites were monitored by members of the IEC between January 2008 and December 2010, using a standardised predecided format based on the SOPs (Appendix 1). The sites were selected for monitoring either for cause (n=5) including incomplete communication from the principal investigator (PI) regarding study progress, a large number of SAEs (deaths) reported from a site, large numbers of protocol deviations, recruitment of additional participants without approval of the IEC and a large number of studies undertaken by the PI at one site or routine (n=2) for investigator-initiated studies. The site visits were conducted according to the IECs SOP number 15 (7). The PIs were informed in writing two weeks in advance about the schedule of site visits, and their acceptance and availability were confirmed before conducting the visits. A team of two IEC members conducted the visits and noted down the observations in the site monitoring report (Appendix 1).The approval of the IEC was obtained to compile and analyse the site visit reports. The reports were analysed for violations and categorised under seven themes: (1) informed consent; (2) deviation from investigational plan , (3) non-reporting of study progress to IEC, (4) IEC approval (5) lack of investigator understanding of protocol and informed consent documents (ICD), (6) SAE reporting, and (7) other findings.

Introduction
The continuing review of approved research by institutional ethics committees (IECs) is essential to ensure the ethical conduct of clinical research. IECs perform this duty primarily by reviewing data submitted to them during the conduct of a trial at pre-specified regular intervals. This data includes serious adverse event (SAE) reports, progress reports, reviews of protocol violations, and of amendments of protocol, and related documents submitted by the investigators etc, as recommended under national and international guidelines and legislation (1-3). This is generally a form of passive monitoring . In order to ensure the safety and well being of participants ,as well as to ascertain that potential risks have not altered, these same guidelines also recommend site visits as one of the methods for continuing review by IECs (1-3). Site monitoring is a routine activity in the United Kingdom and research ECs carry out proactive monitoring through questionnaires and/or by visiting research sites for pharmaceutical industry-sponsored trials (4). However, IECs in India have neither the mechanisms in place nor the manpower or resources to meet this requirement, and therefore cannot fulfil this obligation (5). Consequently, they rely upon passive

results
Of the seven studies selected for monitoring, five were pharmaceutical industry-sponsored and two were investigator-

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initiated studies. All seven were drug trials. The most common findings in these audits were related to the informed consent process (6/7). Others included deviations from the investigational plan (5/7), non-reporting of the studys progress to the IEC (3/7), recruiting additional participants without IEC approval (2/7), lack of investigator awareness regarding the protocol and informed consent document (3/7), and serious adverse event reporting (1/7). In addition to the above, some other findings were also noted, all of which have been summarised in Table 1. Table 1: Violation themes observed during site monitoring by IEC Monitoring sites Violation theme (n=7) Informed consent issues Deviation from investigational plan Non-reporting of study progress to IEC Deficiencies in study supervision IEC approval Lack of investigators understanding about protocol and informed consent document Serious adverse event reporting Other findings No source documents found; No coded drugs used; Documents not kept under lock and key; Auditors monitoring report missing; PI reported SAE late; Biodata of investigators in the project file not signed 1/7 [ one observation was noted in each of the 7 studies monitored] 6/7 5/7 3/7 2/7 2/7 3/7

in Marathi (local language) and had signed the English consent form in Marathi. The explanation given by the investigator was that the patients signatures were obtained only after explaining everything to them. In one case, the ICD was signed 10 days after obtaining the participants signature by the PI and co-investigator (Co-I). In one ICD, a nurse of the Institute was used as an impartial witness. In one study, names of all the 30 participants and dates had been filled in by the PI. Without documenting the participants consent on the ICD, all the data had been filled in into the case record forms. In one study, informed consent was re-obtained from participants with an amended (approved by IRB) version of the ICD containing information on important new side effects after a delay of 1-3 months. The informed consent addendum was signed by the PI and the Co-I 10 days later, and in the case of 30 participants, a copy of the ICD had not been given to any of them. In order to assess the participants understanding of the study, one participant of each of three studies (a total of three participants) was interviewed. Since the participants were not familiar with the English language, they were interviewed in the local language. It was observed that the participants had a good understanding of the study and the drugs given. They could explain the risks and discomforts of participation in the study. One of the participants relatives confided that they were participating in the study as they received free treatment.

Deviations from the investigational plan

1/7 At one of the sites, investigators were using an older version of the study protocol. For the investigator-initiated study, participants were not randomised as required in the protocol.

Failure to report study progress to IEC

As per the SOP, our IECs grant approval for a period of one year and then extension of approval after reviewing the annual status report of the study. There was a lapse in submitting the annual status report and taking extension of approval by one of the PIs and 85/125 patients were recruited during the period not covered by valid approval of the IEC.

The informed consent process

Six of the seven sites monitored had issues concerning the process of documenting informed consent. Copies of the informed consent documents (ICD) were not available at the site. The explanation given by the investigator was that as it was a collaborative study, the ICDs were archived with the other institution, in spite of the fact that the patients had been recruited from our institution. Other findings included missing signatures of patients (n=1) and principal investigator (n=2). The consent of four participants had been obtained using the vernacular (Hindi) consent form which had not been approved by the IEC, while only the English version had approval. In one study, we found that six participants had been administered the English version of the ICD when they were actually literate

Recruitment of additional participants without IEC approval

In one of the sponsored studies, the IEC had given permission for recruiting 25 patients while the PI had recruited 30 patients.

Lack of investigator awareness regarding the protocol and informed consent document
At six sites, investigators were interviewed to verify their awareness of the protocol. In one study, the PI did not know the inclusion criteria. At another study site, a ready-reckoner of selection criteria prepared by investigators to facilitate recruitment of participants was found incomplete. This could have led to protocol violations in recruitment. At three sites, when Co-Is were interviewed in the absence of PIs, it was observed that answers given by Co-Is to questions

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on inclusion criteria were inappropriate. One Co-I commented that an elaborate consent process would deter patients from participating in the study. In two investigator-initiated studies, the investigators (post-graduate students) were not aware that source documents had to be maintained; patients were not being randomised according to the charts; ICDs that were administered to the participant were not in the language that the patient understood; and participants had not been given a copy of the ICD.

training of resident doctors in clinical research. PIs who did not keep their documents securely under lock and key were asked to make arrangements to do so. Table 2: Action taken by IEC against monitoring sites. Violation theme Protocol deviation Action taken by IEC Explanation asked for with a clear warning against future repetition

SAE reporting
A total of 20 SAEs from the 1/7 sites were reported to the IEC after seven working days.

Deviation from Restriction on future recruitment, investigational plan submission of audit reports from sponsor Non-reporting of study progress to IEC Deficiencies in study supervision SAE reporting Explanation asked for with a clear warning against future repetition Recruitment of additional members in the study team advised Submission of AE reports

Other findings
All the case record forms were found to be incompletely filled in with pencil [25/25] at one site. One of the sites had been monitored by the sponsor, but the monitoring report was missing. The bio-data of the investigators in the project file had not been signed. No source documents were found at two study sites. Documents were not kept under lock and key. A single study co-ordinator was handling multiple studies. At one site, the study had been initiated without having received the approval of the directorate general of foreign trade, India, for shipping of samples abroad.

Lack of investigator Continued GCP training of study awareness (protocol recommended and ICD)

Action taken by IEC

After monitoring the sites, the teams presented their reports at the next IEC meeting. After the presentation of each report, the findings of monitoring visits were conveyed in writing to the PIs with a request to demonstrate compliance within a specified time. The compliance report was again presented to the IEC and recommendations were given to the PIs. If the PI was found to have deviated from the investigational plan frequently, the IEC put temporary (till PIs gave evidence of taking recommended corrective actions like training of staff ) restrictions on further recruitment. In case of protocol violation and lack of reporting of study progress, the IEC asked for an explanation, with a clear warning not to repeat the violation in future and ensured that corrective actions were implemented. Additional AE reports were asked for from investigators who had failed to submit them in time. For the SAEs not reported earlier, follow-up reports and outcome were called for from the PIs and reviewed. Continued GCP training of all investigators was made compulsory and PIs were asked to submit a copy of the certificate at the time of submission of a new project. Moreover, in certain studies where it was felt that patients safety and wellbeing were compromised, IECs asked for monitoring reports from the sponsors and the recommendations of the data safety monitoring board, if relevant. At sites with inadequate study supervision, the IEC advised recruitment of additional GCP trained members in the study team. It was recommended that at least one study coordinator per trial be appointed. In many investigator-initiated studies, resident doctors were the PIs, so the IEC recommended the

Discussion The site monitoring visits carried out by the IECs of a tertiary care hospital in India revealed innumerable protocol violations, which would not otherwise have been identified. The findings relating to violations of the informed consent process were particularly disturbing as they violated the basic principle of autonomy, a fact that needs to be viewed seriously. There were discrepancies between the consent forms approved by the IEC and the forms used at the site; in some cases, ICDs, or the signatures of patients and /or PIs were missing. These violations were similar to thoseobservedinthestudiescarriedoutbyMcCusker et al(8), in which an audit of 188 consent forms of 33 protocols revealed that consent forms were missing from the site, non-approved consent forms had been used, and the signatures of participants, witnesses and investigator were found missing in many forms. Another study by Smith et al (9) in 1997 showed that, of the 39 projects reviewed; a quarter had protocol deviations in relation to the consent process. The same study had found that, though adverse events had been reported, projects which were abandoned or late to start were vastly underreported to the IEC (9). In our study, delayed reporting of serious adverse events was a common finding.

Qualitative interviews with investigators for 16 research projects conducted by Douglass et al (10) concluded that an active monitoring programme can detect deviations from the approved protocol not disclosed in the annual report. The same was observed in our study during the interviews with the PIs. An encouraging finding in our study was that the

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patients understanding of the research study, including the benefits and risks involved, was adequate. It was therefore felt that most of the protocol violations, including those related to the ICD, were due to an overload of clinical work rather than the unethical behaviour of the PI. The results of this study reveal that there is an urgent need for an active monitoring programme by IECs for the continuing review of ongoing projects. Currently, lack of infrastructure, manpower, funds and time is a major hurdle for conducting active site monitoring. Most IECs spend a substantial amount of time in reviewing and approving protocols and reserve some
Appendix1: Site monitoring visit report

time for passive monitoring, ie, reviewing SAE reports, periodic status reports, etc. There is very little time left to carry out site monitoring. Another aspect is the lack of training. IEC members are not trained to conduct monitoring. In India, there is no central body which offers accreditation, trains IEC members to monitor studies, and monitors IECs for their compliance. In the studies by Demets and Weijer (5, 11) the authors have discussed the problems involved in carrying out continuing review by IECs. Smith et al (9) have reported that each detailed review takes six person hours at a cost of 120.

Is it approved by the IEC? o Yes o No

Comment:

No. of participants approved at site by IEC: ______ Total participants recruited since protocol began: ______ New participants recruited since last year:

Any adverse event found? o Yes o No Any SAEs found?

Comment: Comment:

No. of patients screened: ____ No. of patients enrolled: ____ No. of patients completed: ____ No. of patients ongoing: ____ No. of patient drop-outs: ____ No. of patients who withdrew consent: ____ (State reasons)

o Yes o No Was the IEC informed about SAEs within 7 Comment: working days? o Yes o No Has any death occurred? Comment:

o Yes o No Was the IEC informed about this death within 24 Comment: hrs? o Yes o No Any protocol non-compliance /violation? o Yes o No Are all case record forms up to date? Comment: Comment:

No. of patients withdrawn by PI: ____ (State reasons)

Are site facilities appropriate?

Comment:

o Yes o No Are informed consents of recent version Comment: used? o Yes o No Is it approved by the IEC? o Yes o No Whether consent has been taken from all patients? o Yes o No Whether appropriate vernacular consent Comment: has been taken? o Yes o No Are protocols of recent version used? o Yes o No
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o Yes o No Are storage of data and investigating products Comment: locked? o Yes o No Are necessary life-saving present at the site? equipments/drugs Comment:

Comment: Comment:

o Yes o No Are the site personnel adequate? o Yes o No How well are participants protected? o Good o Fair o Not good Any other relative observations : Comments of the monitor Duration of visit: .hours Starting from: Name of IEC/ Independent Monitor Completed by:

Comment: Comment:

Comment:

Finish: Date:

Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

The need for recognition and affiliation of IRBs is currently not mandatory in India and depends, not only on the enthusiasm and motivation of an IEC, but also on the funds that it receives. Many IECs in India do not receive sufficient funding and the institutes in which they are situated are not keen to provide funding on a priority basis. IECs therefore continue to struggle to meet the responsibility of accreditation, continued training, and staffing. Active on-site monitoring helped our IEC to identify problems related to the implementation of GCP which could not have been detected by the passive ongoing review of study-related documents carried out routinely by our IECs. Thus IECs need to have mechanisms for site monitoring in place so as to ensure that GCP is followed in letter as well as spirit. Declaration: No competing interests nor funding from any external agency to be declared.
references 1. Indian Council of Medical Research. Ethical guidelines for biomedical research in human participants[Internet]. New Delhi:ICMR;2006 [cited 2011 Nov 9].p.111. Available from: http://www.icmr.nic.in/ethical_ guidelines.pdf

Ministry of Health and Family Welfare, Department of Health. Drugs and Cosmetics (II amendment) rules, 2005 [Internet]. New Delhi: Government of India; 2005 Jan 20 [cited 2011 Nov 23]. Available from: http:// dbtbiosafety.nic.in/act/Schedule_Y.pdf 3. World Health Organisation. Operational guidelines for ethics committees that review biomedical research [Internet]. Geneva:WHO;2000[cited 2011 Mar 26]. Available from: www.who.int/tdr/publications/publications/ 4. Pickworth E. Should local research ethics committees monitor research they have approved? J Med Ethics. 2000 Oct 26; 26(5):3303. 5. DeMets DL, Fost N, Powers M. An institutional review board dilemma: responsible for safety monitoring but not in control. Clin Trials. 2006;3(2):142-8. 6. Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA. 2001 Mar 7;285(9):1201-5. 7. Ethics committee for research on human subjects. Seth GS Medical College and KEM Hospital, Mumbai. Site monitoring visit [Intranet] 2009 Jun 26[cited 2011 Nov 11]. Available from: www.kem.edu/dept/ ethicscommittee/SOP15.PDF 8. McCusker J, Kruszewski Z, Lacey B, Schiff B. Monitoring clinical research: report of one hospitals experience. CMAJ. 2001 May 1;164(9):1321-5. 9. Smith T, Moore EJH, Tunstall-Pedoe H. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients case notes, consent forms, and research records and by interview. BMJ. 1997 May 31;314:1588-90. 10. Douglass AJ, Jarvis A, Bloore S. Monitoring of health research by research ethics committees. N Z Med J. 1998 Mar 13;111(1061):79-81. 11. Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation unfulfilled. CMAJ. 1995;152(12):1973-80.

2.

Thank you, reviewers All submissions to the journal undergo extensive review by internal reviewers from within the journals editorial boards as well as by external peer reviewers. We would like to thank all our editorial and advisory board reviewers, and also name the following external experts who have reviewed articles for the journal during 2011: Aamir Jafarey, Akash Bang, Akoijam Joy, Amita Dhanda, Amita Pitre, Anant Bhan, Anant Phadke, Anirudh Kala, Anoop Thekkuveetil, Bhushan Shukla, C Adithan, Chinu Srinivasan, David Thambu, Devadasan, Dhanwanti Nayak, Gagandeep Kang, Gopal Dabhade, Indu PS, J Divatia, Joe Varghese, Kajal Bhardwaj, Kalpana Kannabiran, Laxmi Murthy, Leela Visaria, Leigh Turner, MR Hariharan Nair, Nalini Rao, Nandini Kumar, Nithya Gogtay, Prabir Chatterjee, Premila Lee, Rajeev Kumar, Rakesh Aggarwal, Ramakumar, Raman Kutty, Ravi Duggal, Ravindra RP, Renu Addlakha, SP Kalantri, S Srinivasan, Samiran Nundy, Shailaja Tetali, Soumitra Pathare, Sridhar S, Subha Sri, Suneeta Krishnan, Sunita Bandewar, Sunita Simon Kurpad, VR Joshi, Vineesh Mathur.

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CoMMents

Finding and using evidence that you can trust

PrATHAP THArYAN
Professor of Psychiatry, Director, South Asian Cochrane Network and Centre, Professor BV Moses and ICMr Centre for Advanced research in Evidence-Informed Healthcare, Christian Medical College, Vellore 632 002, Tamil Nadu INDIA e-mail: prathap@cmcvellore.ac.in

Abstract
Much of the evidence-base from research is biased. Systematically assembled, quality-appraised, and appropriately summarised reviews of the effects of interventions from all relevant intervention studies are needed, in order to use research evidence to reliably inform health decisions. The Cochrane Library is an online collection of six searchable, up-to-date, evidence-based databases that is available free to access by anyone in India, thanks to a national subscription purchased by the Indian Council of Medical Research. This valuable resource contains the worlds single largest collection of systematic reviews and controlled clinical trials, as well as bibliographic details and records of methodological research, health technology assessments and economic analyses. The robust and transparent methods pioneered and used in Cochrane systematic reviews, and independence from industry funding facilitate the detection of biased, deceptive and fraudulent research, and have earned these reviews the reputation of being trusted sources of evidence to inform health decisions. Cochrane reviews have had considerable impact on academic medicine; have informed health practices, policies and guidelines; improved health outcomes; and saved numerous lives. An editorial in the previous issue of this journal summarised the results of empirical research revealing that much of the evidence from research that is integral to the practice of evidence-based medicine cannot be trusted(1). This does not mean that none of the evidence can be trusted. However, it does require a special effort to identify sources of reliable evidence, to understand how this should be assessed, and the amount of confidence one can place in this evidence.

The least biased evidence that addresses these issues regarding the effects of interventions comes from wellconducted systematic reviews and meta-analyses of all RCTs conducted that compare an intervention to no intervention (or placebo), and to other interventions commonly used for that health condition. If RCTs are not ethical, practical, or feasible, then systematic reviews of particular types of well-conducted observational studies could provide alternative sources of evidence. Systematic reviews use explicit and systematic methods to search for, locate, and retrieve; critically appraise for the risk of bias; reliably extract and analyse data from all relevant research studies addressing a focused clinical question, and summarise the overall results. They, therefore, provide information that individual trials cannot. Many systematic reviews, though not all, synthesise their results using meta-analyses. Meta-analysis is the statistical technique that aggregates the numerical data for each relevant outcome from the primary studies that are sufficiently similar in their participants, interventions, methods, and outcomes to combine in a clinically meaningful manner. Systematic reviews in the Cochrane Database of Systematic Reviews (CDSR), one of six evidence-based databases that form part of The Cochrane Library (www.thecochranelibrary.com), are particularly reliable sources of evidence, as are systematic reviews that use the methods pioneered by the Cochrane Collaboration (www.cochrane.org). The resources in The Cochrane Library are free to access by anyone in India with a computer and an internet connection, thanks to a national subscription purchased by the Indian Council of Medical Research (ICMR) since 2007, and renewed for a further three years in 2010. More than half the worlds population also has free access to this valuable resource due to various sponsored initiatives or licensing agreements(5).

Finding the right evidence

The first step in evidence-informed healthcare is to find relevant evidence that is free of the risk of bias. Randomised controlled trials (RCTs) are considered the type of study design that is least likely to provide biased estimates when assessing the effects of interventions. However, the language of research facilitates deception, through the use of descriptive terms that are widely employed to describe studies that have not necessarily used, or used adequately, the methods required to provide Gold Standard evidence that RCTs are assumed to provide (2-4). Moreover, the results of a single RCT are unlikely to be generalisable to all situations where the intervention may be used. The results of different RCTs of the same intervention and control comparison may also differ substantially.

The impact of Cochrane systematic reviews

Only about 20% of reviews published each year are Cochrane systematic reviews. However, empirical research reveals that Cochrane systematic reviews are scientifically more rigourous, more likely to be up to date, and less biased in their methods and interpretation than non-Cochrane systematic reviews (6, 7). The 2010 impact factor for the CDSR was 6.186. The CDSR is now ranked in the top 10 of the 151 journals in the medicine, general, and internal category, and receives the seventh highest number of citations in its category.

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Other more important examples of the impact of Cochrane reviews include informing the guidelines of many agencies, including those of the World Health Organisation, and influencing global, national and regional health policies. Cochrane reviews in many topic areas have provided clinicians, patients and their care-givers access to reliable evidence that have improved health outcomes and saved numerous lives.

more likely to show statistically significant results; be published in high-impact, mostly English-language journals; be sponsored by the pharmaceutical industry and, be published sooner than unpublished studies (17, 18). If one were to rely only on the results of these published trials, without balancing the evidence from unpublished trials (often smaller and with negative or inconclusive results), one would be seriously misled(19). Hence, apart from searching different online databases, Cochrane reviews routinely search the Cochrane Central Register of Controlled Clinical Trials (CENTRAL), the worlds largest repository of information regarding clinical trials that forms part of The Cochrane Library. It includes details of published articles taken from multiple bibliographic databases, other published resources, and from unpublished sources. Cochrane reviews also routinely search the specialised registers of the respective collaborative review groups supporting the review. Experts in the field and drug manufacturers are contacted for further, often unpublished, information, as well as the authors of identified studies; and the cross references of these studies are searched for further references. Clinical trials registries are also searched for on-going trials. No language restrictions are applied in the search strategy in order to avoid language bias; regional databases are also searched, and retrieved reports are translated, if needed. 4. Minimising biases in the review process: The review teams are assembled to balance the views of all authors and to avoid financial and academic conflicts.Bias in selecting trials is minimised in Cochrane reviews by involving at least two authors who independently apply pre-stated, explicit inclusion and exclusion criteria. They also independently assess quality; extract data and contribute to writing the results and discussion. Disagreements are resolved by discussion or contacting authors of trials. Inputs are provided from two editors, a lay reviewer and peer reviewers. Excluded studies are listed with reasons for exclusion; studies awaiting assessment are also listed, and ongoing trials are described. Any changes between the published protocol and the final review are documented, discussed, and justified. Authors are supported by editorial teams from conception, through development, completion, and publication of the review, and upto updating of the review, ideally every two years, or when new trials are located or published. 5. Minimising conflicts of interest: The Cochrane Collaborations polices prohibit industry funding of review teams or collaborative review groups and methods groups earning Cochrane reviews the reputation of being independent sources of reliable evidence. 6. Assessing the risk of bias in included studies: Including studies at high risk of bias that are likely to have erroneous effect estimates, are unpredictable in magnitude and direction (20), will result in systematic reviews with misleading results. Hence, RCTs are preferred in most Cochrane reviews. Quasi-randomised (where allocation to treatments can be predicted) and non-randomised trials are usually not

Why are Cochrane systematic reviews and metaanalyses regarded as reliable sources of evidence?
The major reasons that contribute to the reliability of Cochrane systematic reviews stem from the rigourous methods used in their preparation. These methods are described in the Cochrane Handbook for Systematic Reviews of Interventions (www.cochrane-handbook.org). They include: 1. Transparent, reproducible methods: Systematic reviews commence with a methods section or protocol that is unusual in traditional review articles. Protocols of Cochrane systematic reviews are peer-reviewed, editorially vetted and published online in the CDSR before the review commences. The protocol outlines in detail the scope and methods planned for undertaking the review. 2. Striving for relevance: The topics selected for Cochrane systematic reviews are agreed in advance by the authors and editorial team as relevant to health care, and are often selected in response to the expressed needs of relevant stakeholders. Cochrane review topics cover not only pharmacological interventions but a variety of nonpharmacological interventions and aspects of health-service delivery. The pre-stated primary outcomes in Cochrane reviews may not be the primary outcomes used in the included trials. Thus, the primary outcome of a systematic review that compared reduced osmolality oral rehydration solution (ORS) versus the WHO-recommended, standard ORS to treat acute dehydration due to diarrhoea in children, was the frequency of unscheduled intravenous saline infusions used. This was considered by the review team as a real-world indicator of the failure of either solution to effectively treat diarrhoea (8). This was not a primary efficacy outcome in most of the 11 included trials and was obtained not from the description of the main results or tables, but from elsewhere in the paper; in three other included trials, it was not reported. In this review, reduced osmolality ORS required significantly fewer unscheduled intravenous saline infusions than standard ORS, and is now the recommended standard. Many other examples exist where Cochrane reviews have challenged the received wisdom and changed established practices and health policy by demonstrating that interventions in common use were ineffective(9-13) or even harmful(14-16). 3. Comprehensive search strategy: Systematic reviews attempt to locate all relevant studies that have addressed the reviews objectives, and not only a biased sub-set of published studies, or ones that were easily available. Empirical research has demonstrated that studies published in journals are

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included, if RCTs were thought feasible for the intervention(s) reviewed. In addition, all Cochrane reviews assess each included primary study for the risk of bias across six dimensions empirically shown to influence outcomes. They are: generation of the randomisation sequence; concealment of allocation; blinding (often assessed separately for subjectively reported outcomes, where lack of blinding could introduce bias; and for objectively ascertained outcomes, where lack of blinding usually does not introduce bias); incomplete outcome reporting (again often assessed separately for efficacy measures; and for harms that are less often reported adequately); selective reporting; and other biases such as conflicts of interest. Many non-Cochrane reviews either do not routinely evaluate the risk of bias, or use unreliable quality scales to assess study quality(6).These methods used in Cochrane systematic reviews also facilitate the detection of scientific misconduct, misinformation, and redundant publications (21). 7. Pooling the results of trials instead of counting votes: A metaanalysis averages the results of individual trials that provided data for the proportions of participants randomised to the intervention versus the comparison that experience a particular outcome. This is done in order to provide a pooled common estimate of relative effects. The results of the individual trials are commonly expressed as risk ratios (RR) or odds ratios, along with their 95% confidence intervals (CI)(22).For the pooled effect estimate in a meta-analysis, each trial is proportionately weighted so that larger trials, and trials where more people experienced the outcome of interest, particularly with the control intervention or comparison arm (indicating a high baseline risk of developing the outcome), are given more weight in the pooled estimate. The proportionate weight assigned to each trial is the inverse of its variance (a measure that combines the two parameters described above and indicates more precise estimates of the likely range of results). Thus trials that provide more information with more precise results get more weight in the pooled results of all the trials. This is instinctively more appealing than counting the number of trials where the result favoured the intervention over the comparison, versus the number of trials where the reverse occurred, or where the results were inconclusive. In this traditionally used vote-counting method, the results of a large trial and a small trial would each be counted as one for and one against the intervention being effective. An example is provided in Figure 1 that displays a (fictitious) meta-analysis (or forest plot) comparing drug A with drug B for the treatment of obesity. The outcome assessed in the figure is the risk of death. In this hypothetical example, the five trials (identified in the rows in column 1 by the last name of the first author and year of publication) included in the meta-analysis randomised 930 adults to anti-obesity drug A, of whom 51 died, (columns two and three), and 928 adults to antiobesity drug B, of whom 72 died (columns three and four). The variance in the trial by Pai 2010 was the least since it
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provided the most information (largest sample size and most deaths) and had the most precise results (narrow confidence intervals), and hence is assigned the most weight (66.6%)(column four) in the meta-analysis. Jessani 2005 had the next largest sample size and next highest number of deaths, but gets the least weight (6.9%) since it had the least deaths in the control group (drug B), and the least precise results. The rows in the sixth column display the numerical values of the relative (RR) and 95% CI for the comparisons from each trial (without differential weighting). This is also graphically displayed in the last column as a forest of horizontal lines (hence the name forest plot; if there were many more trials, the resemblance to a forest of lines would be even more apparent) scattered around the vertical line that touches the base of the plot at the RR of 1(no significant difference). The rectangular blob in the middle of the horizontal lines represents the RR estimate for each trial. The size of the blob is proportionate to the weight assigned to each trial. The width of the horizontal lines depicts the upper and lower limits of the 95% confidence intervals. The pooled results of the five trials (proportionately weighted in the formula used for the meta-analysis to yield the weighted average) are provided in the last row. The pooled RR is 0.70 [95% CI 0.50 -0.99], and represents the average risk of death with drug A compared to drug B. The diamond at the bottom of the graph in the last column includes the pooled RR and confidence limits of the five trials. The lower limit of the pooled 95% CI in the diamond [RR = 0.99] stops short of touching the vertical line [RR = 1]. 8. Ensuring the results are statistically significant and clinically important: In conventional terms, these results are statistically significant as the p value is < 0.05 (The last row in the forest plot tests the overall effects and reveals the actual p value to be 0.04; indicating that one can be 96% certain that the difference in the effects of the two drugs is not due to chance). From a clinical perspective, an RR of 0.70 means that drug A reduces the risk of death by 30%, and while we think this is the actual estimate of relative risk reduction (RRR), the upper and lower limits of the CI of the estimate suggests that the risk of death could be reduced by as much as 50%, or as little as 1%. If the higher estimate were true, this would be even better than what we think the estimate is, but if it were the lower estimate, then the clinical usefulness of drug A over drug B in averting 1% fewer deaths is less encouraging, given that 51 (6%) of people given drug A in the five trials died versus 72 (8%) with drug B; unacceptably high rates of death with both drugs. If one evaluated the actual number of deaths averted with drug A (51/930) compared to drug B (72/928), the Absolute Risk Difference (ARR) is 0.0227; 95% CI 0.0001-0.0457. This indicates that drug A averted just two deaths out of 1000 people treated compared to 1000 people given drug B; and this could be as few as 1/1000 treated or as many as 5/1000 treated, again not very impressive achievements. This example highlights the importance of evaluating

Indian Journal of Medical Ethics Vol IX No 1 January-March 2012

effect sizes such as the RR and 95% CI, rather than only rely on p values <0.05 to denote that the differences in the results are significant. The p value will continue to be <0.05, even if the RR was 0.30, 95% CI 0.20 0.40; a result that is both statistically significant (both limits of the CI < 1), and clinically important (we estimate that drug A would reduce the risk of death by 70%, though it could be as low as 60% or as much as 80%). This example also emphasises the need to examine the absolute effects to understand the true benefits and harms of interventions, in addition to the more impressive relative estimates of effects. 9. Detecting, quantifying, and explaining inconsistency in the results across studies: An oft-repeated criticism of metaanalysis is that combining the results of dissimilar trials is akin to mixing apples and oranges and is likely to yield no meaningful results (unless one is interested in fruitsalad!). If the effects are virtually identical in all trials in the meta-analysis, then confidence in the pooled weighted summary estimate as representing the average effect of the intervention versus the control is strengthened. If there is inconsistency in the direction, magnitude and precision of the effect estimates in meta-analyses, suggesting the intervention worked better in some trials than in others, confidence that the pooled estimate accurately describes the average effect of the intervention is diminished. Clinical heterogeneity; Clinical heterogeneity arises from differences in the clinical aspects of trials. Trials carried out in different countries; in different years or even decades; on different populations; with different definitions and thresholds for diagnosis; and varying grades of severity of the health condition; are likely to yield results that differ considerably. Similarly trials using interventions that differ in doses, formulations, combinations, routes, regimens, and durations of treatment; and comparing them with placebo or no treatment, and a myriad of alternative treatments with the same dizzying array of variations, will also yield differing results. Trials that use outcomes that are defined, and ascertained in different ways, and at different timepoints will add to the possibility of yielding results that are inconsistent in a meta-analysis. Trials in meta-analyses whose methods increase the risk of bias often differ in their results from those at low risk of bias, resulting in methodological heterogeneity. Finally the results may be inconsistent purely by chance. Clinical and methodological reasons for heterogeneity can result in statistical heterogeneity that is not uncommon. What is important is to identify if observed inconsistency in the results is due to chance (random error), and to what extent important differences in the trials contribute to the inconsistency. This will help determine if the results of the individual trials can be still be pooled and presented as an average, or fixed effect, of the intervention across all the trials (hence the use of the term fixed effect meta-analysis in the figure legend and at the top of the last column). However, if one inspects the graphical display of results in Figure 1, it is easily apparent that in Jessani 2005, the RR
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of 5.60; 95% CI 2.27 13.81 indicates that drug B was far more effective than drug A; a result that is in the opposite direction to the RR estimates of the other four trials. In the graphical display and the numerical description, the confidence limits in Jessani 2005 also clearly do not overlap with those of the other trials. Non-overlapping confidence intervals, especially if accompanied by effect estimates that differ in the direction of effects, are clear indications that the results from all the trials included in the metaanalysis are inconsistent with the pooled result, raising the possibility of statistical heterogeneity. It is possible (though unlikely given the clear difference in the direction of effects) that this inconsistency in results is due to chance. The chisquare test for homogeneity shown in the second last row reveals a very small p value, indicating that one can be 99.99999% sure that this inconsistency is not due to chance but due to differences in the trials (clinical or methodological heterogeneity). Just as with the previous example, the p value from the chi-square test only provides us the certainty of excluding chance as an explanation of a result, and does not reveal how much of this inconsistency is actually important. The final notation in the second last row of the figure reveals an I2 value of 87%. The I2statistic is derived from the chisquare test and reinterprets this to indicate the proportion of inconsistency that is due to true heterogeneity in the trials. The I2value of 87% indicates that only 13% of the inconsistency observed is due to chance and 87% is due to differences in the way the drug works in the trials. This degree of inconsistency is too large to ignore; and it would be unreasonable to assume that the pooled effect estimates provide a realistic average effect of drug A. Had this value been less than 25%, one might be less worried about heterogeneity in the meta-analysis since more than 75% of the differences in results of the five trials occurred by chance. 10.Explaining heterogeneity: It is assumed that combining the results of different studies is likely to result in heterogeneity, should the trials differ significantly in clinical characteristics and methods. Review authors, therefore attempt to ensure that the trials in a meta-analysis are sufficiently similar in their methods, participants, interventions and outcomes to meaningfully combine. Cochrane review protocols also prespecify ways in which the reasons for heterogeneity would be explored, should the above tests indicate the presence of substantial inconsistency in results not accounted for by chance [I2>50%]. One method of exploring inconsistency is to pre-specify a limited number of subgroups, based on features of the participants, interventions, comparisons, outcomes, or the methods used that could explain why drug A might work better than drug B in some trials and not in others that did not share these features. For example, let us assume that the review authors had prespecified that if substantial heterogeneity was detected, the trials would be sub-grouped by the presence of pre-existing risk factors for cardiac disease in participants. If Jessani 2005

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had included many participants with previous episodes of angina or cardiac disease who were on medications, while the other trials had excluded such participants, the sub-group analysis of the forest plot would look different (Figure 2). The meta-analysis now shows that the pooled results in the subgroup of trials where participants had no cardiac risk factors, drug A was far more effective than drug B in reducing the risk of death. There is no inconsistency in the results within this subgroup of trials [I2 = 0%]. Death was more likely with drug A than drug B for those with previous angina on medications, and this could be due to the heart condition and / or to medication interactions. It would be meaningless to pool the results of the five trials now in the face of such substantial heterogeneity, and significant differences in effect estimates in the sub-groups. However,

the inconsistency in the pooled results of the five trials helped us in understanding the differential effects of drugs A and B in those with cardiac risk factors that would not have been so apparent from the results of a single trial.

Conclusions
These and other methods described in detail in the Cochrane Handbook, ensure that the results of Cochrane systematic reviews are robust and reliable. However, the numerical results alone may be insufficient to inspire confidence in the effects of the intervention, or to require a change in practice. Systematic reviews differ in the numbers of included trials that met inclusion criteria, or that provided data for each outcome in the reviews. They also differ in the risk of bias in the included studies; and even in those that contributed data for different outcomes within a review. Two systematic reviews

Figure 1: Forest plot depicting a meta-analysis of a (hypothetical) comparison of two anti-obesity drugs: Outcome: death during treatment (Fixed effect meta-analysis)

Figure 2: Forest plot depicting a meta-analysis of a (hypothetical) comparison of two anti-obesity drugs: Outcome: death during treatment subgrouped by cardiac risk factors (Fixed effect meta-analysis)
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addressing the same question may yield different conclusions and differ in the way they selected outcomes and defined outcome thresholds. A systematic review may conclude that drug A is recommended; and another systematic review may subsequently conclude that the drug is harmful, due to hitherto undisclosed adverse effects. The review may find that drug A causes fewer deaths than drug B but is less effective in treating obesity. Future comments in this journal will describe methods of integrating the numerical results with other important information when summarising the results of meta-analyses in systematic reviews, so that one can understand how much confidence to place in the overall evidence provided to reliably inform health decisions. Competing interests The author is a contributor to the Cochrane Collaboration (www.cochrane.org) and director of one of the 14 independent Cochrane Centres (www.cochrane-sacn.org) worldwide. He has received research funding, travel support, and hospitality from organisations that support evidence-based healthcare. Funding support The author is a salaried employee of the Christian Medical College, Vellore. Declaration This article has not been previously published or submitted for publication elsewhere
references 1. 2. 3. Tharyan P. Evidence-based medicine: can the evidence be trusted? Indian J Med Ethics. 2011;8(4):201-7. Wu T, Li Y, Bian Z, Liu G, Moher D. Randomized trials published in some Chinese journals: how many are randomised? Trials. 2009;10:46. Zhang D, Freemantle N, Cheng KK. Are randomised trials conducted in China or India biased? A comparative empirical analysis. J Clin Epidemiol. 2011 Jan;64(1):90-5. Tharyan P, Premkumar TS, Mathew V, Barnabas JP, Manuelraj. Editorial policy and the reporting of randomized controlled trials: a survey of instructions for authors and assessment of trial reports in Indian medical journals (2004-05). Natl Med J India. 2008 Mar-Apr;21(2):62-8. Tharyan P. Evidence of the people, by the people, and for the people. Cochrane Database Syst Rev. 2010;8:ED000013.

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Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiology and reporting characteristics of systematic reviews. PLoS Med. 2007 Mar 27;4(3):e78. Tricco AC,Tetzlaff J, Pham B, Brehaut J, Moher D. Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: crosssectional study. J Clin Epidemiol. 2009 Apr;62(4):380-6 e1. Hahn S, Kim S, Garner P. Reduced osmolarity oral rehydration solution for treating dehydration caused by acute diarrhoea in children. Cochrane Database Syst Rev. 2002(1):CD002847. Duley L, Henderson-Smart D. Magnesium sulphate versus phenytoin for eclampsia. Cochrane Database Syst Rev. 2003(4):CD000128. Duley L, Henderson-Smart D. Magnesium sulphate versus diazepam for eclampsia. Cochrane Database Syst Rev. 2003(4):CD000127. Enayati AA, Hemingway J, Garner P. Electronic mosquito repellents for preventing mosquito bites and malaria infection. Cochrane Database Syst Rev. 2007(2):CD005434. Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2007(4):CD003343. Galappaththy GN, Omari AA, Tharyan P. Primaquine for preventing relapses in people with Plasmodium vivax malaria. Cochrane Database Syst Rev. 2007(1):CD004389. Farquhar C, Marjoribanks J, Lethaby A, Suckling JA, Lamberts Q. Long term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2009(2):CD004143. Alderson P, Roberts I. Corticosteroids for acute traumatic brain injury. Cochrane Database Syst Rev. 2005(1):CD000196. Alderson P, Bunn F, Lefebvre C, Li WP, Li L, Roberts I, et al. Human albumin solution for resuscitation and volume expansion in critically ill patients. Cochrane Database Syst Rev. 2004(4):CD001208. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev. 2009(1):MR000006. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3(8):e3081. Nassir Ghaemi S, Shirzadi AA, Filkowski M. Publication bias and the pharmaceutical industry: the case of lamotrigine in bipolar disorder. Medscape J Med. 2008;10(9):211. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empir ical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995 Feb 1;273(5):408-12. Vlassov V, Groves T. The role of Cochrane Review authors in exposing research and publication misconduct. Cochrane Database Syst Rev. 2010;8:ED000015. Selvan MS, Subbian S, Cantor SB, Rodriguez A, Smith ML, Walsh GL. Ethics of transparency in research reports. Indian J Med Ethics. 2011;8(1):31-6.

Hunger, ethics and the right to food

SrIJIT MISHrA
Associate Professor, Indira Gandhi Institute of Development research, General AK Vaidya Marg, Goregaon (E), Mumbai 400 065 INDIA e-mail: srijit@igidr.ac.in

Abstract
The management of hunger has to look into the issues of availability, accessibility and adequacy of food supply. From an ethical perspective, this paper argues in favour of the right to food. But, for this to become viable, the state has to come up with an appropriate and effective bill on food and nutrition security, address the issue of inadequate provisioning of storage space by state agencies leading to rotting of food grains - a criminal waste when people are dying of hunger; and rely on local level institutions involving the community, that complement the administrative structure to identify the poor and reduce exclusion and inclusion errors.

Introduction
The problem of hunger arises, more often than not, not from the non-availability of food; but from the inaccessibility of the available food (1:1). Again, provisioning of food for the hungry is not just to ensure that people eat. It is also important to know how much, and what food, people eat - an adequate, balanced and nutritious diet is vital. The recent global food crisis brought into focus spiralling prices and some reduction in availability (2-3), but these cannot be separated from accessibility and nutritional adequacy (4-5). Bringing together these divergent issues is a challenge for economic thinking, public policy and ethics.

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It is in this context that this paper proposes to raise issues concerning the food security of vulnerable sections of the population, the crisis in Indian agriculture, inadequate storage and rotting of food grains procured by the public agencies, a national food security bill, updating of the poverty line for 2004-05 by the Planning Commission based on a new method, and some concomitant ethical challenges. The last will be an issue cutting across other themes, which needs some independent discussion focusing on the predicament of who should get the fruit to begin with.

Who should get the fruit?

There are three children who want a fruit, say an apple, which according to the old adage, if consumed every day will keep the doctor away. The first child, Kwo, has a special liking for the apple and enjoys eating it the most (the other two children accept this); the second child, Dhu, is the one who put in the effort into nurturing and tending the plant of which this is the first fruit (the other two children do not deny this); and the third child, Rae, is undernourished and without access to enough food (the other two concede that they are well supplied with food). Now the question is: who should get the fruit? This is similar to the situation indicated by Amartya Sen where three children were quarrelling over a flute the first child knew how to play it, the second child had made it and the third child did not have any amenities to engage with. A classic philosophical question with at least three possibilities the utilitarian position favouring the first child, the libertarian argument linking property rights with effort favouring the second child, and the egalitarian point of view favouring the third child (6). In different forums and discussions where the fruit question has been raised by this author, there has been a convergence of opinion in favour of Rae, the malnourished child, getting the fruit. This position seems to be egalitarian, but the agreement could have a different reasoning for different individuals. Some taking the philanthropic position of giving food to the needy, and others arguing from the rights perspective that every individual has a right to food. The latter differ from the former in stating that it is not a dole that is being given to the poor and needy out of sympathy; it is their right. A libertarian perspective could say that the person who put in the effort should own the fruit, has a property right, and should be compensated for this in some form. If the compensation has a public policy provisioning and the fruit is given to Rae then this does not contradict the right to food perspective. There are utilitarian arguments in favour of Kwo being given the apple, who then, gives some other food to Rae. This may not violate the right to food, but it could lead to Rae consuming some unhealthy food with adverse implications for bodily health. This, in a sense, still violates Raes right to food, with reference to health and nutrition. Independent of the health implications, compensation with some other food means that Rae will have to make do with a second-best preference, a compromise.

The argument in favour of Raes right to food can also be viewed from a Rawlsian difference principleperspective, that is, it should be of the greatest benefit to the least advantaged members of society (7: 42-3). This emanates from an original position where people are under a veil of ignorance , an abstract position where people representing different stakeholders come together to frame rules but they do not know which group they belong to, and hence, all of them agree to rules that are in line with the difference principle. . It is akin to the maxmin outcome of game theory where the players first find out the minimum possible value in each of the strategies then choose the strategy that gives the maximum from all these minimum values, which indicates that at least this much is assured. . However, the Rawlsian difference principle is much more than maxmin because it is based on mutuality and trust. More importantly, the difference principle is the concluding part of Rawls second principle of justice. It is preceded in priority by the first part which refers to fair equal opportunities for all to choose the most suitable person(s) to positions of power and authority. These are preceded by the first principle, which has an overarching priority and refers to equal liberties for all. A similar, but much more profound social thought echoes from Mahatma Gandhis talisman: when in doubt, recall the face of the most vulnerable person and contemplate the implications of your actions on that person and you will find your answers. This can be applied as a test for any intervention that one plans, public policy or otherwise. Its advantage over Rawls lies in two aspects. First, one need not be under a veil to be in the original position, one can be oneself. Second, one need not be in the realm of abstract thought, one can be grounded in practical reality. There will then be no doubt about Raes right to food.

Food security and vulnerability

India ranks 66th among 88 countries in the Global Hunger Index (GHI) of 2010 (8). GHI is a multidimensional measure using three equally weighted indicators-- the proportion of undernourished population for 2004-06, the proportion of underweight children below the age of five for 2003-08, and the mortality rate of children under-five for 2008. With a GHI value of 23.7 the situation is considered alarming for India. What is more, a similar calculation for 17 major states indicates that the situation is serious in four, alarming in 12, and extremely alarming in one (9: 16). More and more individuals are like Rae. This indicates the vital importance of the right to food. There are two points of concern in the calculation of undernourished population being based on 1800 kilocalorie as an adequate requirement. First, this seems to have emerged from the thinking that such people will receive state support under some social security arrangement, as in some Western societies, to meet their minimum food requirements; and that they do not have to put in hard labour. But, this norm will be seriously inadequate for those individuals whose occupation and other contingencies require greater energy intake, as is generally the case with the poor in many parts of the world.

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Second, even when one agrees with the norm, a more appropriate interpretation would be that it represents the proportion of underfed population; because besides deficiencies in energy, undernourishment also includes deficiencies in protein, vitamins and minerals, among other things (8: 9). Such an interpretation also fits in with the final index being a measure of hunger, not undernourishment. Even for the poor, the first priority would be to meet a minimum energy requirement to avoid starvation. But, once this is met, there are other priorities in life such as the educational requirements of children, or the immediate health needs of some family members that could take precedence over food and nutritional adequacy. But, shortfalls in adequate food and nutrition will have adverse long term implications on health that can also have an intergenerational impact: the poor health of the mother being translated into poor health of the child. Thus, not giving the fruit to Rae takes us beyond the domain of the right to food to issues of inequities in health and nutrition (10). The total cereal consumption for all deciles, excluding that of the lowest decile, has declined from 1972-73 to 2004-05 (11: 43). A closer look reveals that the decline has largely been for nutri-cereals (like bajra and jowar among others) across all decile groups, which in some sense have been replaced by rice and wheat for the lower decile groups. What could give the impression of a changing consumption pattern over time is actually an outcome of the larger agricultural policy following the green revolution, with an excessive focus on rice and wheat, to the neglect of other crops. This has also coincided with the poverty norm being linked with a calorie requirement or energy consumption. Thus, Raes right to food has to go beyond cereals and also include, among other things, fruits. Between the years 1972-73 and 2004-05, one also observes that energy consumption of the richest and the poorest deciles are converging, but a substantial gap still remains, with the energy consumption of the latter as a proportion of the former being 53 per cent in rural areas, and 56 per cent in urban areas, in 2004-05 (11: 44). While the positive relationship between energy intake and expenditure deciles is understandable from an income perspective, there is an ethical imperative because the energy requirement is likely to have an inverse relationship with expenditure deciles. Then again, the average food consumption does not capture the uncertainty that the poor face in terms of access to food, which could mean some days of starvation. Such a struggle for food on a daily basis will, most likely, exclude other things essential for the development of a healthy body and mind. The study further shows that the growth of per capita expenditure for the bottom five decile groups compared to the all India average is higher when 2004-05 is compared with 1972-73, but lower when it is compared with 1993-94 (11: 42). This means that the poorer groups have had relatively lower increments in recent years, also identified as a post-reforms period, where the economy has witnessed a higher growth path. Some of the other vulnerable populations (or those

identified with Rae) are lactating and pregnant mothers, children particularly the girl child- and school dropouts, the elderly, single and destitute women, those with ailments and physical disabilities, dalits and tribals, and the unemployed among others. Similarly, some sectors have not benefited as much as others have. One such sector is agriculture.

Crisis in Indian agriculture

Indian agriculture is undergoing a crisis that is manifested in twin dimensions agricultural and agrarian (12-13). The former is indicative of a developmental failure on account of poor public provisioning to the agricultural sector. This resulted in a deceleration in production and productivity of almost all crops in the 1990s (triennium ending (TE) 1994-95 to TE 200708) when compared to the 1980s (TE 1981-82 to TE 1993-94); the per annum growth rates in production during the 1990s for foodgrains, oilseeds and sugarcane at 1.1 per cent, 1.2 per cent and 1.4 per cent, respectively, being lower than the per annum population growth rate of 1.9 per cent for 1991-2001 (12: 4950) or 1.6 per cent for 2001-11, according to the latest census. The latter underlines the threat to the livelihood base of the mass of small and marginal farmers and agricultural labourers. The annual per capita availability of foodgrains has come down from 177 kilograms in TE 1992 to 159 kilograms in TE 2007. Using the norm of 2400 kilocalories per consumer unit (this is lower than per capita, as it adjusts for age and sex composition), the incidence of calorie poor in rural India is 43 per cent; it is even higher for the occupational group of agricultural labourers at 58 per cent and the land size group of marginal holding (0-1 hectare) households at 47 per cent (12: 54). A cruel irony is that those whose hands grow the nations food do not have enough to eat. Further, the nemesis of the Indian farmer has been poor returns on cultivation, which based on a nation-wide survey conducted during 2003, is less than eight rupees per person per day (14). To contextualise from our fruit analogy, this reflects the sorry predicament of Dhu. What is more, Dhus situation, like that of Rae, falls short of the adequate food and nutritional requirement. The farmers have been getting some relief with recent increases in minimum support prices for foodgrains. This, however, has brought into focus the need for proper storage and distribution of foodgrains.

rotting foodgrains
In recent times, the rotting of foodgrains in storage facilities of the Food Corporation of India (FCI) and other public agencies such as the Central and State Warehousing Corporations has received much attention. Between 1997 and 2007, 1.83 lakh tonnes of wheat, 6.33 lakh tonnes of rice, 2.20 lakh tonnes of paddy and 111 lakh tonnes of maize were damaged in different FCI godowns, revealed a right to information petition (15). The Supreme Court of India in an order also pointed out that: In a country where admittedly people are starving, it is a crime to waste even a single grain (16). It further advised that the Government take different steps including that of distributing

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the food to those who deserve it. This, in a sense, reflects Raes right to food, but more importantly, it underlines the states duty to fulfil that right. The Ministry of Consumer Affairs, Food and Public Distribution in a recent press release indicated that, as of 1 June 2011, the capacity of FCI and other public agencies to store grains is 623.65 lakh tonnes, of which 28.5 per cent (or 177.69 lakh tonnes) is under the open sky covered by a tarpaulin. What is worrying is that this combined capacity is only 95.3 per cent of the stocks at 654.73 lakh tonnes (17). A letter to the Supreme Court of India further highlights poor food grains management from two additional aspects (18). First, there are instances of storage of food grains under cover and plinth in the open for more than a year, exposing them to two or three monsoons and thereby rendering a substantial amount of it unfit for consumption. Second, the FCI let go of hired space because of adverse remarks from the Comptroller and Auditor General (CAG) and then could not hire back the same when the situation warranted. A parliamentary committee report on similar concerns begins by invoking the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights while reiterating the States obligation to ensure for everyone under its jurisdiction access to the minimum essential food which is sufficient, nutritionally adequate and safe to ensure their freedom from hunger (19: paragraph 1.1). The report goes on to suggest the need to construct additional storage spaces in a decentralised and time-bound manner without compromising on modern scientific technology, have more frequent physical verification of the stored food grains stocks, introduce the National Food Security Bill (NFSB) at an early date, and finalise the poverty estimates so as to help reduce exclusion and inclusion errors among others (19). The National Food Security Bill (NFSB) has been introduced in the ongoing winter session of parliament in 2011 and the Planning Commission has now accepted the new poverty estimates for 2004-05 suggested by an expert group that it had constituted. Both these issues need some further discussion.

the constitution and international covenants, but begins by stating that the bill will ... provide for food and nutritional security, in human life cycle approach, by ensuring access to adequate quantity of quality food at affordable prices (21). Thus, in a sense both agree to the relevance of nutrition in this exercise and one feels that this primacy should be explicitly mentioned in the title, which should read as the National Food and Nutrition Security Bill, 2011. At some point, the EGOM version refers to cash transfers in lieu of entitlement and leverages it with unique identification. Both these points have been under discussion in policy circles for quite some time and have a common origin. They are likely to do away with leakages and bring about effective targeting. The intentions are to address Raes right to food. But, they suffer from a common problem - they miss the real issue. Cash transfer is a money-centric approach that ignores the need to make food available where people need it. If food is made available and there exists an effective food grains distribution mechanism then cash transfer (if that is pegged to the real amount of food, note that this is different from being conditional to food purchases only) could make it accessible. Unique identification is a techno-centric approach to the real world problem of identifying individuals with food and nutritional insecurity. Independent of the issue of privacy under unique identification, which is equally important in a democratic polity, any technology for identifying people should be leveraged only after it is in place. This is not to belittle either the relevance of money or technology. They are very important, but as means and not as ends. One has to be cautious in the approach, otherwise exclusion and inclusion errors can take different forms and dimensions (22).

Counting the poor

An exclusion error is considered more serious than an inclusion error. This is particularly so in a welfare state, especially when the excluded person is well below the poverty line, whereas the included person is just slightly above that line. Then again, the norm used as a poverty line could refer to one aspect of vulnerability, whereas the intervention measure through public policy could be intended for something else. In India, food and nutrition interventions have taken different forms. Some of these are: the Integrated Child Development Scheme through Anganwadis for children below six years, and pregnant and lactating mothers, the Mid-day Meal (MDM) scheme for children going to government and governmentassisted primary schools, and the Targeted Public Distribution System (TPDS) under which below poverty line households receive food rations at a subsidised price through the fair price shops. Under TPDS it is essential to know the list of people below the poverty line. The Planning Commission has now accepted the recommendation of the expert group where the incidence of poverty is 41.8 per cent for rural areas and 25.7 per cent for urban areas in 2004-05 (23). While calculating this, the expert group did away with benchmarking the incidence of poverty

National Food Security Bill

A debate on the proposed NFSB has already been initiated in the press and other forums because of two versions - one that the National Advisory Council (NAC) has suggested (20), and another one that the Empowered Group of Ministers (EGOM) seeks to introduce (21). Both the versions have official sanction, and hence, it is good to see a discussion within the government itself. However, it is noteworthy that the NAC version also has the involvement of civil society, particularly a network of individuals and associations working jointly to implement the right to food. Some remarks on this are in order. The NAC version begins with a preamble, which ends indicating that ... a set of core entitlements within the universal right to food and nutrition are provided to be enjoyed and progressively expanded until universal access to adequate nutrition is achieved (20: 2). The EGOM does not have a preamble invoking

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with a calorie norm. The report of the expert group does mention that around the poverty line, people in urban India can afford the existing norm. But, their observed intake of 1776 kilocalories is closer to a norm of 1770 kilocalories indicated by the Food and Agriculture Organisation (FAO). If the latter is being used as a justification in support of the observed intake, then it misses the point that once basic hunger is satisfied, people will have other priorities that could compromise with food and nutrition security. It could be the education of children, the health care needs of family members, and social events (marriage, birth and death) among others; or, as in Adam Smiths England, the need to buy a pair of leather shoes so as to be able to go out without shame (24: V.2.148). It is another matter that the FAO norm is for light and sedentary activities and not for medium to heavy activities that the poor in India may be associated with. Thus, the claim that the new poverty line goes beyond calorie needs and incorporates the health care and education requirement is invalid (25-27). There are a few other concerns arising out of this new estimate. It uses median expenditure of health and education as a norm, which could be an underestimate because expenditure distribution is positively skewed (25, 28). It is not easy to replicate or to come up with comparable poverty lines for earlier years (29). Thus, time series analysis, beyond what is given in the report, is difficult. And, the acceptance of the poverty ratio for urban India from the old method as a starting point and then using it to compute a poverty line basket, has no other basis than the pragmatic consideration of starting from somewhere (30-31). More importantly, it changes the share of the poor across states, and if absolute numbers are not taken into consideration for increasing the budget, then poorer states will get lower amounts under some centrally sponsored poverty reduction schemes (32). As the estimates of the expert group are based on a sample survey of consumption expenditure from households, it cannot be used to identify poor households in the population. Before providing food or fruit, Rae needs to be identified. It is for this purpose that an independent census of below poverty line households in rural areas is underway in 2011. This should be an independent exercise. The incidence calculated using the national sample survey data cannot be imposed on the census data to limit the number of households which are poor, even if one allows a margin to address for some exigencies (33). This top-down approach may reduce the inclusion errors, but is also likely to increase the exclusion errors. What is required is a bottom-up approach, grounded in reality, to complement the top-down administrative structure and implementing mechanism. There is a strong case for involvement of the community at various levels, strengthening transparency to evaluate processes at every stage from policy formulation till the achievement of the policy objectives, and improving accountability (34-35).

compensating Dhu and providing for Rae, in which Kwo ends up with positive externalities, while both Dhu and Rae become better off. It satisfies Mahatma Gandhis talisman and Rawlsian fairness. The state should come up with an appropriate and effective bill on food and nutrition security, address the issue of rotting food grains -- a criminal waste when people still die of starvation-- and rely on bottom-up methods that complement the top-down administrative structure to identify the poor and reduce both exclusion and inclusion errors in targeting. Note The Draft National Food Security Bill, 2011, has now been put up for public scrutiny and is available from: http://fcamin.nic. in/dfpd_html/Draft_National_Food_Security_Bill.pdf. Conflict of interest: None. Acknowledgements: The author thanks the anonymous peer reviewer, Upasak Das, Sarthak Gaurav, GN Rao and VM Rao for their comments on earlier versions. The usual disclaimers apply.
references Sen A. Poverty and famines: an essay on entitlement and deprivation. Clarendon: Oxford University Press; 1981, p.xii+257. 2. Headey D, Fan S. Reflections on the global food crisis: How did it happen? How has it hurt? And how can we prevent the next one? [Internet]. Washington DC: International Food Policy Research Institute; 2010[cited 2011 Jul 25]. Available from: http://www.ifpri.org/sites/default/files/ publications/rr165.pdf 3. Naylor RL, Falcon WP. Food security in an era of economic volatility. Popul Dev Rev. [Internet]. 2010 Dec [cited 2011 Jul 25];36(4):693-723. Available from: http://iis-db.stanford.edu/pubs/23058/Volatility_final_12_10.pdf 4. Dev SM, Kadiyala S. Pro-nutrition agriculture in India: entry points and policy options. India Health Beat [Internet]. 2011 Jun[cited 2011 Sep 1];5(8):4p. Available from: http://www.phfi.org/images/pdf/Policy_ Note_Vol5_8.pdf 5. Dev SM. Rising food crisis and financial crisis in India: impact on women and children and ways of tackling the problem. Working Paper No. WP2011-003[Internet]. Mumbai: Indira Gandhi Institute of Development Research; 2011 Jan [cited 2011 Jul 25]. Available from: http://www.igidr. ac.in/pdf/publication/WP-2011-003. 6. Sen A. What do we want from a theory of justice? Journal of Philosophy. 2006 May; 103(5):215-38. 7. Rawls J. Justice as fairness: a restatement. Cambridge, Massachusetts: The Belknap Press; 2001, p.xx+214. 8. von Grebmer K, Ruel MT, Menon P, Nestorova B, Olofinbiyi T, Fritschel H, Yohannes Y, von Oppeln C, Towey O, Golden K, Thompson J. 2010 global hunger index, the challenge of hunger: focus on the crisis of child undernutrition[Internet]. Bonn:Welthungerhilfe, Washington D C: International Food Policy Research Institute, and Dublin: Concern Worldwide;2010[cited 2011 Jul 25]. Available from: http://www.ifpri. org/sites/default/files/publications/ghi10.pdf 9. Menon P, Deolalikar A, Bhaskar A. India state hunger index: comparison of hunger across states [Internet]. Washington DC: International Food Policy Research Institute, Bonn: Welthungerhilfe, and Riverside: University of California; 2009 [cited 2011 Jul 25]. Available from: http://www.ifpri.org/ sites/default/files/publications/ishi08.pdf 10. Sardeshpande N, Shukla A, Scott K, editors. Nutritional crisis in Maharashtra [Internet]. Pune: SATHI; 2009 [cited 2011 Sep1]. Available from: http://www.sathicehat.org/uploads/PastProjects/Nutritional_ Crisis_in_Maharashtra_Report.pdf 11. Suryanarayana MH. Food security: beyond the eleventh plan fiction. In: Nachane DM, editor. India Development Report 2011. New Delhi: Oxford University Press; 2011. p. 40-7. 12. Mishra S, Reddy DN. Persistence of crisis in Indian agriculture: need for technological and institutional alternatives. In: Nachane DM, editor. India development report 2011. New Delhi: Oxford University Press; 2011. p. 48-58. 1.

Conclusion
Any analysis of hunger has to take into consideration the availability, accessibility and adequacy of food among other conditions. In our fruit analogy, a win-win situation lies in

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13. Reddy DN, Mishra S, editors. Agrarian crisis in India. New Delhi: Oxford University Press; 2009. 14. Mishra S. Agrarian scenario in post-reform India: a story of distress, despair and death. Orissa Economic Journal- 2007-; 39(1&2): 53-84. 15. Indo-Asian News Service. Food grains rot in FCI godowns across India. The Hindustan Times, New Delhi. 2010 Jul 27 [cited 2011 Jul 25]. Available from: http://www.hindustantimes.com/Food-grains-rot-inFCI-godowns-across-India/Article1-578444.aspx 16. Supreme Court of India. Writ petition (civil) No. 196 of 2001. Peoples Union for Civil Liberties (petitioner) versus Union of India & ors. (respondents)[Internet]. 2010 Jul 27 [cited 2011 Jul 25]. Available from: http://www.sccommissioners.org/CourtOrders/Orders/TPDS_270710. pdf 17. Ministry of Consumer Affairs, Food and Public Distribution. Efforts being taken to create additional foodgrains storage capacity[Internet]. New Delhi: Press Information Bureau, Government of India. 2011 Jun 29 [cited 2011 Jul 25]. Available from: http://pib.nic.in/newsite/erelease. aspx?relid=72933 18. Saxena NC, Mander H. Report on the excess food grains in the godowns of the Food Corporation of India and the State Civil Supplies Corporations [letter][Internet]. Office of the Supreme Court Commissioners, in the case: PUCL Vs UOI and ORS. Writ Petition (Civil) No. 196 of 2001. 2010 Aug 10 [cited 2011 Jul 25]. Available from: http://sccommissioners.org/ Correspondence/ExcessGrain_100810.pdf 19. Standing Committee on Food, Consumer Affairs and Public Distribution (2009-10, Fifteenth Lok Sabha). Food subsidy and its utilisation. Eighth report [Internet]. New Delhi: Lok Sabha Secretariat; 2010 Aug [cited 2011 Jul 25]. Available from http://164.100.47.134/lsscommittee/Food,%20C onsumer%20Affairs%20&%20Public%20Distribution/Report.pdf 20. National Advisory Council. National Food Security Bill, 2011[Internet]. New Delhi: Government of India. 2011 Jul 7 [cited 2011 Jul 25]. Available from: http://nac.nic.in/foodsecurity/nfsb_final.pdf 21. Empowered Group of Ministers. National Food Security Bill, 2011[Internet]. 2011 Jul [cited 2011 Jul 25]. Available from: http://www.righttofoodindia. org/data/right_to_food_act_data/July_2011_egom_nfsb_draft.pdf 22. Cornia GA, Stewart F. Two errors of targeting. J Int Devel.[Internet]. 1993 Sep-Oct [cited 2011 Sep 1];5(5):459-96.Available from: http:// onlinelibrary.wiley.com/doi/10.1002/jid.3380050503/abstract 23. Government of India. Report of the expert group to review the methodology for estimation of poverty (Chairperson: SD Tendulkar) [Internet]. New Delhi: Planning Commission. 2009 [cited 2011 Jul 25]. Available from: http://planningcommission.nic.in/reports/genrep/rep_pov.pdf 24. Smith A.An inquiry into the nature and causes of wealth of nations[Internet]. Edwin Cannan, editor. London: Methuen & Co., Ltd. Library of Economics and Liberty. 1904 [cited 2011 Aug 29]. Available from: http://www. econlib.org/library/Smith/smWN21.html

25. Swaminathan M. The new poverty line: a methodology deeply flawed. Indian Journal of Human Development [Internet]. 2010[cited 2011 Sep 1]; 4(1):121-5. Available from: http://www.ihdindia.org/ihdjournal/ Abstract1.aspx?id=136 26. Shah G. The poor: beneficiaries to citizens. Indian Journal of Human Development [Internet]. 2010 [cited 2011 Sep 1];4(1):127-32. Available from: http://www.ihdindia.org/ihdjournal/Abstract1.aspx?id=137 27. Kannan KP. Estimating and identifying the poor in India. Indian Journal of Human Development [Internet].2010 [cited 2011 Sep 1]; 4(1):918. Available from: http://www.ihdindia.org/ihdjournal/Abstract1. aspx?id=134 28. Subramanian S. Identifying the income-poor: some controversies in India and elsewhere[Internet]. Discussion Paper, Courant Research Centre. 2010 Nov [cited 2011 Sep 1]. Available from: http://www2.vwl. wiso.uni-goettingen.de/courant-papers/CRC-PEG_DP_46.pdf 29. Raveendran G. New estimates of poverty in India: a critique of the Tendulkar committee report. Indian Journal of Human Development [Internet]. 2010[cited 2011 Sep 1];4(1):75-89. Available from: http:// www.ihdindia.org/ihdjournal/Abstract1.aspx?id=133 30. Alagh YK. The poverty debate in perspective: moving forward with the Tendulkar committee. Indian Journal of Human Development [Internet]. 2010[cited 2011 Sep1]; 4(1):33-44. Available from: http://www.ihdindia. org/ihdjournal/Abstract1.aspx?id=131 31. Datta KL. Index of poverty and deprivation in the context of inclusive growth. Indian Journal of Human Development[Internet]. 2010 [cited 2011 Sep1];4(1):45-73. Available from: http://www.ihdindia.org/ ihdjournal/Abstract1.aspx?id=132 32. Pathak DC, Mishra S. Poverty estimates in India: old and new methods, 2004-05[Internet]. Working Paper No. WP-2011-015. Mumbai: Indira Gandhi Institute of Development Research. 2011 Aug [cited 2011 Aug16]. Available from; http://www.igidr.ac.in/pdf/publication/WP2011-015.pdf 33. Breman J. A poor deal. Indian Journal of Human Development [Internet]. 2010[cited 2011 Sep 1]; 4(1):133-42. Available from: http://www.ihdindia. org/ihdjournal/Abstract1.aspx?id=138 34. Rao VM. Policy making in India for rural development: data base and indicators for transparency and accountability. Int J Economic Policy in Emerging Economies [Internet]. 2010 Sep [cited 2011 Sep1];3(3):222 36. Available from: http://inderscience.metapress.com/link. asp?id=u180x07562m105n5 35. Rao VM.Upward revision of the poverty line:some implications for poverty analysis and policies. Indian Journal of Human Development[Internet]. 2010 [cited 2011 Sep1];4(1):143-55. Available from: http://www.ihdindia. org/ihdjournal/Abstract1.aspx?id=139

Attempts at regulation of medical education by the MCI: issues of unethical and dubious practices for compliance by medical colleges and some possible solutions
ANANTHAKrISHNAN N1, SHANTHI AK 2
1 Director and Professor of Surgery (retired), Jawaharlal Institute of Postgraduate Medical Education and research (JIPMEr), Pondicherry 605 006 INDIA 2 Associate Professor of Paediatrics, Indira Gandhi Medical College and research Institute, Pondicherry 607 402 INDIA. Author for correspondence N Ananthakrishnan e-mail: n.ananthk@gmail.com

Introduction
There are, at present, over 335 medical colleges in the country conducting the MBBS course (1). Of these, well over 50 per cent are run by private organisations. Further, an overwhelming majority of institutions set up within the last two decades are privately run and not state sponsored. This itself indicates that governments, both central and state, do not have adequate

resources to invest for this purpose Many of these private institutions are managed by organisations and trusts which are recent entrants to the field and do not have a long history of experience in running educational institutions, leading one to suspect that altruism and a drive to promote education is not the sole factor guiding the start of these institutions. Medical education has become a promising and profitable business.

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The problems that plague medical education in the country are related to these twin facts: the mushrooming of medical colleges in the last two decades, and the shift of medical education from public to private hands. In 2009, there were 284 colleges listed on the Medical Council of India (MCI) website (2). This figure has risen over two years to 335. The problems and difficulties with ensuring quality in the medical education system in India, run across institutions and are not specific to any. The regulatory agency is aware of these issues and has often responded by what can be best be described as knee jerk reactions, without making serious attempts to correct the malady at its root. It is not surprising that these measures have little, if any, effect. Sometimes, the problems are worsened by these attempts. This paper will attempt to analyse the deficiencies in regulatory control of medical education in the country and the measures that are taken by individual institutions to beat the system and suggest possible solutions to cure the malady. If urgent measures are not instituted, the quality of physicians in the country in future will fall far short of the ideal. It must be emphasised that the problems listed here are not universal to all private institutions, and that many of the issues pertain to government institutions as well.

difficult to come by, since the monetary transaction is in cash and without a receipt, and parents / guardians are reluctant to testify since this would expose their wards to the wrath of the management. There are essentially two issues: lack of quality in admission and the matter of raising sufficient funds to run an institution and allow for profit. Running a medical college in the private sector is not mere philanthropy. It is a business like any other. Strict regulation of the fee structure and setting aside a large quota of seats for government-sponsored candidates, as happens in some states, compounds the issue. Since only a small pool is left to the managements of these institutions, abnormally high capitation fees are fixed for this group and quality becomes the casualty. In deemed universities, which are not compelled to give any quota to the government, these capitation fees can apply to all candidates. These issues can easily be resolved, provided there is a strong political will. During the tenure of the previous board of governors of the MCI, this matter was discussed in great depth in the working groups for undergraduate and postgraduate medical education, for well over a year. One of the recommendations made was that all admissions to medical colleges should take place through a single national entrance examination which takes into account the syllabi of all the +2 boards in the country. This entrance examination would be held two weeks after completion of the final year examination, before the start of internship. This change in scheduling was suggested since the existing system results in the whole one year-period of internship being spent by candidates in preparing for the entrance examination, without focusing on the acquisition of skills for which the internship is meant. A single national examination would also avoid the strain on candidates of having to apply and appear for multiple entrance examinations at several institutes / states. The national ranking list would comprise all candidates who have secured the minimum prescribed marks by the current guidelines and would also provide information on their states of nativity and eligibility for any reservation. This single national ranking examination would be used by all states, universities and institutions for their admission process. The existing reservation system would not be affected, since seats can still be filled up from the list by admitting students of the appropriate reserved category according to their ranking in the all-India merit list. The candidates can join their respective postgraduate courses on satisfactory completion of their internship by a process of counselling. In order to allow institutes to raise finance, 50% of the overall seats should be provided to the government for filling up the government quota with fixed fees and the remaining 50% should be free of any regulatory control on fees; provided the candidates are admitted from the national ranking list on merit. The government should ensure liberal conditions for these candidates to obtain loans from nationalised banks for their education. As regards the government quota, this should be legally ensured at the time of issue of the no-objection

Current problems
Absence of quality in admissions and high capitation fees These two issues are closely linked and must be dealt with together. The poor quality of many of the students admitted to private institutions is well known. This occurs because admissions to these institutions are linked, not to the merit of the candidates in a competitive examination, but to their ability to pay the capitation fees, which currently may run up to as much as Rs 40 lakh for the MBBS course in some colleges. Running medical colleges is an expensive proposition and the managements have to raise sufficient funds to do so. The fee structure fixed by the government is not realistic. The hospitals attached to the medical colleges often do not have enough patient intakes and do not make enough money to support the college for several years. Hence, colleges have to resort to alternative methods of collecting funds. The only solution that seems viable to them is to hike the fees to astronomical levels to allow for both sustenance and profit. Since entrance examinations are mandatory they are conducted, but the marks and the rank lists are not often displayed until the negotiations for admissions are complete. Since there is no strict monitoring of these entrance examinations, particularly in deemed universities, such a practice escapes detection. The fact of high capitation fees is well known and has been subjected periodically to exposs in the media and halfhearted attempts at investigation. Recently, The Times of India mentioned that as much as Rs two thousand crore may be generated this year as black money because of these capitation fees in the state of Tamil Nadu alone, with advance booking being taken for postgraduate seats at the time of MBBS admissions (3).However, for obvious reasons, hard evidence is

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certificate by the state health authority, and not left to annual negotiations every year between the government and the managements. Adoption of this system would ensure that: a. internship is restored to its rightful place as a period of development of skills; b. quality would be ensured in admissions; c. the farce of closing ones eyes to capitation fees would be abolished; d. black money transactions would be eliminated; e. managements would have sufficient funds to run their institutions; and f. multiple examinations and the consequent strain on candidates would be avoided. Delayed admissions Although the last date for admissions has been mandated by the Supreme Court, in point of fact there is no way this can be regulated or enforced, particularly in deemed universities. This results in students being admitted several months after the last date with a consequent loss of curricular time. The records are corrected to make it appear as if the candidates have been admitted prior to the last date. In postgraduate courses, occasionally, the admissions are given as late as nine months after the last date. As can be understood, this seriously compromises the available period of time for the course to be completed for the candidate and consequently affects quality. The regulatory agency should ensure that all admissions are reported to it the day after the last date prescribed by the Supreme Court. The database including biometric data should be maintained by the MCI and no admissions should be permitted after this date. Once the admissions are frozen by record in the MCI on the last date, the institutions would not have the option of admitting candidates late and then correcting the records to show that they have been admitted prior to the last date. Skewed distribution of medical colleges The 335+ medical colleges in the country are distributed in a skewed fashion, with nearly 70% falling in the states of Maharashtra, Karnataka, Kerala, Tamil Nadu, Andhra Pradesh and Pondicherry, and only 30% in the rest of the country. This, in spite of the MCIs requirement that to start a new medical college at any site, one would have to obtain a no-objection certificate from the concerned state health authorities which would be issued after making a need appraisal for another medical college at that site. The state authority would have to certify that there is sufficient clinical load in that area to sustain a medical college (4). Perhaps because of easier access to these NOCs in the southern states or the greater profitability potential of starting an institution in these states, medical colleges have got clustered in these states. In the city of Pondicherry with a population of less than 10 lakhs there are eight medical colleges, some within a stones throw of one

another. This process of clustering has an enormous impact both on the availability of faculty in these medical colleges and on the patient load, since there are neither enough trained faculty nor enough patients requiring health care to meet the requirements of all the medical colleges in terms of MCI norms. Until a proper policy is laid down by the Government of India in this regard, and the NOC criteria are strictly enforced, clustering will continue to occur. The problem that clustering of medical colleges causes to the availability of clinical material and faculty is dealt with subsequently. Shortage of faculty One of the major issues where dubious practices are adopted by institutions at the time of MCI inspection is regarding the presence of an adequate number of faculties according to requirements. It is well known that large-scale import of teachers occurs in private institutions on the day before, or on the day of, inspection to be presented to the assessors as existing faculty. Government institutions are not without fault as they deal with this issue by large-scale transfers of teachers from one institute to another just before inspection, only for the teachers to be returned to their parent institution after the inspection is over. The practice has, unfortunately, extended even to super-specialty courses and there are examples, though not common, of the MCI having sanctioned superspecialty courses based entirely on imported faculty with not a single permanent faculty member who works full time in the institute concerned. Allotment of postgraduates to an institute based on the number of professors and associate professors in that institution is an added incentive to the institutions to import more faculty for inspection to increase their quota of postgraduate seats. The impact on education in the long term can well be understood. Shortage of faculty is the direct result of an enormous increase in the number of medical colleges, particularly in the last couple of decades, with the increase in postgraduate seats not keeping pace with this increase. The reluctance of postgraduates to enter the teaching profession has compounded the problem. Measures by the MCI such as physical verification, ignominiously referred to as head counting, at the time of inspection (assessment) and maintenance of a national database of teachers and their institutions have not entirely put an end to the problem. These measures only ensure, to some extent, that no teacher is presented by two or more colleges in the same year. Even this is only a half measure. During the current year itself many teachers are under investigation by the MCI, because their names appear in more than one college faculty (5).The vast majority of teacher imports consists of private practitioners not attached to any medical college who make their services available at an exorbitant fee to present themselves as teachers for a couple of days during inspection. This is not prevented by the MCIs database of teachers. Since their names are not recorded in any other institution, they escape detection. Year after year, the same practitioners are called by the concerned institutions during inspection. The second measure adopted by the MCI to overcome the shortage

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of teachers is to marginally reduce the number of teachers required by some departments (6). This measure compounds the problem since it is an admission that the earlier norms were not fixed after proper application of mind. Further, it ignores the fact that many of these teachers, particularly in the basic sciences, are involved not only in teaching the MBBS course, but also in allied disciplines like nursing and dental courses run by the same private institution. Hence reduction in the number required only adds to the workload of the existing teachers. The problem is not impossible to solve. . An increase in the postgraduate seats, which is the strategy adopted by the MCI, would take several years to make up for the deficiency of teachers, by which time the number of medical colleges would have increased further, since there is no moratorium on new medical colleges. To make up the teacher shortage, there must be an increase in availability of teachers in the short term and in the long term. Several measures can be adopted for this purpose.

syllabus of both courses is essentially the same); and 10.Recognition of all qualifications given by the National Board of Examinations as equal to the corresponding postgraduate degrees. These short term measures have already been recommended to the MCI over a year ago. No specific action has been taken although the shortage of teachers has reached critical dimensions.

Long term measures

Three measures are proposed. First, there must be an alteration of the student teacher ratio from the current fixed norm of 1:1 for an associate professor and 1:2 for a professor, depending on the needs of individual departments and their capacity to train postgraduate students. These current norms may be appropriate for a clinical discipline but a teacher in a preclinical or a para-clinical discipline may be allowed to take more postgraduate students. Second, special incentives should be given to postgraduate students joining the basic disciplines where there is a shortage of teachers, such as a lower fee, immediate appointment to the faculty on qualification or joining the faculty with a higher rank, etc. Third, there must be a critical review and fixing of fresh norms for teachers in various pre and para-clinical and clinical disciplines which are realistic and take into account the current numbers of teachers available. Strict action on the part of the regulator to implement some of these suggestions supported by strong political backing will go a long way towards eliminating the unhealthy practice of importing teachers to fool the assessors.

Short term measures as an immediate solution

These measures are: 1. Relaxing the eligibility criteria for teachers as a temporary measure; 2. Giving special weightage and incentives for teachers in critically short subjects by higher increments, accelerated promotion or starting with a higher designation; 3. Allowing doctors with postgraduate degrees who have worked in medical colleges without teaching designations to be recruited as teachers, subject to fulfilling a minimum number of years in that specialty; 4. Recognising foreign qualifications and degrees which are now under reciprocal de-recognition largely for political reasons; 5. Employing retired teachers on a part time basis; 6. Sharing of faculty in critical departments such as Forensic Medicine between adjacent medical colleges; 7. Allowing adjunct faculty from the clinical side to teach pre- and paraclinical disciplines where there is a critical shortage of faculty as a temporary measure; Some examples of this would be surgeons teaching anatomy, physicians or paediatricians teaching physiology, pharmacologists teaching toxicology and pathologists teaching forensic medicine. 8. Allowing honorary faculty to fill the gaps on a temporary basis (these can be from the pool of private practitioners who have postgraduate qualifications); 9. Removal of all restrictions on teachers with non-medical qualifications in the basic disciplines (these are now subject to several restrictions as regards promotional avenues, number allowed as a percentage of the total faculty strength of the department, and source of non-medical postgraduate qualification whether from a faculty of medicine or a faculty of science- the former being allowed and the latter prohibited from joining a medical college although the

Shortage of clinical material for teaching purposes

A medical college draws its sustenance and its reputation for excellence as a teaching institution from the quality and quantity of clinical material available therein for training undergraduates and postgraduates. It is well known that there is a tremendous shortage of clinical material in many of the medical colleges, since treatment is not free or only nominally free. Clustering of medical colleges has worsened this problem. Hence the number of patients available for teaching is suboptimal. This is sought to be overcome by the unhealthy practice of bringing in truckloads of patients on the day prior to inspection from the neighbouring villages, who are then paid for their services once the assessment is over. Several inspectors have stated to me that many of the so-called patients lying in the wards do not have any specific illness and they may not even have been admitted in the relevant disciplines called for by their symptoms. In one institution, I was told, removal of the sheet covering an apparently sleeping patient in one of the gynaecological wards revealed a male! Together with this practice, figures for daily outpatient attendance are falsified and inpatient records and operation

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and procedure statistics are doctored to show sufficiency as per MCI norms. Since the inspection by the MCI is not really a surprise inspection, there is sufficient time for the institutions to resort to this practice. One way of rectifying this is to make sure that the inspection is really an unannounced surprise inspection without prior notice. Alternatively, a re-inspection may be carried out without notice shortly after the first, to ensure that the figures shown at first inspection are genuine. Also, the MCI inspectors may verify the genuineness of the operation lists and other procedures by crosschecking them with investigation data, pathology records, etc. Unfortunately, MCI inspectors would then have to work not only as assessors but as detectives and spies as well! The provision of a well-equipped skill laboratory can to some extent mitigate the problem although it would not be sufficient to substitute for a lack of clinical material. Skill laboratories can serve for training students and allowing them to practice prior to handling patients, but can in no way simulate real patients. Yet another method of increasing availability of clinical material is to make it mandatory that 50% of beds are earmarked for free patients who would not have to pay for admissions, procedures or investigations. The state can ensure this in return for permitting another medical college. The major reason why patient load is minimal at several of these institutions is the fact that treatment becomes prohibitively costly and beyond the reach of the common person.

resources required to run it. Exemption, of course, would have to be made for equipment for departments such as radiology and pathology which necessarily have to be done in-house. Even here, one would have to seriously consider whether costly services, such as magnetic resonance imaging, should be permitted to be shared with other health care facilities, with students being sent offsite for training purposes. The central government should also consider whether the duty on medical college equipment can be reduced or waived in view of the countrys need to increase the doctor- patient ratio to 1:1,000 which is the goal sought to be achieved. As regards library facilities, permitting electronic libraries instead of hard copies would tremendously reduce the capital expense on purchase of books and journals. Through the Union Ministry of Health, arrangements can be made with the National Medical Library to procure and supply electronic learning resources at subsidised rates for medical colleges and permit them to subscribe to journals through national facilities such as Electronic Resources in Medicine in India . In fact, what the MCI should insist on is not sufficient numbers of hard copies of books and journals but a greater availability of computer hardware and terminals to permit e-learning. Investment on this will certainly be cheaper in the long term for the institutions.

Neglect of research
An earlier publication from one of the authors had pointed out the woeful dearth of research activities in medical colleges (7). This is in spite of the fact that a research laboratory has been made a mandatory requirement for all departments in medical colleges (8). However, the equipment for these research laboratories has not been clearly specified. The MCI is aware of the lack of research in medical colleges and has recently revised the guidelines for criteria for the promotion of teachers to include publication of research papers (9). However, enforcement has been postponed for some years and the old system has been allowed to continue for unknown reasons. With rapid advancement in medical knowledge, research training has to become compulsory for all medical graduates, if not faculty. One method of ensuring this is done is to ensure that the guidelines for promotion mandating a minimum number of research papers are strictly enforced and strengthened. Medical postgraduates with PhD degrees should be encouraged to join medical colleges to give a fillip to research activities. For enabling this, one may have to consider incentives such as allowing them to join in a higher post compared to those without research degrees, or giving weightage to the period spent in acquiring a PhD degree for promotion purposes. Also, a minimum number of indexed publications from the college should be insisted upon at the time of mandatory renewal of permission which now takes place, or is supposed to, once in five years. Postgraduate dissertations need to be taken up with a lot more seriousness than is done at present.

Shortage of equipment and learning resource facilities

To those in the medical education profession it is well known that much of the life-saving equipment is brought on hire for the MCI inspection. In fact, this has now almost become a cottage industry with several agents contacting medical colleges to supply equipment and books as per the MCI list for a few days during the inspection process. A major reason for this lacuna is the prohibitive cost of equipment, medical books and journals. In fact, the annual subscription for journals alone in a medical college may run as high as Rs 50 lakh or more. Much of the equipment is not indigenously manufactured and is very expensive. Customs duty exemption is not available for all the items on the MCI list. The institutes hesitate to procure the items since substantial investment is required and the returns are not guaranteed in the short term. Solutions are not hard to come by. The first priority is to revisit the list of required instruments in the MCI list, which has not been revised for years. A drastic revision is called for, removing all obsolete equipment which is particularly prominent in the list required for the basic science departments. As regards equipment required for clinical facilities, MCI should seriously consider whether outsourcing of some investigations which are not required to be done in-house for training purposes, should be allowed. This list will include many types of equipment required for biochemical investigations. Implementation of this suggestion would go a long way in reducing expenses on purchase and maintenance of this equipment and the human

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Unhealthy practices in evaluation

The most odious, and perhaps the most dangerous, of the unhealthy practices in medical education is the interference in the evaluation system. Ever since internal assessment became compulsory and was included in the summative evaluation process, manipulation of internal assessment marks has become the norm in many institutions. It is not uncommon to see that almost all candidates get more than 90% in internal assessment so that they may get a push in the final examinations, should they fall on the borderline between passing and failing. The Central University of Pondicherry, at one time, tried to investigate the genuineness of internal assessment in the affiliated colleges after seeing the high scores obtained by almost all candidates. In spite of the liberal internal assessment marks, there was a hue and cry from the candidates about possible bias in internal assessment, since they did not trust the system to be fair due to lack of transparency. As usual, the MCI acted tangentially. Instead of correcting the deficiencies in the system, it responded by reducing the weightage for internal assessment in the summative process (10). In a skillbased profession such as medicine, where comprehensive assessment is not possible in the summative process due to paucity of time, one would have expected the weightage given to internal assessment to be increased rather than decreased. The interference in the assessment process has now permeated to the final examinations although only in a limited number of institutes. Due to the large number of medical colleges becoming deemed universities, the same administration has control both of the teaching-learning process and evaluation, with no external monitoring. This makes manipulation of the final results easier. However, manipulation of the final results is not seen exclusively in private universities. Recently, there was an investigation into the addition of as many as 45 marks in the final year examination to the marks of individual candidates to enable them to pass in the Tamil Nadu Dr MGR Medical University, , whereas the MCI permits only a maximum of five marks. This happened in a premier medical university in the country. Closing ones eyes to this process would result in the release of a large number of sub-standard graduates into the healthcare system. There are no easy solutions to this problem. Proper internal assessment is a question of the attitude of the faculty to this important modality of evaluation in the medical field and development of a trust in the system by the candidates. The institution of more objective and transparent methods of evaluation can, to some extent, reduce this problem. Surprise inspections by the regulatory agency to see the internal assessment record may also mitigate this evil. Quality control in the summative process is easier and one can seriously think of having either total external evaluation or three external examiners, instead of two, as at present. Examiners may be appointed centrally, from a national list of approved examiners. Likewise, attendance rules must be made stricter and exemption from minimum mandatory attendance should be the exception rather than the rule.

Conclusion
In conclusion, it may be stated that there are a number of ills and unethical practices which plague the medical education system in the country at present. There is a total system failure and blame cannot be apportioned to the managements of the colleges alone. The Union Government and the political class have not exhibited awareness of the issue, nor responded with vigourous corrective measures; and the erstwhile MCI, before it was superseded, had reacted with half measures without thinking through the issue, implementing solutions which sometimes compounded the problem. The regulatory agency in the past has also not shown the will power or the ability to enforce the rules, such as they are. The profession is apparently apathetic to the state of affairs and the public is totally ignorant of the downhill slide in the quality of doctors. A greater awareness in the medical community of the danger of ignoring these issues and their impact on the health of the nation would go a long way towards correcting some of these deficiencies. The new board of governors of the MCI has an unenviable task ahead of it as did its predecessor board. However, there are solutions to many of these issues. These need to be enforced straightaway if medical education is not to fall in to a bottomless pit.
references Medical Council of India. List of Colleges teaching MBBS [Internet]. NewDelhi: MCI;2010[cited 2011 Nov 1]. Available from: http:// www.mciindia.org/InformationDesk/MedicalCollegeHospitals/ ListofCollegesTeachingMBBS.aspx 2. Ananthakrishnan N. Medical education in India: is it still possible to reverse the downhill trend? Natl Med J India. 2010;33:100-4. 3. Narayan P, Ramya M. BE, MBBS courses are long term investment plans [Internet]. 2011 Jun 24 [cited 2011 Nov 1]. Available from: http:// timesofindia.indiatimes.com/home/education/BE-MBBS-courses-arelong-term-investment-plans/articleshow/8971071.cms 4. Medical Council of India. Procedure to start a new college [Internet]. NewDelhi: MCI;2010 [cited 2011 Nov 1]. Available from: http://www.mciindia.org/InformationDesk/ForColleges/ ProceduretostartaNewCollege.aspx 5. Medical Council of India. Urgent notice [Internet]. NewDelhi: MCI;2011 Jun 13 [cited 2011 Nov 1]. Available from: http://www.mciindia.org/ tools/announcement/URGENT_NOTICE_Faculty.pdf 6. Medical Council of India. Minimum standard requirements for the medical college, for 100 admissions annually, regulations 1999 [Internet]. New Delhi:MCI;1999 Apr 29 [cited 2011 Nov 1]. Available from: http:// www.mciindia.org/for-colleges/Minimum%20Standard%20Requireme nts%20for%20100%20Admissions.pdf 7. Ananthakrishnan N. Acute shortage of teachers in medical colleges: existing problems and possible solutions. Natl Med J India. 2007;20:259. 8. Medical Council of India. Requirements to be fulfilled by the Applicant Colleges for obtaining Letter of Intent and Letter of Permission for Establishment of the new Medical Colleges and Yearly Renewals under Section 10-A of the Indian Medical Council Act, 1956 [Internet]. NewDelhi:MCI;2009 Oct 13[cited 2011 Nov1]. Available from: http:// www.mciindia.org/for-colleges/LOI,LOP,Renewal.pdf 9. Medical Council of India. Minimum qualifications for teachers in medical institutions regulations, 1998 [Internet]. NewDelhi:MCI;1998 [cited 2011 Nov 1]. Available from: http://www.mciindia.org/RulesandRegulations/ TeachersEligibilityQualifications1998.aspx 10. Medical Council of India. Salient feature of regulations on graduate medical education 1997 [Internet]. NewDelhi:MCI;1997 [cited 2011 Nov 1]. Available from: http://www.mciindia.org/RulesandRegulations/ GraduateMedicalEducationRegulations1997.aspx 1.

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Indian Journal of Medical Ethics Vol IX No 1 January - March 2012

Disability certificates in India: a challenge to health privacy

NN MISHrA1, LS PArKEr2, VL NIMGAONKAr3, SN DESHPANDE1
1

Department of Psychiatry, PGIMEr-Dr rML Hospital, New Delhi 110 001 INDIA e-mail: indusszgenes@gmail.com 2 Center for Bioethics and Health Law, University of Pittsburgh, Pittsburgh, PA 15213 USA e-mail: lisap@pitt.edu 3 WPIC, University of Pittsburgh Medical Center, Pittsburgh, PA 15213 USA e-mail:VishwajitNL@upmc. edu Corresponding author NN Mishra e-mail: drmishrarml@yahoo.com

Abstract A disability certificate is necessary to access benefits afforded under the Persons with Disabilities Act (1995) in India. This paper analyses this requirement and concludes that it constitutes a major challenge to maintaining privacy of health information especially for persons with mental health disabilities in India and recommends modifications in the certificates format and use, to reduce the magnitude of privacy infringement for those using the disability certificate to access benefits to which they are legally entitled.

concessions and tax rebates are also available for the disabled and their escorts or caregivers.

Impact of disability certificates on privacy and welfare

Despite the advantages it affords, the Act also presents a challenge for the disabled in another area of their health and rightsnamely, the protection of their privacy. These privacy concerns arise because of the way the Act is implemented and what individuals must do in order to qualify for benefits under its provisions. Specifically, individuals seeking benefits must obtain a disability certificate from a specified government healthcare provider. The certificate itself needs to display a photograph (certified by due authority), as well as the name and address of the individual, which can increase the risk of confidentiality breach should the certificate be misplaced or stolen, or merely viewed by unauthorised persons. Further, the certificate details not only the diagnosis, but also the duration of illness and degree of disability. The effective utilisation of the various provisions of this Act plays an integral part in ultimate socio-economic benefits that disabled individuals may obtain (4), and yet many who would qualify for these benefits are prevented by their disability from obtaining the disability certificate without assistance. Therefore, it is necessary that family members or caretakers of the affected individuals help them obtain a disability certificate. This need for assistance requires that the disabled person share information that she or he might prefer to keep private. While some disabilities are readily apparent and cannot be kept from others, some disabilities could be kept largely private. Obsessive compulsive disorder, depression, and many other mental illnesses, for example, are not as readily apparent as impairments of sight or mobility. Nevertheless, those with such disorders may need assistance in obtaining a disability certificate, perhaps because their disorder prevents them from being sufficiently motivated to apply for benefits on their own. Other mental illnesses may be cognitively impairing so that a person cannot, at least at some times, complete the tasks of applying for a certificate. Symptoms of paranoia might prevent a mentally ill person from approaching a doctor for certification and then subsequently approaching a government office for specific benefits. So, even to apply for a disability certificate, some disabled individuals will have to suffer the invasion of privacy of their health information by sharing the information with a family member or other interested party. Of course, this is not the only context in which individuals with health conditions must disclose private information in order to

Background on disability in India

Disability can be painful and burdensome for individuals and may present special challenges for their families. When employing social and political tools to address these burdens, it may best be conceived according to a social model (1), whereby disability results from the relationship or fit between an individuals abilities and the social as well as physical environment in which she lives (2). Every society must attempt to address the disabilities of its members in a way that respects the autonomy and human rights of disabled people and allows them to pursue a satisfying quality of life. Yet, each country must address the disabilities of its residents according to its strengths or capacity. Indeed, conditions that are disabling in one society may not be so, or not to the same degree, in another because of cultural and local differences (e.g., physical disabilities in a rural context may not be so restrictive in an urban setting with ample resources). Moreover, different societies have different levels of resources available to help individuals compensate for or accommodate disability. In India, the 2001 census identified 21.9 million people with disabilities, though the number has been estimated to be as high as 70 million (3, 4). One social provision intended to alleviate the burden of disability for these individuals is the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act of 1995 [PWD Act] (5). According to the Act, disability includes blindness, low vision, cured leprosy, hearing impairment, locomotor disability, mental retardation, and mental illness. The PWD Act constitutes an important step towards enabling the disabled in India. Based on the provisions of the Act those who are 40 per cent disabled, as certified by a governmental medical authority, are entitled to receive particular benefits from the government of India (GoI). A certain percentage of government jobs, for example, is reserved for those with certified disabilities. Educational institutions that receive aid from the GoI must reserve at least three per cent of their seats for persons with disabilities. Travel

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seek help. Patients do this when they seek healthcare at a clinic or from a physician. Healthcare professionals are then ethically and legally obligated to keep such information confidential both to respect patients privacy and autonomy and to protect them from possible harms that could result from the disclosure of private health information. In order for healthcare delivery to be effective, patients must feel comfortable disclosing private information to professionals without fear of social or economic repercussions, embarrassment, or stigma (6). Similarly, people with illnesses and disabilities are often dependent on family or nonprofessional caregivers for assistance and care. They must share private informatione.g., about their condition, bodily functions, and needswith these nonprofessionals in order to receive help, sometimes including help with activities of daily living. While family members and nonprofessional caregivers do not have legal duties to respect the privacy of their charges, and certainly do not have a professional code of ethics that mandates respect for privacy, they do have ethical obligations to respect the privacy of those they love or provide care for (7). So, the unavoidable need to disclose a disability to a family member in order to receive help in applying for a disability certificate may not be that different from asking family members for aid in going to the doctor, taking medicine, or accomplishing daily tasks. Ideally, family members then assume the ethical obligation to respect their relatives privacy and keep her health information confidential. Moreover, family members may have an interest in safeguarding information about non-obvious disabilities that are present in their family, because of concerns about stigma and discrimination that attach to such conditions, especially as the familial and genetic aspects of some conditions become better understood. Regarding the disability certificate, however, what is a distinctive and largely avoidable invasion of privacy is the subsequent use of the certificate, once it is obtained. Currently, the disability certificate must be presented in government and private offices to receive a variety of concession certificates or tax benefits. The concession certificate, in turn, must be presented to a variety of non-health professionals in order to obtain benefits. The ticket clerk at any Indian railway station, for example, must be presented the concession certificate in order to obtain a discounted ticket or monthly pass. Each of these documentse.g., the travel concession certificate and ticket itselfunnecessarily documents the nature of the disability and links the persons name and disability on a form that may go astray and that is certainly viewed by people who are not bound by any regulation or code of ethics to keep the persons health information confidential. For individuals with less obvious disabilitiese.g., mental illness or retardation, or cured leprosy that leaves no obvious disfigurementit is seeking the benefits to which the PWD Act entitles them that exposes them to the greatest risks of stigma and discrimination. Because mental illness and mental retardation (and leprosy) are highly stigmatising (8), individuals with these conditions may justifiably have some hesitation in using the certificate to seek

benefits to which they are entitled. Further, the certification of the mentally ill person may not only stigmatise the patient, but also his family members. The labeling of the person can affect marriage prospects of family members (especially female siblings and offspring), as well as business opportunities and access to private health or life insurance for family members. Moreover, other agenciese.g., the railway ministryissue certificates affording concessions for a wider range of disabilities than those covered by the PWD Act. A person with cancer, for example, may receive a discounted railway fare. Yet the price to be paid for this otherwise valuable and well-intentioned benefit is exposure of her cancer condition, something that could otherwise be kept largely private beyond her immediate family and healthcare settings. In some cases, even the train ticket itself will state the cancer diagnosis. While cancer may now be less stigmatising than mental illness or leprosy, some people still retain erroneous beliefs that cancer is contagious or that having cancer is a reflection of a persons character. Thus revelation of ones cancer diagnosis to a ticket checker or fellow passenger can be stigmatising and lead to social shunning as well as more official forms of discrimination.

recommendations to increase privacy protection while maintaining safeguards against fraud

The unnecessarily cumbersome and humiliating process of declaring the nature of ones disability in multiple documents at multiple offices should be streamlined to protect individuals privacy as much as possible. Furthermore, it is unnecessary to state the nature of the individuals disability on each of these documents. The process for obtaining and using a disability certificate to avail of legally provided benefits should be revised. Both the union and state governments issue guidelines regarding issue of disability certificates. At present, certification of a persons disability for purposes of receiving benefits under the PWD Act, 1995, is only obtainable from designated physicians at government facilities. While only doctors with seniority and experience, and only government hospitals with requisite facilities at the district level and above, can issue certificates, concerns may be raised about the possibility of physicians issuing erroneous or even fraudulent disability certificates to persons without a qualifying disability. At present, very little is taught about disability and disability certification at the post graduate level in India. Training regarding the disability certification process should be a mandatory component of a doctors curriculum, and hospitals should offer continuing education to maintain an up-to-date understanding of the process and regulations among doctors. Such training would serve to reduce error. Intentional fraud may be more difficult to address. Disability certificates are issued only by designated doctors using a prescribed form, and a doctor who signs these certificates must include his Medical Council registration number. This measure is designed to ensure accountability

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and minimise the potential for fraudulent certificates to be issued. Two additional measures could enhance these preventive measures. First, it could be required that all disability certificates be crosschecked by a second doctor of the same institution so that a single individual cannot wrongly issue disability certificates without being detected. Disputes between those physicians would be resolved by a designated hospital administrator. Ideally, this would be the same hospital administrator who countersigns the certificate. Doctors who are repeatedly found to be issuing certificates in error (inadvertently or intentionally) could be required to complete training on the certification of disability and penalised, if necessary. If their inappropriate issuing of certificates continued, they could be penalised by the hospital administration, as their error or fraud places the institution itself at risk of accusations of fraud. Moreover, when certification of disability is undertaken, patients and their family members should be informed, and required to acknowledge that they are legally responsible for any misrepresentation or misinformation they offer regarding the disability. Second, the directorate general of health services, the agency responsible for implementation of the disability certificate provision of the Disability Act, 1995, could institute a process of auditing institutions for the appropriateness of their issuing of disability certificates. Records of the issue of certificates should be retained by the hospital and made available for periodic audit, which would involve review of the medical record, including laboratory test results, history and physical notes, or results of assessment questionnaires developed to assess the duration and type of symptoms and degree of impairment, in the case of mental disability. Details of such an audit process would need to be developed by the office of the directorate general. It may be thought that the greatest threat of fraud occurs not at the level of doctors certifying disability and issuing a disability certificate, but subsequently when perhaps fraudulent (fake) documents are presented in government or private offices to receive a concession certificate or tax benefit, or later, when the concession certificate is presented for the particular benefit, such as a discounted train ticket. Linking the certificate, the bearers photo, and a description of the disability may be considered necessary in order to prevent fraud at this level. In effect, those issuing concessions or checking train tickets are turned into agents of fraud prevention by asking them to verify that the person in front of them is truly disabled. But railway employees, for example, are not qualified to assess whether the person before them truly has cancer or mental illness; therefore, requiring production of a statement describing the nature of the disability at these levels is not warranted. At most, they should be required to verify identity by matching names on documents or matching a photo on a document to the person presenting herself.

A revised, more appropriate processrespectful of privacy and mindful of risk of fraudwould proceed in the following manner. Upon presentation of the initial medical certification of disability, and verification of her identity, the individual should be issued a document stating the concessions or benefits for which she is qualified without any further detail about the nature of her condition. Such a document regarding concessions might bear the individuals photograph if identification of the document holder is necessary to prevent fraud (and no other form of photo identification is available and reliable). However, following certification of disability, the nature of the disability need not be publicly linked with the document, photo, or individual. Further, there is no need for a travel ticket, for example, to state the nature of the individuals condition. There should be no requirement that the individual carry with her a copy of her initial certification of disability or that she supply it upon demand to government workers and ticket checkers throughout her daily life. This is an unnecessary ordeal that presents multiple daily breaches of privacy for those whose disabilities could otherwise be kept more private. Preservation of such privacy is an individuals right as a matter of respect for her autonomy. It is also critically important in order to avoid stigma, discrimination, and other negative social, economic, and psychological consequences (6). Acknowledgment: We would like to acknowledge the support of the Fogarty International Center NIH Training Program for Psychiatric Genetics in India, Grant #5D43 TW006167-02. We are grateful to Dr R P Beniwal and Dr T. Bhatia for their suggestions on preventing fraud and formulating guidance about false disability certificates.
references 1. 2. Morris J. Impairment and disability: constructing an ethics of care that promotes human rights. Hypatia. 2001;16(4):116. United Nations. United Nations Convention on the Rights of Persons with Disabilities (UNCRPD)[Internet]. UN; 2006 Dec 13[cited 2011 Mar 13]. Available from: http://www.un.org/disabilities/convention/ conventionfull.shtml Sridhar L. 70 million disabled in India, and only 2% are educated and 1% employed. Infochange features [Internet]. 2003 Jun [cited 2011 Mar 13]; Available from: infochangeindia.org/.../70-million-disabled-in-Indiaand-only-2-are-educated-and-1-employed.html Vijaykumar S, Singh U. PWD Act: awareness among beneficiaries and members of rehabilitation team. IJPMR. 2004 Apr;15:12-16. Ministry of Welfare, Government of India. The Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995 (PWD Act, 1995): Ministry of Welfare, in the Gazette of India, Extraordinary, Part II Section 3. Mishra NN, Parker LS, Nimgaonker VL, Deshpande SN. Privacy and Right to Information Act, 2005. Indian J Med Ethics, 2008;5(4):158-161. Buchanan A. Testing and telling?: implications for genetic privacy, family disclosure and the law. J Health Care Law. 1998;1(2):391-420. Corrigan PW, Penn DL. Lessons from social psychology on discrediting psychiatric Stigma. Am Psychol. 1999 Sep;54(9):765-76.

3.

4. 5.

6. 7. 8.

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Ethical aspects of public health legislation: The Mental Health Care Bill, 2011
HArISH THIPPESWAMY 1, KAUSIK GOSWAMI 2, SANTOSH CHATUrVEDI 3
1 Assistant Professor,2 Senior resident, 3 Professor, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore 560 029 INDIA Corresponding author: Harish Thippeswamy e-mail: docharisht@gmail.com

Abstract A legal framework is essential to promote and safeguard the interests of persons with mental illness. Since the Indian Lunacy Act, 1912, mental health legislation has come a long way. Currently efforts are underway to modify the existing Mental Health Act taking into account the resolutions under the UN Convention on the Rights of Persons with Disabilities. The proposed Mental Health Care Bill, 2011 incorporates promising modifications, like caregiver nominated representative consent support for decision , , , making, and advance directive for persons with mental illness in its rubric, which seems potentially beneficial to the patients. The proposed new bill should facilitate and strengthen a mental health policy which provides acceptable, accessible, and equitable mental health care. A law becomes meaningful when it is realistic, implementable and ethical in provisions. In this comment, we take a critical look at the proposed The Mental Health Care Bill, 2011 through the lens of ethical principles.

Background
Historically, legislation has played an important role in protecting and promoting the rights and interests of persons with mental illness. Mental healthcare in India was brought under the purview of legislation for the first time in the year 1858, through the Indian Lunacy Act. This facilitated the setting up of mental asylums to admit and segregate those who by reason of insanity were perceived to be troublesome and dangerous. The Act was amended in 1912 putting civil surgeons in charge of the mental hospitals instead of the Inspector General of Prisons, as in the Act of 1858. The amended Act of 1912 laid out the rules and procedures for admission to and discharges from hospitals and asylums and guided mental health care in India for the next 75 years (1). In the year 1987, the Indian Parliament passed the Mental Health Act (MHA) which came into force in the year 1991. The MHA focused largely on administrative aspects and institutional care. Since the time of its implementation, the MHA, 1987, has been criticised for focusing heavily on administrative aspects, and institutional care, and for ignoring community psychiatric care (2). The Act has also been criticised for failure to comply with the guidelines of the National Mental Health Programme and the World Health Organisation on discharge care and rehabilitation, and for being unsuccessful in addressing the problem of social stigma (3, 4). On March 30, 2007, India joined the community of 82 countries which are signatories to the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD) which is the first comprehensive human rights treaty of the 21st century

and marks a significant change in attitudes and approaches to persons with disabilities (5). India, as a signatory to the UNCRPD, is obligated to bring its existing laws into congruence with the basic principle of the UNCRPD which views persons with disabilities as subjects with rights, not objects of charity. Hence, the Government of India (GOI) initiated the process of developing the National Health Bill, revision of the existing Mental Health Act of 1987, and amending the Persons with Disabilities Act. The task of amending the existing MHA 1987 was assigned by the Ministry of Health and Family Welfare (MOHFW), GOI (6) to the Indian Law Society, Pune. The draft of The Mental Health Care Bill, 2011, referred to as the draft Bill in this article, has undergone several modifications through consultative processes. It is felt that the new legislation should facilitate and strengthen a mental health policy which provides acceptable, accessible and equitable mental health care (7). The importance of ethical issues in public health policy is being increasingly recognised worldwide. A law becomes meaningful when it is realistic, implementable and ethical in its provisions. The US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research published the Belmont Report in 1979 (8). This report is an articulation of the key ethical principles for research and clinical care involving human subjects. The key ethical principles according to the Belmont Report are respect for persons, beneficence and non-malfeasance, and justice. Respect for persons involves honouring the autonomy of an individual to deliberate upon and act according to his/her goals and protecting the autonomy of each individual. Beneficence involves acting to do good for participants or to act for their well-being while also taking steps to avoid and minimise harm (i.e., non-malfeasance). These concepts of beneficence and non-malfeasance are commonly understood as expressed in the Hippocratic Oath and, thus, extend from the typical doctorpatient relationship to the context of clinical research. Justice involves fairness in the distribution, care, and service to equals in equal manner. Hence, it is of paramount importance to look critically at the draft bill from an ethical perspective, with reference to respect and confidentiality, along with the core principles of autonomy, beneficence, non-malfeasance and justice (9). In this commentary, we examine the provisions of the draft Bill available on the website of Ministry of Health and Family Welfare, Government of India (6)

Analysis
The draft Bill incorporates several new important provisions under its fold. It lays emphasis on human respect. The

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prejudicial term mentally ill gets replaced with person with mental illness in order to separate the person from the illness. This avoids branding an individual and helps in reducing the stigma. New provisions like nominated representative, consent supported admission and advance directives have , , been introduced for persons with mental illness.

Confidentiality The draft emphasises the confidentiality of patient-related information in both the virtual and real spaces. Confidentiality in research settings and during the proceedings of the mental health review commission is emphasised in the draft Bill. Standard of care

Nominated representative
Any person who is 18 years of age, and above, and is competent can appoint a person who is above 18 years age as a nominated representative (NR) The representative helps the . patient to interact with the mental health system and also acts as a legal guardian for the patient. However, there is a possibility of conflict with the autonomy of the patient if the nominated representative does not act according to the patients wishes. Hence, it is of great importance that the competence of the patient to appoint a representative needs to be assessed with care and concern by a mental health professional trained in assessing competence. It would be better if a structured instrument is used to assess competence in order to bring in objectivity. Inadequate assessment of competence leads to erroneous decisions and hence compromises the autonomy of the person thereafter.

The Central Mental Health Authority has prescribed minimum standards for facilities, personnel training, and services. This should help to bring equal treatment into care and also ensure that every patient receives a basic minimum standard of care, thus fulfilling the principle of justice. Legal capacity According to the draft Bill, all patients with mental illness have legal capacity and may/ may not require support to exercise their legal capacity. The level of safeguards provided is based on the level of support needed, with a rider that the support should be treated as a temporary phenomenon. There is provision for a review at the end of a prescribed period to check for the ability to make independent decisions and for further need of a high level of support. These provisions emphasise the autonomy of patients. Supported admissions This measure was earlier known as admission under special circumstances under which a patient could be admitted for up to 90 days under a single admission process. Under the draft Bill, this period has been reduced to 30 days, and may be extended up to 90 days. Further admission beyond this period of 90 days can be extended up to 180 days subject to certain conditions. This has been done to ensure the safety of the person. Treatment shall only be provided after taking into account any existing advance directive or with the support of the nominated representative. This covers the important ethical principle of non-malfeasance. Prohibited treatment The draft Bill makes a provision for prohibition of certain treatments. The policy seems to have been derived from the principle of non-malfeasance. There is a prohibition on electroconvulsive therapy (ECT) without the use of muscle relaxants and anaesthesia (unmodified ECT). However, the practical implications of this prohibition need consideration. In routine clinical practice, there are often situations like life-threatening catatonia wherein a patient may need urgent electroconvulsive therapy. Moreover, modified ECT is expensive and requires the specialised services of an anaesthetist. Given the manpower and financial constraints in our country, a complete ban on unmodified ECT may result in failure to provide this effective and life-saving treatment to all those who need it. This goes against the ethical principle of beneficence. Serious adverse effects are a rarity with unmodified ECT, and we feel that it should be allowed under rare circumstances.

Consent
The draft Bill gives great importance to free and fully informed consent. The autonomy of the individual takes precedence over the best interest principle, with the exception of certain clinical situations. Unilateral decision making by the clinician citing the best interest principle has been discouraged. In situations where there is lack of full capacity to give consent, the new draft allows a nominated representative, whose bona fides and credentials are clear to the service provider, to be part of the supported decision making. This gives greater autonomy to the patient. The draft Bill makes it mandatory for the health service provider to proactively empower the patient to either accept or refuse treatment. However, during emergency medical interventions, the principle of beneficence, i.e. doing good, takes precedence over autonomy. In such situations, the consent may be presumed unless there is a previous declaration to the contrary. The draft Bill requires a personal assessment of each individual case whenever there is a hint of lack of full capacity to give consent. The thorough assessment of evolving capacity and intellectual maturity and documentation involves the investment of a significant amount of time by the clinician. Though this is in keeping with the ethical tenet of autonomy, we feel that this might amount to additional workload, involving a considerable amount of time for the clinician. Moreover, clinicians need to be trained to assess the above; in the absence of adequate training and standardised instruments, the objective may not be achieved. Given the inadequacy of infrastructure and resources in our country, this needs to be examined from a pragmatic angle.

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The draft disallows the administration of ECTs in any form to minors. Severe mental disorders such as schizophrenia and bipolar illness often set in during adolescence and can present as catatonia which can be life threatening. It is well known, and a scientifically established fact, that catatonia responds very well to treatment with ECT. A blanket ban on ECT in minors can be potentially dangerous to the life of the patient. Hence, provision should be made to allow administration of ECTs in minors only during exceptional clinical circumstances. The draft Bill puts significant restrictions on psychosurgery by making it mandatory to acquire approval from the State Mental Health Authority (SMHA). Psychosurgery is rare and is still an unexplored area. It is a complicated decision which should be taken by a well informed clinical team comprising of experienced neurosurgeons, anaesthetists and psychiatrists. We are not sure whether the panel of SMHA has enough expertise to decide on such complicated clinical issues. Elaborate procedures are likely to discourage a clinician from offering a potentially beneficial clinical procedure to a patient. We agree that safeguards need to be in place to avoid the exploitation of patients. To ensure the same, we feel that the decision should be at the discretion of the local institutional ethics committee. Moreover, the field of neurosurgery has advanced with the application of newer techniques with greater accuracy and fewer complications. We feel that the process of making it mandatory to obtain permission from the SMHA could impair the progress of research in psychosurgery and also may cause delay in the treatment for certain patients. Discharge planning In another welcome change, the new draft makes provision for discharge planning to ensure continuity of care with a proper referral and briefing of the caregiver/family member of the patient. Advance directives One new feature of the draft Bill, which needs to be evaluated in greater detail, is the inclusion of the provision of advance directives Advance statements documenting mental health . service consumers preferences for treatment during a future mental health crisis or period of incapacity have gained salience in recent years in the United States and some European countries, including the United Kingdom. The new draft Bill makes a definite effort to incorporate this practice. The new provision of advance directives is in keeping with the principle of autonomy. Every person, irrespective of their mental health status has a right to make a written statement known as an advance directive. The advance directive is a legal document which provides the individual with the autonomy to decide the manner in which he/she wishes to be cared for during a future period of illness. A patient can appoint a person in the order of precedence as nominated representative during his period of illness. In the present draft, the advance directive needs to be certified by a medical practitioner regarding the competence of the

individual. However, this might give rise to a dilemma for the clinician as certification of advance directive may potentially lead to legal entanglement. As previously discussed, the caveat of allowing any medical practitioner who may not have formal training to assess competency apply here also. The treating practitioner is bound to honour the advance directive as expressing the wishes of the patient. The draft allows the provision of amending, cancelling or revoking the advance directive to the individual at any point of time. This substantially strengthens the principle of autonomy. However, keeping to the principle of beneficence, a blanket refusal of all kinds of treatment in the advance directive is considered invalid unless approved by the district panel of the Mental Health Review Commission (MHRC). Advance directives give a greater degree of autonomy to the patient; but they could come into conflict with the best interest principle. The treating doctor may hesitate to treat the patient in a crisis situation where the choice of treatment is contrary to the directive, unless an appeal is made before the MHRC for overruling of the same. Though advance directives have been implemented in many countries and happen to be a salient feature of the draft Bill, this measure is often differently defined and interpreted in different countries. The distinguishing features are the extent to which they are legally binding, whether health care providers are involved in their preparation and whether an independent facilitator assists in their preparation. The differing nature of advance statements is related to the diverse models of care upon which they are based and the legislative and service contexts in which they have been developed (10). In this regard, it would be appropriate to evaluate this new provision with respect to existing advance directives in other countries like the USA and UK. In the United States, the Patient Self-Determination Act of 1990 followed legislation for medical advance directives and cleared the way for psychiatric advance directives. Unlike in India, the federal nature of the US constitution translates into variations in formulation and implementation of laws among the different states. However all U.S. states permit competent adults to use generic health care decision laws to make at least some psychiatric treatment choices in advance, typically through the use of a durable power of attorney (11). Additionally, 25 states have, since the early 1990s, enacted specific psychiatric advance directive statutes (12). While the specific features of psychiatric advance directive laws vary considerably by state, there are some commonalities. Under the Patient Self-Determination Act, any hospital receiving federal funds must notify admitted patients of their right to make an advance directive, inquire whether patients have advance directives, adopt written policies to implement advance directives under state law, and notify patients of what those policies are. No such compulsion for notification is present in the current draft in India. Another feature which is present in US advance directives, but absent in the Indian draft, is the provision of detailed checklist forms including different

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options of admission and treatment to help consumers prepare advance directives. These might be useful inclusions in the Indian draft as they uphold the principle of informed decision making and thus autonomy. The principle of beneficence is highlighted in both countries by making it possible to override an advance directive if it is deemed to be against the best interest of the consumer (13). In the United Kingdom, Scotland has pursued a different policy from that prevailing in England and Wales. In Scotland, parliament has included advance statements in recent mental health legislation, that is, the Mental Health (Care and Treatment) (Scotland) Act, 2003. The written statement may be invoked or revoked only in the presence of a witness who must certify the capacity and intent of the consumer. The Indian draft has improved upon this clause by requiring a medical practitioner to certify the competence of the individual. Under the Scotland Act, if treatment is given that conflicts with the advance statement, the responsible clinician under the Act must provide the reasons in writing to the person concerned, ie the person named under the Act, the guardian, the welfare attorney, and the Mental Welfare Commission; as well as file a copy in the persons medical records. This is slightly different from the Indian draft, wherein prior application has to be made to the district Mental Health Review Commission. In England and Wales, on the other hand, advance statements have been recognised under common law for some years, and their place has now been defined by statute in the Mental Capacity Act, 2005. However, in the case of mental disorders, mental health legislation (currently the Mental Health Act 1983) takes precedence over any provisions in the Mental Capacity Act. Advance statements can thus be overridden. Concern over public protection has outweighed concerns about patient autonomy. Advance statements have therefore taken an essentially clinical form, independent of their statutory basis (10). In Germany, Austria and Switzerland, advance directives are legally binding upon the clinician, and can be overridden only by means of a court order (10). To conclude, in comparison with other countries, the provision of advance directives in India seems well formulated and justifies the principle of autonomy, even as it gives due importance to the principle of beneficence.

admissions. These changes help enhance the degree of autonomy for patients which was not adequately addressed in the original act. The draft mentions the practice of nondiscrimination while treating patients with mental illness, which, in turn, reflects the principle of justice. In the case of research involving patients with mental illness, the draft mandates the obtaining of free and informed consent, and the upholding of the ethical principles mentioned above. The draft Bill details the confidentiality issues of patients. It has tried to protect the rights of users and family members taking ethical principles into account. The section on prohibited treatments and psychosurgery needs to be re-examined. Overall, the proposed amendments highlight the role of ethical issues in formulating a public health policy to protect the rights and interests of users, especially those of the vulnerable groups. Rules framed over such an ethical matrix are more likely to be acceptable to the community.
references 1. 2. Ganju V. The mental health system in India: history, current system, and prospects. Int J Law Psychiatry. 2000 May-Aug;23 (3-4): 393-402. Seshadri H, Seshadri H. Needed: new Mental Health Act [Internet]. The Hindu. 2005 Jan 30 [cited 2011 Nov 22].Available from: http://hindu. com/2005/01/30/stories/2005013000951100.htm Rastogi P. Mental Health Act, 1987 - an analysis. JIAFM [Internet]. 2005 [cited 2001 Nov 22];27(3):176-9. Available from: http://medind.nic.in/jal/ t05/i3/jalt05i3p176.pdf Trivedi JK. Mental Health Act, salient features, objectives, critique and future directions. Indian J Psychiatry [Internet]. 2009 [cited 2011 Nov 22]. 51: 11-19. Available from: http://www.indianjpsychiatry.org/cpg/ cpg2009/article7.pdf United Nations. Convention on the Rights of Persons with Disabilities [Internet]. 2007[cited 2011 Nov 22]. Available from: http://www.un.org/ esa/socdev/enable/conventioninfo.htm Ministry of Health and Family Welfare, Government of India. The Mental Health Care Bill 2011 [cited 2011 Nov 22]. Available from: http://mohfw. nic.in/WriteReadData/l892s/6420662643DRAFT%20 THE%20MENTAL% 20HEALTH%20CARE%20BILL.pdf Murthy P. The Mental Health Act 1987: Quo Vadimus? Indian J Med Ethics. 2010 Jul-Sep;7(3): 152-5. National Institute of Health. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research [Internet]. Washington, DC: US Government Printing Office; 1979 Apr 18 [cited 2011 Nov 22]. Available from: http://ohsr. od.nih.gov/guidelines/belmont.html Lawrence DJ. The Four Principles of Biomedical Ethics: A Foundation for Current Bioethical Debate. J Chiropr Humanit. 2007;14:34-40. Henderson C, Swanson JW, Szmukler G, Thornicroft G, Zinkler M. A typology of advance statements in mental health care. Psychiatr Serv. 2008 Jan;59(1): 6371. Fleischner R: Advance directives for mental health care: an analysis of state statutes. Psychol Public Policy Law.1998 Sep; 4(3):788804. Swanson J, Swartz M, Ferron J, Elbogen E, Van Dorn R. Psychiatric advance directives among public mental health consumers in five US cities: prevalence, demand, and correlates. J Am Acad Psychiatry Law. 2006;34(1):4357. Swanson J, McCrary SV, Swartz MS, Van Dorn RA, Elbogen EB. Overriding psychiatric advance directives: factors associated with psychiatrists decisions to preempt patients advance refusal of hospitalization and medication. Law Hum Behav.2007 Feb;31(1):7790.

3.

4.

5.

6.

7. 8.

9. 10.

Conclusion
The proposed The Mental Health Care Bill, 2011 makes several provisions which are beneficial to patients. It upholds supported decision making over the best interests principle and offers the option to make an advance directive on treatment issues. This is in accordance with the principle of respect for persons and helps protect the autonomy of the individual. The draft also makes a provision for supported

11. 12.

13.

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Case stUdY

Observational study of cervical cancer

FrOM: CASEBOOk ON ETHICAL ISSuES IN INTERNATIONAL HEALTH RESEARCH

Although this case study is based on research that took place in the 1970s, the questions that it raises remain relevant today. Cervical cancer causes at least 273 000 deaths globally every year, and about 85% of these deaths occur in developing countries. The incidence of invasive cervical cancer has decreased in countries where women have access to regular Papanicolaou (Pap) smears(1) and subsequent treatment of pre-malignant cervical dysplasias(2) readily available. Most often, women with fatal cases of cervical cancer have never had a Pap smear or have to wait long intervals between Pap screenings. Cervical dysplasia ranges from low grade squamous intraepithelial lesion (SIL) to high grade SIL.(3) The next stage is carcinoma in situ, indicating that although cancerous cells are present they have not yet spread. In the 1970s, there was lack of consensus in the medical community about which types of dysplasia would progress and become cancerous. Many countries with adequate health facilities took an aggressive position and treated early dysplasia. In many developing countries, however, decisions about when to treat were guided by the belief that not all dysplasias progress to cancer, and this position was supported by previous studies of the natural history of cervical cancer. Thus, in developing countries the most widely accepted stage at which to begin treatment was that of carcinoma in situ, indicating that the cells had become cancerous but remained limited to the cervix. If doctors could more accurately predict which dysplasias would progress to carcinoma in situ, they could be more specific in deciding which cases to treat early. The development of a more precise diagnostic method that could detect whether a dysplasia was of the type that progresses to cancer would save money and ensure that more women would receive treatment. To design guidelines for a national control programme for cervical cancer, the national medical research council of a South Asian country funded an observational study of cervical cancer to determine which dysplasias were most likely to progress to cancer. The study, approved by the research ethics committee of the research council, took place over 12 years, beginning in the mid-1970s. Eight government hospitals in one of the countrys

major cities participated. Most of these hospitals provided both general and specialized gynaecological care but were busy and did not have adequate facilities to manage patients with cancer. Patients with cancer were, therefore, referred to the nearest regional cancer centre for treatment and follow up, with a standard 6-month waiting period to begin treatment. The researchers elicited the help of community health workers to inform women about the study and encourage them to go to the city hospitals for Pap smears. Women who presented at the eight government hospitals were informed about the study, and were asked to give a Pap smear with informed consent. Since most women in the study were illiterate, the researchers provided information in simple, non-medical language and obtained verbal consent. The researchers did not inform the women that their lesions might progress to cancer. Women were not made aware that treatment was available. By the ninth year, researchers had identified more than 1000 women with varying degrees of cervical dysplasia. Women found to have a positive Pap smear at intake were followed up every 3 months, to record the progression of their disorder on the basis of the Pap smear. The end-point for treatment was defined as the development of carcinoma in situ, at which time they were referred to the nearest regional cancer centre, which had a very long waiting list. By the time some of these women were seen by an oncologist, the lesion had progressed to a higher level. Midway through the study, a leading North American medical journal published the results of a longitudinal study of cervical cancer. The study concluded that cervical dysplasia was a precursor for cervical cancer, and thus that all forms of dysplasia warranted treatment. Despite these new findings, the researchers continued with the study. By the end of the study, 71 women had developed malignancies. In nine of these women, the disease had already spread to other parts of their body. The research team provided no treatment to the women once the study had ended.

Questions
1 Discuss the ethical issues raised by this observational study. 2 Given the shortage of staff, facilities, and equipment in the government-run hospitals, was the medical research council justified in conducting this study? Could national guidelines have been set up without conducting this study?

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3 Should continuing services have been offered to participants after completion of the study? If so, what services should have been offered? 4 Does diagnosing a condition or disease during research result in a duty (obligation) to provide care and follow-up for that condition? Is this duty the same whether the condition is diagnosed to include patients in the study or to exclude them? 5 Do the researchers have any responsibility to take stock of the situation at least mid-way through such longitudinal studies? Should the sponsors ask for such an evaluation? 6 Should this study have had some stopping rules, or a monitor? 7 Should this study be accepted for publication? If not, how should the results of this study be made generally known to others?

changes of the uterine cervix, together with viral, bacterial, and fungal infections of the cervix and vagina. Cervical screening is a relatively simple, low-cost, and non-invasive method. Regular screening for cervical cancer reduces both the mortality from and incidence of cervical carcinoma. (2) Abnormal development or growth of tissues, organs, or cells. It is the earliest form of precancerous lesion. Dysplasia can be diagnosed as either high or low grade, with high grade dysplasia indicative of a more advanced progression towards malignant transformation. (3) A general term for the abnormal growth of squamous cells on the surface of the cervix. The changes in the cells are described as low grade (LSIL) or high grade (HSIL), depending on how much of the cervix is affected and how abnormal the cells are. HSIL is regarded as a significant precancerous lesion, whereas low-grade SIL (LSIL) is more benign, since most of these lesions regress.
Reprinted from: Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva: World Health Organisation 2009: 124-5.

Notes:
(1) A routine screening test used for the detection of early cervical abnormalities, namely precancerous dysplastic

Case stUdY resPonses

Knowledge vs ethics in clinical research in resource-poor settings: a clinicians perspective

B SUBHA SrI
rural Womens Social Education Centre, 61, Karumarapakkam, District Kancheepuram, Tamil Nadu 603 109 INDIA e- mail: subhasrib@gmail.com

This case study of the 1970s (1) no doubt raises several ethical questions. I will however try to look at the case study from the perspective of a gynaecologist and primary care physician attempting to establish a community-based cervical cancer screening and care programme in rural Tamil Nadu. There is enough knowledge today that cervical cancer is caused by the Human Papilloma Virus and progresses through stages of cervical intraepithelial neoplasia (CIN), carcinoma in situ (CIS) to invasive cervical cancer. This knowledge determines the modalities of screening and treatment recommended today for cervical cancer and its precursors. However, while attempting to analyse the case study to draw lessons for current practice, one needs to start from the scientific evidence that was available regarding cervical cancer precursors at the time of the study, to consider whether a study to understand the natural history of cervical cancer was necessary, and whether the study was justified in its design of following up women with proven dysplasia without any intervention, given the evidence available at that time.

Since I have no personal knowledge of the clinical scenario in the period of the study, I looked through literature on the history of cervical cancer treatment and also spoke to two senior gynaecologists who were working in premier medical institutions in India at that time. I understand that the progressive nature of cervical dysplasias (as they were called then) to cervical carcinoma was well known by the early 1970s. In 1968, Richart (2) indicated that all dysplasias have the potential for progression. However, there seems to have been a lack of clarity on how exactly each grade of dysplasia behaved and what proportion actually progressed to invasive cancer. This was an important issue, especially while evolving guidelines for treatment in high disease-prevalent resourcepoor settings like India. Based on existing understanding, while carcinoma in situ was most often treated with hysterectomy, severe forms of dysplasia were often treated with an excisional cone biopsy of the cervix. Treatment for mild and moderate dysplasia did not seem to have any standard protocol and varied between individual facilities. Answers to questions

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regarding the natural history of dysplasia would therefore, at that point, definitely have helped in evolving context-specific guidelines for clinical decision making. Also, there seems to have been a widely held view that since cervical cancer was highly prevalent in the developing countries of south Asia, and there was a possibility of ethnic variations in disease pathology, studies on South Asian women were needed. While these arguments may be used to justify planning a study to understand the natural history of dysplasia and cervical cancer, how does one decide if such studies are really needed? How does one decide when the evidence generated in developed countries is relevant to the question at hand, and when indigenous studies are in fact needed? Moving on, even if one were to accept that the study was indeed justified, was the methodology planned appropriate and ethical? First, did the institutions carrying out the study have the necessary infrastructure to take on a study of this magnitude? The study involved following up women with possible cancer precursors with the potential of developing into a serious, life-threatening disease. Were the institutions capable of the stringent recall and follow-up required in such cases? Given that they could not handle the final disease if it developed, were they even justified in taking on the study? Given the significant false negative rates of Pap smears, well known in the 1970s, were they justified in relying on Pap smears alone to reach an end point of CIS to begin treatment when it was likely that this already meant foci of invasive carcinoma were present in the woman? This was a time when modalities like colposcopy were being used in other countries (3,4). Other technologies were thus known and available to evaluate women with cervical dysplasia, while this study relied solely on Pap smears. Was it okay to agree on CIS as the end point for follow-up when it seems to have been common knowledge then that severe dysplasia or CIN III and CIS were part of the same continuum? Should there not have been systems for interim monitoring of such a long-term study so that changes in global clinical practice, such as those influenced by the other study published in the North American journal, would have been taken into account? If the questions that the study had set out to achieve were already answered by another study, should this study not have been terminated? Shouldnt women in this study have been given the benefit of knowledge gained from that study and offered treatment? There are also some other questions that I would pose as a clinician. How does one balance the roles of a clinical caregiver and researcher, especially when these may be in conflict? In this study, the researchers were mostly clinicians whose primary responsibility was patient care. Shouldnt the basic principles of clinical ethics of beneficence, non maleficence and patient autonomy apply in these settings too? Arent these also ethical principles guiding research? If one accepts this, then, in view of the long-term nature of the follow-up and the implications of not intervening, the women should have been consulted at every stage in decision-making regarding their care, regardless of their initial consent to be part of the study. In this particular

case, the initial consent also seems to have glossed over several important facts well known to the researchers at that time, such as the lesions potential to progress to invasive cancer. Patient autonomy cannot be overridden even if the clinician believes in good faith that what s/he is doing is best for the patient though even this does not seem to have been the case here. Also, the least the clinicians could have done was to expedite treatment for these women once they developed carcinoma. That they failed to do so reveals a total lack of concern for the women in the study as compared to the research outcomes. Then, what about public health ethics? How does one strike a balance between clinician and public health researcher? What if, truly, this study had uncovered a different pattern of progression of dysplasias in south Asian women? Would it then have been justified in its design and methodology? Would the larger good of understanding cervical dysplasia in south Asian women to benefit women in the future have been justification enough for following up women with dysplasia in this study without intervention? I do not think so. Even if the study were justified in terms of the larger public good, adequate safeguards should have been built in, so that women in this study also received the benefits of existing and emerging knowledge, whether from this study or elsewhere. Interim monitoring of results, terminating the study in the face of the results of the other study, expediting treatment for women whose dysplasias progressed in severity - all of these should have been necessarily built into the study. This case study brings up several concerns on the regulation of research studies in developing countries including India. While the situation now is vastly changed from the era of this study, it is also true that there is an explosion of clinical trials happening now in India. Questions such as what kinds of trials may be carried out in developing countries like India, and what kinds of problems they should address, gain relevance. Even if one were to accept that certain problems relevant to our country need clinical research based here, how does one safeguard the interests of trial participants? This gains significance especially given the large scale poverty, marginalisation, and lack of literacy and information in countries like ours. How does one ensure that the marginalised are not exploited and are in a position to negotiate safeguards for their benefit in a research setting? Research priorities in developing countries need to be driven by the sometimes unique clinical needs of these countries. However, carrying out research studies in resource-poor settings can be challenging. This can very often result in compromises in ethical standards for reasons of practicality . The role of regulation and regulatory bodies is, therefore, crucial in such settings. This is all the more critical given that, most often, research subjects in these settings are the very marginalised. Acknowledgement: I wish to acknowledge the contributions of Dr Asha Oumachigi, Retired Professor of Obstetrics and Gynaecology, JIPMER Pondicherry; Dr Lakshmi Seshadri, Retired Professor of Obstetrics and Gynaecology, CMC, Vellore, and Dr

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Rakhal Gaitonde, Public Health Researcher, Chennai, during the development of this comment.
references 1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva: World Health Organisation 2009;124-5. Richart RM. Natural history of cervical intraepithelial neoplasia. Clin

3.

4.

Obstet Gynecol. 1968:10:748-84. Coppleson M. The value of colposcopy in the detection of preclinical carcinoma of the cervix (Three years experience at King George V Memorial Hospital, Sydney). BJOG: An International J Obstet Gynaecol Br Emp. 1960 Feb; 67:1123. doi:10.1111/j.1471-0528.1960.tb06945. Navratil E. Colposcopy. In: Gray L A, editor. Dysplasia, carcinoma in situ and microinvasive carcinoma of the cervix uteri. Springfield, IL: CC Thomas; 1964. p. 228-83.

Lost opportunities
PrIYA SATALKAr
Independent researcher,12A Fruitstraat, 974 1AN, Groningen THE NETHErLANDS e-mail: drprivasatalkar@gmail.com

Do we need different ethical standards for observational research as compared to experimental study designs like randomised controlled trials (RCT)? Should we allow different standards of care if the research is funded and carried out by local research councils in developing countries without external sponsors? How could we carry out clinical research in resource-constrained, publicly-funded healthcare facilities without compromising the quality of care given to research participants? These questions are discussed against the backdrop of an observational research study undertaken by the national medical research council in a south Asian country in the 1970s to determine which lesions of cervical dysplasia gradually progress to malignant changes (1).

Observational research versus experimental research designs

This particular observational study, to understand the progression of cervical dysplasia to malignancy, was expected to guide a national cervical cancer control programme in resource-constrained settings in a south Asian country in the 1970s. In the absence of conclusive scientific evidence that could adequately predict the progression of cervical lesions to cancer, such research was justified, rather commended, for it promised the rational use of available resources to detect and treat cancers in a timely fashion. Nonetheless, we can discuss a number of ethical issues in this study, ranging from informed consent and the standard of care to researchers responsibility towards research participants at the end of a study and the role of external study monitors. It must be noted that most of these issues have been debated extensively in the context of experimental study designs, particularly RCTs, and standards established (2). Can we apply the same standards to an observational study? I argue that irrespective of the nature of the study design, one must aim for the highest ethical standards for any research that involves human subjects and I elaborate my reasons below. When an individual agrees to participate in research, s/he should have been informed about the risks involved, and there should be evidence that s/he has understood them. Depending on the subject of study, and the study design, the risks could

vary in severity, as can the potential harms and benefits. One can argue that in case of an RCT, participants are at risk of receiving a less effective drug, or experiencing the previously unknown adverse effects of a new drug. It is often argued that observational studies by their very nature pose less risk and harm to participants as compared to experimental studies. In the study under discussion, however, more than 1,000 women were diagnosed with cervical dysplasia or premalignant lesion of cervical cancer. Though these women were entitled to standard treatment and care for their cervical lesions diagnosed during this observational research, they received only a referral to a regional cancer hospital with a long waiting period to begin their treatment. Thus they did not get any benefits out of their study participation except the early diagnosis of cervical lesions and in fact had to face the emotional and physical suffering associated with diagnosis of cancer. This is particularly important because these women were not informed that their lesions could be cancerous before obtaining their informed consent. This was similar to the other infamous Tuskegee study which is acknowledged to be unethical observational , research. Research is carried out to advance scientific knowledge in the hope that it will benefit humankind. There are numerous reasons and motivations for individuals to participate in research (3). One reason is altruism -- to contribute to the production of knowledge. Are we willing to distinguish between knowledge produced through experimental studies and that through observational research? If not, why should individuals who may have enrolled due to the desire to benefit humankind -- be treated differently and protected by different ethical standards and guidelines based on the type of study in which they have participated? There are common elements in the design and implementation of various research studies, particularly around the involvement of human subjects. Few researchers have made attempts to improve reporting of observational research to give it the same scientific rigour as in experimental studies. The initiative Strengthening The Reporting of Observational Studies in Epidemiology (STROBE) has developed a checklist of 22

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items to improve the quality and reporting of observational studies (4). Eighteen out of these 22 points are common to experimental study designs such as case control, cohort and cross-sectional studies. Though STROBE is intended to improve the quality of reporting in observational studies, it paves the way for a similar exercise with ethical guidelines across various study designs. Below, I discuss some aspects of the cervical cancer study, drawing upon ethical standards and guidelines recommended for experimental studies.

medical information is provided in culturally and linguistically appropriate terms. This requires collaborative efforts between researchers and community members. In this case, before enrolling in the study, the women should have been informed that their cervical lesions could progress to cancer and of the various treatment options available. They should also have been informed that they could choose not to be part of the study, and there would be no adverse consequences of their refusal. These steps in obtaining informed consent protect women from coercion to participate in research and respect their free choice (9).

Informed consent
Any research enterprise is a collaborative activity involving various stakeholders such as researchers, health professionals, study participants, communities or institutes where the study takes place, and sponsors. Each stakeholder has different interests, and different motivations to be part of the study. This can lead to conflicts of interest and even adversely affect the partnership (5). The researchers in this case were healthcare providers (doctors, nurses and other staff including laboratory personnel) in eight public hospitals providing general and specialised gynaecological care. Being staff of the public health system, they were guided and bound by the instructions and protocols issued by the ministry of health and national medical research council. The study participants were women in the reproductive age group, most of whom were illiterate and belonged to the urban communities around these hospitals. We do not have any other socio-demographic information about these women, but it is possible that they had limited access to the healthcare system. They may have believed that enrolment in the research study would give them access to, and medical attention from, qualified doctors in public health facilities. Thus, we are analysing the interactions between researchers and study participants in the macrocosm of the health system (6), including the larger socio-political context. While obtaining informed consent from the participating women, the researchers would have used simple, nonmedical language to explain the nature of the study and the role of study participants. This is important given the fact that most women were illiterate and even otherwise, general literacy may not always facilitate medical literacy. But the researchers did not inform the participants that their lesions could be of cancer, nor did they inform them of the available treatment and care options. This can be interpreted as intentional withholding of information essential for the women to make an informed decision regarding their participation in the study. In most south Asian countries, there is a clear hierarchical power relationship between healthcare providers and patients/ healthy volunteers (as it is in this study) (7). It is often believed that the doctor knows what is best for the patient, and this trust can compel persons to participate in research if the doctor advises it, particularly if the same physician is involved in regular care as well as research activities (8). To ensure that research participants consent only after being adequately informed, it is essential that comprehensive

Standard of care
The other contentious issue in this situation concerns the standard of care that the researchers and sponsors are expected to provide to study participants during and at the end of the study. This gets further complicated when an external sponsor conducts a clinical trial in a developing country, where people have limited access to any form of therapy let alone the global standard of care (10). In case of an RCT, it is expected that the benefits of a study will be made available to participants and the entire community; in case resources are limited, they will be made available for a reasonable time according to CIOMS, Guideline 10 (2). The case study we are discussing here is an observational study and not a clinical trial but the issue of the standard of care is still important. The absence of an external sponsor does not change the obligation of local researchers towards study participants (11). The debate on the global single standard of care and the need for double standards is ongoing; there are no universally accepted solutions (10,12, 13). How do we define the standard of care through the public healthcare system in a south Asian country? Let us examine what could be considered the standard of care in this particular case study. We do not know the exact details of this countrys health expenditure and budget, but the fact that the study was commissioned by the national medical research council in order to design a cost effective cancer control programme suggests that resources were limited. As per national guidelines, this country did not aggressively treat lesions of cervical dysplasia, though this was a common practice in other, resource-rich, western countries. The city in which the study took place had at least eight large publicly-funded hospitals providing general and specialised gynaecological care. However, these hospitals were overburdened and did not have adequate facilities for managing cancer cases. The city also had a regional cancer facility but it had an average waiting period of six months before a patient could see an oncologist and begin treatment. It seems that the local standard of care for women with cervical dysplasia in this particular country was referral to the regional cancer institute following diagnosis, and a six month wait before they could start treatment. Thus, whether or not a woman was a study participant, there was no proactive management of cervical dysplasia in this health system, and the regional cancer hospital was clearly overworked and unable to manage patients in a timely fashion. Further, this study was

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designed, funded, approved and conducted by the various agencies and institutes within the national ministry of health. No external agency was involved in this study. The researchers could argue that they provided the participants with the best available local treatment options. In fact, the women benefited from their participation in the study as screening ensured early diagnosis of cervical carcinoma in situ, and those with this diagnosis got immediate referral to the regional cancer hospital. If they were not part of the study, they would have reached the regional cancer hospital at a later stage of their cervical cancers, possibly when the cancer had spread to other parts of the body. This referral also marked the end of the researchers responsibility towards the study participants. Once referred to the regional cancer institute, the women were left on their own to negotiate access to further treatment and care. Here we have two groups of women with different healthcare needs, those in various stages of cervical dysplasia, and those with cervical carcinoma in situ who were referred to the regional cancer hospital. Midway through the study, evidence became available that all stages of cervical dysplasia are essentially premalignant and warranted treatment to prevent progression to cancer. By this time, the investigators had identified more than 1,000 women with varying degrees of cervical dysplasia. These women should have been treated according to the new therapeutic gold standard: aggressive treatment of cervical dysplasia in order to prevent cervical cancer. Is it possible for a south Asian country with limited resources to provide treatment which is more feasible in the developed world? Even if we talk only about 1,000 women from the study with lesions of cervical dysplasia who should have been aggressively treated as per the new evidence; neither the recruiting hospitals nor the regional cancer hospital was capable of responding to the treatment needs of 1,000 women in a timely fashion. The national medical research council should have anticipated this situation, given the fact that it was carrying out a large, long-term observational study, and was expected to provide study participants with treatment, not just early diagnosis. The medical research council could have negotiated better functioning referral links between recruiting hospitals and the regional cancer facility to create fast-track access to cancer management for the study participants. A functional referral link would also have meant that the researchers continued to follow women referred to the regional cancer facility. It can be argued that the national medical research council should have ensured that all the recruiting hospitals were capable of managing lesions of cervical dysplasia as per the available standards, that is to treat these lesions aggressively. This gained even more importance when the evidence became available to support this strategy.

of their study. Half-way through this observational study, a North American journal published clear evidence that cervical dysplasia is premalignant and should be treated aggressively to prevent cancers. This was a point at which the researchers should have reassessed the objective of their study. If the new evidence was convincing, it should have been used to ask the medical research council to discontinue the study. Moreover, continuing the study in spite of available evidence against it meant causing more harm to the study participants. This is where an external monitor of the study plays an important role (14). Having no direct stake or involvement in the research, an external monitor is in a neutral position to recommend discontinuation of the study in the light of conclusive evidence generated from the same study or through other publications. Stopping the study at the right time is essential but not enough. The researchers also needed to develop a system to manage about 1,000 patients needing aggressive treatment as per available evidence. This could have been achieved through collaboration between the recruiting hospitals and the regional cancer facility. A triage of study participants distributing patients between the recruiting hospital and the regional cancer institute based on urgency, other risk factors, and underlying complications could have been a step towards effective and timely management of the large number of patients who needed to be treated as an entitlement of their study participation.

Conducting ethical clinical research in resourceconstrained public hospitals

Most publicly funded hospitals in developing countries have limited financial, material and technical resources, and the eight public hospitals which were recruiting women in this cervical cancer study were no exception. There are three questions that need to be considered while involving such resourceconstrained public hospitals in clinical research. First, what are the ethical challenges faced while conducting research in such settings? Second, what are the consequences faced by the hospitals due to their participation in research in terms of care provision to the research participants. Finally, is there a potential to strengthen health systems through participation in research? All eight hospitals recruiting women for this study were in urban settings and provided general and specialised gynaecological care. They were clearly overworked and understaffed, and did not provide cancer care and treatment. Recruiting patients through public hospitals ensured that women who were likely to benefit through the study participation got represented in the study. Women were required to visit the centre every three months for a Pap smear. Since this was a gynaecological hospital, Pap smears were routinely conducted, and one could be confident that the hospital staff was trained to properly collect and accurately interpret the smears without harming the patients. However, it seems that the researchers underestimated the hospitals ability to meet their obligation to provide aggressive treatment to large numbers of women with cervical dysplasia

role of the external study monitor and terminating the study

Researchers are also responsible for keeping themselves updated on evidence that becomes available during the course

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if research found this to be the best way to manage such cases. There does not seem to have been adequate discussion of how the hospitals were going to manage study participants apart from providing referrals to the regional cancer institute. One benefit of conducting research through the public health system is its strengthening as a consequence of research participation (). However, one must ensure that hospitals are equipped to provide standard care and treatment to research participants before starting such research activities. In fact, this study created an opportunity for the eight public hospitals to build their capacity in the management of early cases of cervical dysplasia. This was particularly important when it became evident that all lesions of cervical dysplasia need to be aggressively treated. By the ninth year of the study, they had about 1,000 women with various stages of cervical dysplasia who should have been aggressively treated. The regional cancer institute alone would not have been able to handle this sudden increase in patient load without assistance from the recruiting hospitals. Women with locally spread cancers and other complications could have been given priority treatment at the regional cancer institute whereas other uncomplicated and early cervical lesions could have been successfully managed at the recruiting hospitals with support and mentoring from cancer specialists. These skill-building activities should have taken place before starting the study. Once the staff of these hospitals had enough experience in managing the research participants with cervical dysplasia, these services could have been provided to other women through these hospitals. This would have achieved institutional capacity building, with eight hospitals becoming able to diagnose early cases of cervical dysplasia and manage them appropriately with monitoring and technical support from the regional cancer hospital. The aim of the national medical research council was to develop a national cancer control programme through this research. If it had built the infrastructure and expertise of these eight hospitals during and after the research, the medical research council could have actually paved the way for future implementation of a national cancer control programme. In summary, we can conclude that the public hospitals should be involved in research provided they are equipped with the resources and skills to implement ethical and scientific research, and to provide standard care and treatment for research participants. Research activities can build the institutional capacity, infrastructure, expertise and staff skills to provide better health services in the future, thus strengthening health systems.

be drawn up even before recruiting participants. Researchers are obliged to make their best efforts to provide the highest attainable care to research participants, irrespective of whether the study sponsor is external or local. It is advisable to assess the study periodically and check if the study objectives are still relevant. An external and neutral study monitor could play a crucial role in monitoring the studys implementation and recommend continuation or discontinuation of the research based on the available evidence. Observational research can draw upon the same ethical principles and standards that have been developed for experimental studies, though specific details may be needed to incorporate specific challenges posed by the observational nature of the study. As in the STROBE checklist, a structured analysis could be carried out to guide the ethical conduct of observational studies, drawing upon existing guidelines for experimental research like the CIOMS guidelines or the Declaration of Helsinki. Resourceconstrained publicly funded hospitals should be involved in research activities provided they are equipped with the necessary resources and skills to implement scientifically and ethically sound research. Research participation could, in fact, strengthen the public health system by improving the quality of its services. Involving communities in designing, planning and implementing research can empower these communities and protect participants against exploitation.
references Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva: World Health Organisation 2009;124-5. 2. Council for International Organisations of Medical Sciences; World Health Organisation. International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization; 2002. 3. Fry C, Dwyer R. For love or money? An exploratory study of why injecting drug users participate in research. Addiction. 2001Sep; 96(9):1319-25. 4. Vandenbroucke JP, von Elm E, Altman DG, Gtzsche PC, Murlow CD. STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med. 2007 Oct 16; 4(10): e297. 5. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva: World Health Organisation 2009;118. 6. McLaren L, Hawe P. Ecological perspectives in health research. J Epidemiol Community Health. 2005 Jan; 59(1): 6-14. 7. Kottow M. The battering of informed consent. J Med Ethics. 2004 Dec; 30(6): 565-9. 8. Benatar SR. Reflections and recommendations on research ethics in developing countries. Soc Sci Med. 2002 Apr; 54 (7):1131-41. 9. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004 Mar 1; 189(5): 930-7. Epub 2004 Feb 17. 10. London AJ. The ambiguity and the exigency: clarifying standard of care arguments in international research. J Med Philos. 2000 Aug; 25(4): 37997. 11. Bandewar SV, John TA. SEARCHS HBNC trial: towards a broader debate on the ethics of social intervention research. Indian J Medical Ethics. 2011 Apr-Jun; 8(2): 78-85. 12. Benatar SR, Singer PA. Responsibilities in international research: a new look revisited. J Med Ethics. 2010 Apr; 36(4):194-7. 1.
13. Macklin R. After Helsinki: Unresolved issues in international research. Kennedy Inst Ethics J. 2001 Mar; 11(1):17-36. 14. Silverman H. Ethical issues during the conduct of clinical trials. Proc Am

What can we learn from this observational study conducted in the 1970s?
Researchers and recruiting hospitals should be equipped to provide care and treatment to the study participants, and not just stop at the diagnosis of disease as an endpoint of the research. Systematic plans to provide care to participants during and after the study, within reasonable limits, need to

Thorac Soc. 2007 May; 4 (2):180-4. discussion 184.

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Observational research where it is most needed

SUJIT D rATHOD
Division of Epidemiology, 101 Haviland Hall, University of California, Berkeley, CA 94720 USA e-mail: sujit.rathod@yahoo.com

Study rationale and justice

The rationale for this study was the identification of prognostic factors among women with cervical dysplasia. It was conducted in a south Asian country in the 1970s. Given the unknowns with regard to cervical dysplasia and development of carcinoma at the time, and the lack of consensus about which types of dysplasia would progress and become cancerous (1) it was appropriate to observe the natural history of dysplasia. At that time, there was a similar ongoing study, also indicating that clinical equipoise was evident; its results were yet to be published. This study involved another combination of funders, researchers and research ethics boards. Aside from equipoise, additional ethical criteria must be considered, namely: justice, beneficence and respect for persons.

this approach is questionable(3). It is possible, then, to consider the conduct of this cervical cancer research study through both the guidelines in place at that time, and those that have been developed since.

Standard of care and beneficence

The most ethically contentious aspect of this study was the absence of treatment provision by the researchers for women found to have cervical carcinoma. To require that treatment be readily available for conditions that are diagnosed as part of non-therapeutic health research creates a standard that effectively precludes much observational research in the settings where it is most needed. Additional complications would immediately arise: Must the researchers increase the treatment capacity at the regional cancer centre? Or must they start offering cancer treatment at the local hospitals? Would participants be put ahead of nonparticipants on the waiting list, and/or have their treatment paid for? In fact, it is not the responsibility of the public health researchers to rectify the shortcomings of the public health system; that is the appropriate jurisdiction of elected officials and civil society. It is, however, the researchers responsibility to describe the distribution, determinants and consequences of ill health, and to identify potential means of intervention. Thus, the limited treatment capacity in the study area is not ethically problematic. Frequently, it is the case that health research is conducted in areas of limited resources, where the de facto standard of care is below the standards in high-income settings. Though it may appear that the investigators were exploiting the participants lack of access to treatment -- an ethically unsound strategy made infamous by the Tuskegee study of untreated syphilis -- they were not exacerbating the situation for purposes that would not benefit participants. It must be re-emphasised that the researchers were attempting to address a critical gap in the knowledge base around the development of cervical cancer. The knowledge gained could enable more efficient allocation of cervical treatment in these areas of limited resources. Some may question whether this study satisfied the ethical requirement for beneficence, as many women referred for treatment of carcinoma experienced deteriorating prognoses during their lengthy wait before the initiation of treatment. By virtue of the study design, the delays that participating women experienced between the development of carcinoma, the diagnosis of carcinoma, and their entry on the cancer centre waiting list would certainly have been far shorter than for women who were not participating in this study. In spite of

Justice
The importance of this sort of basic scientific investigation cannot be overstated. In the absence of evidence from randomised control trials, guidelines around cancer screening rely on data generated from observational studies. By determining the incidence and prevalence of women with carcinoma in situ, and identifying the features of dysplasia associated with progression to carcinoma in situ, this research could support health policy makers efforts to increase capacity and to precisely target the treatment of cervical cancer. The primary beneficiaries of the findings of this kind of research would be those populations most affected by cervical cancer who happen to be women in developing countries. The burden of research participation should be borne by a sample drawn from populations expected to benefit from the results of the research findings. Thus it is just and appropriate that women in developing countries were enrolled in this study. At the time of this study, the regulatory framework for medical research ethics was still developing. The Nuremberg Code (1949) and the World Medical Associations Declaration of Helsinki (1964 and 1975) were both in existence , while the publication of the Belmont Report (1979) was imminent. The latter document - with its ethical criteria of justice, beneficence, and respect for persons - has particular relevance to this case study, as it was created in response to an observational research study. Yet, all three cover circumstances applicable to either or both intervention and observational research. Of the current major research ethics regimes, only the Council for International Organisations of Medical Sciences has created a separate guideline specifically for epidemiologic research -most recently revised in 2008 (2) -- although the necessity for

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the long wait at the regional cancer center, the post-diagnosis prognosis was undoubtedly enhanced for the 71 participating women diagnosed with malignancies in the study -- a clear benefit of participation.

Informed consent and respect for persons

It is not clear what information was provided to the women as part of their recruitment and enrolment process. That women were not aware that treatment was available on the face of , it, appears incriminating. But in the light of the local standard of care, it is irrelevant that women in other countries would be immediately treated upon detection of cervical dysplasia. The relevant standard is the established, local one: women with carcinoma in situ are candidates for treatment, and these participating women found to have carcinoma were in fact referred to the regional cancer centre. In the 1970s, as now, the Declaration of Helsinki makes clear a medical researchers primary interest is the well-being of the individual participant(4, 5); this ethical standard is satisfied by researchers providing immediate referral to the cancer centre upon detection of carcinoma, as a non-research clinician in this setting would have done. One aspect of this case study requiring additional detail is what women were told with regard to the research question. Informed consent, by definition, must be informative; women need the necessary information to make the decision of whether or not to participate in the research study. These women would have to be told that: a) they were being asked to be participants in a research study; b) the research question concerned identification of cervical features that might predict development of cervical cancer; and c) participants found to have developed cervical cancer would be referred to the regional cancer centre. Some women might have decided that they prefer not to have their cervical health tracked, or that if diagnosed, they would not or could not avail themselves of the treatment offered at the cancer centre. Respecting individual autonomy entails provision of the kind of information necessary for a recruited individual to make an informed decision about participation. Insufficient information is available here to assess whether this ethical imperative was satisfied.

Although investigators and sponsors are generally careful to conduct high-quality research, it is infrequently the case that the result of a single study is sufficient to conclusively answer a research question: replication is at the heart of science. Not only for observational research, but even with randomised controlled trials, consideration of results from several studies is necessary to resolve clinical equipoise. Statistically significant results from early studies of a research question are frequently incorrect(6), and even when correct, the strength of the early findings is often attenuated as the studies are replicated (7). Therefore, in medical research, the conclusions from a systematic review or a meta-analysis, drawing from multiple high-quality studies, are considered the most compelling. Stopping rules feature most prominently in randomised controlled trials, when there is typically a single exposure that is being assessed for a primary outcome. Studies can be halted if an external assessment group judges that at least one pre-specified criterion has been reached. This could be so if interim analysis produced a statistically significant result which is unlikely to be overturned with additional data collection. Another criterion might be that low enrollment or retention figures indicate a high likelihood that the study will not fulfill its objectives. A third is that there is evidence of adverse events associated with participation (8). A recent example in HIV prevention (9) demonstrates that even when one intervention study is halted early, other similar studies may continue, so that the effect of the intervention can be demonstrated consistently and conclusively. In observational research, where multiple exposures and outcomes are typically being assessed, and the exposures are not being allocated by the investigator, these considerations are frequently moot. In conclusion, it is crucial that health researchers continue to focus on the health needs of medically underserved populations. Here, the investigators were conducting observational research in response to a local reality shared by nearly all women in developing countries at that time: that there was an unknown prognosis for women with cervical dysplasia. By virtue of the marginalised status of such populations, they are also typically at greater risk of exploitation. In this case study, the research was conducted primarily with regard to the needs of the local population, and, most importantly, benefited those women who consented to participate. Researchers and their respective research ethics committees are obliged to consider clinical equipoise before and during the trial, though observational research studies are unlikely to involve early stopping rules. When multiple studies have considered a similar research question, those responsible for crafting health care guidelines can draw from the strengthened knowledge base; changing policy requires a resolution of clinical equipoise, and multiple studies are generally required to provide that resolution.
references 1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva:World Health Organisation:2009. 124-5. Council for International Organisations of Medical Sciences. International

Equipoise and stopping rules

Clinical equipoise is again a concern after the publication of a longitudinal study which had been investigating a similar research question as in the south Asian country. Now, the research gap concerning cervical dysplasia and development of cervical cancer is occupied by a single observational study. In this situation, investigators of contemporaneous studies concerning the same research question are faced with a dilemma: whether they would have had justification to start their own study had they known those results. In other words, once the longitudinal study had been published, was there still a state of uncertainty around the study question within the clinical community? If a reasonable clinician could believe some uncertainty remained, then continuation of the ongoing study would be justified.

2.

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3. 4. 5.

ethical guidelines on epidemiological studies [Internet]. World Health Organization; 2009. [cited 2011 Nov 2]. Available from: http://books. google.com/books?id=R3pkPgAACAAJ Rose S. International ethical guidelines for epidemiological studies. Am J Epidemiol. 2009;170(11):1451-2. Rickham PP. Human experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki. BMJ. 1964 Jul 18;2(5402):177. World Medical Association. Declaration of Helsinki [Internet]. 2008 [cited 2011 Nov 2]. Available from: http://www.wma.net/en/30publications/ 10policies/b3/index.html

6. 7. 8. 9.

Ioannidis JP. Why most published research findings are false. PLoS Med. 2005 Aug;2(8):e124. Epub 2005 Aug 30. Ioannidis JP. Why most discovered true associations are inflated. Epidemiology. 2008 Sep;19(5):6408. Malmqvist E, Juth N, Lyne N, Helgesson G. Early stopping of clinical trials: charting the ethical terrain. Kennedy Inst Ethics J. 2011 Mar;21(1):5178. Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):64356.

Some ethical issues here: demands of informed consent and ethical justification for research
PrAVESH JUNG G
Department of Humanities and Social Sciences, IIT-Bombay, Powai, Mumbai, 400 076 INDIA e-mail: pgjung@iitb.ac.in

In this comment, I intend to highlight some of the bases of the ethical concerns behind the study in question (1). I argue that these concerns should be viewed not merely with alarm but also with a sense of urgency for a demand for some ethical imperativeness. The study, I argue, either misreads or downplays the role and significance of certain principles which I posit are fundamental to the framework of medical ethics (the justification for considering these principles fundamental demands a separate essay) The concerns that I raise here are based on two characteristics of the study in question: First, though such studies are labelled observational studies as opposed to controlled experiments, they are not mere armchair introspective observations of ones thoughts. They are carried out in a social space, where the object being observed is an other, rather than the self that is doing the observation. (The researcher-subject dichotomy can be seen as an instance of the self-other dichotomy.) Second, the legitimacy of such a study is derived from the end or the projected result that the study aims to attain. That is to say that the study is not self-justificatory. These two characteristics respectively form the basis for two pivotal demands of medical ethics -- informed consent and ethical justification for research. These twin demands constitute the major challenges pertaining to the ethicality of a research. The paper will briefly deal with these twin demands in light of the study in question.

forth the demand to recognise the possibility of asymmetry of information between the researcher and the participants of the study. The second constituent, consent, sets forth the demand to recognise the principle of autonomy. To accept the possibility of asymmetry of information is to acknowledge the fact that individuals may differ in terms of the scope and extent of information that they possess about the world. The principle of autonomy acknowledges, on the other hand, the view that individuals are ends in themselves, and therefore, have the right to self-determination. To recognise this demand made by the principle of autonomy is to recognise that individuals have the right to choose. However, the principle of autonomy only assures us that all individuals have the right to choose; it does not ascertain that their autonomy also enables them to understand their choices when they actually confront them. In itself, the principle ascertains the attribution of autonomy to an agent at the formal level alone. Therefore, the demand of informed consent brings into operation the related demand for recognising the possible fact of asymmetry of information. The recognition of this possible fact poses a duty for the researcher to provide the necessary information to enable agents to understand the options that they are to choose from. Thus, it is required that the principle of autonomy be supplemented by acknowledgement of the possibility of asymmetry of information. Without this, the autonomy of an agent may merely remain a formal notion without being translated into an actuality. Thus the term informed consent posits two distinct though related demands upon the researcher: the duty to recognise the autonomous status of an individual, and the duty to provide the information that would enable agents to understand their choices and consciously exercise their autonomy. This also provides agents (in this case potential study subjects) the following rights: the right to be treated as autonomous

The demand of informed consent

It is often overlooked that though the term informed consent grammatically operates as a single unit, it is constituted by two terms that signify two distinct, though interrelated, demands. The first constituent, informed, sets

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agents, and the right to be provided information to enable them to understand their choices and exercise their autonomy consciously. Here it is important to recognise that the demands of informed consent do not logically entail a duty for the agent making the choice- who in this case is the potential subject of the study to make an ethical choice, even after the relevant information has been provided. It must also be recognised that any form of coercion or incentive to influence the agents choice would be a breach of the researchers duty to recognise the agents autonomous status and, correspondingly, a breach of the agents right to be treated as autonomous. The confusion resulting in non-compliance of the principle of informed consent in the spirit demanded by the principle, apart from actions due to callousness or sheer ignorance on the part of the researcher, lies in the researchers inability to see informed consent as constituted of these two distinct demands. This is true irrespective of the mode (written or oral) by which informed consent is sought. The confusion worsens due to the mistaken reading of the principle of informed consent to entail a duty for the researcher (the one obtaining the informed consent) to shoulder the moral burden of ensuring that the autonomous agent (the potential subject) makes an ethical choice (Of course this assumes that there can be a determinate ethical choice amongst a range of available choices.) The principle of informed consent does not, and cannot, pose such a moral demand upon the researcher. Doing so would be in conflict with the demand of recognition of the autonomous status of the agent (the potential subject). By and large, I suspect, researchers -- wrongly -- take this to be the duty entailed by the principle of informed consent, while ignoring the actual dual demands of duties placed on them by this principle. If one misreads the principle of informed consent to entail a duty to draw out a specific choice, even if this choice is an ethical one, then upholding this duty would not only breach the duty of recognising the autonomous status of the agent, it would, apart from raising questions about the legitimacy of terming it as a choice of the agent, also legitimise the modification of the demand posed by the possible fact of asymmetry of information by legitimising the extent, scope and nature of the information to be provided to potential subjects. That is to say that it would legitimise withholding, and/or overemphasis on certain information since the researchers duty would be to extract an ethical choice from potential subjects rather than to provide the information necessary to enable them to understand their choices and consciously exercise their autonomy by making a choice, irrespective of the ethicality of the choice made. The study in question, I suspect, confuses the duties entailed by the principle of informed consent with the (fictitious) duty of ensuring that the agent makes a choice that has been predetermined as the ethical choice by the researcher. The consent taken, in the study in question, was informed, to the

extent that it provided the minimum information required to enable the researchers to draw out a predetermined choice from the potential subject, namely, that of consenting to be a part of the study. I assume the researchers thought this was an ethical choice for the potential subjects. Thus in their enthusiasm to uphold a duty that they assumed to be entailed by the principle of informed consent, they actually violated the principle and fell short of fulfilling the actual dual duties imposed upon them by the principle. (This exposition assumes that the researchers had agreed to uphold the principle of informed consent and can be justified by the fact that the researchers took oral informed consents from the subjects. However, the principle of autonomy can be and has been challenged, and subjected to examination through the lens of other principles of biomedical ethics such as beneficence or non-maleficence.)

The demand of ethical justification in research

By and large, biomedical research cannot be self-justificatory (as opposed to say research in pure mathematics, or speculative mathematics, that engage with abstract problems as ends in themselves, though it may be appropriated later by applied research). By and large, biomedical research must answer the question: Why this study? The question itself has two distinct, though related, elements: technical and ethical. The recognition that the ethical aspect of the question is as relevant as the technical aspect, if not more, is the basis for the growth of the field of medical ethics. To recognise that study x is not self-justificatory is to recognise that its justification resides in something other than the study itself -- y, which is the end that the study projects it would achieve in its completion. Hence, the form of such justification is of the nature of a conditional or hypothetical statement (as opposed to a categorical statement). The justification of x is conditional on the justification provided by y for x. The formal structure of these justifications would be: If y, then x stands justified. It is to be noted here that y cannot then derive its justification from x (this would be a fallacious, circular justification). Given the necessary independence of y (the justification for x) from x (the study), y can change independently of x. However, given that x derives its justification from y, any change in y can have a direct impact upon x and the justification it derives from y. This is why, I would argue, the demand of ethical justification of research obliges the researcher to follow developments in research that could change an understanding of the projected end. In the case of the study in question, the end was to understand the relation between cervical dysplasia and cervical cancer; it sought to find out whether the former evolved into the latter and if it did, to develop better therapy to prevent cervical cancer. Thus, when the study was approved by the ethics committee of the research council, the study might arguably have been justified on the basis of this projected end which in itself may be granted a fair review.

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However, as already discussed, the projected end of a study is independent of the study itself. Thus, when mid-way through this study, the north American medical journal published the results of another longitudinal study of cervical cancer, concluding that cervical dysplasia was a precursor for cervical cancer, and thus all forms of dysplasia warranted treatment, the projected end of the study under question was achieved. The publication would invalidate the justification of this study, and consequently its ethical justification. However, one could still have argued for the continuance of the study on other grounds. One such ground might be that the researchers were ignorant of the study published in the north American medical journal. However, if this were so, it would raise serious concerns regarding their credibility given the nature and potential social impact of their research. It would suggest that they breached their duty to take stock of things regularly, a duty posed by the demand of ethical justification and that they overlooked the fact that a change in that which justifies (the projected end) can have an impact, and a crucial one, upon that which is being justified (the study). One could also argue that though the researchers were aware of the other study, they were sceptical about the definitiveness of its findings. Such a sceptical stance is legitimate provided the

scepticism is justifiable. An unjustified sceptical stance would be hollow and unworthy of critical attention. The ethical justification for such a sceptical stance can be based upon the principle of non-maleficence. The studys proponents can justify their sceptical stand arguing that the aforementioned principle entails a duty to ensure that they be certain about the other studys conclusions before accepting them to be a definitive understanding of cervical cancer and its relation to cervical dysplasia. They are duty-bound to do this, so as to ensure that no harm was done (principle of nonmaleficence) to women with cervical dysplasia (possible cases of cervical cancer) by virtue of the conclusion that the study would generate. Though it would be hasty to conclude that no genuine reasons pertaining to the scientific or technical aspect of the published study could have made the researchers sceptical and therefore led them to continue the study, these reasons would have to be brought out and defended. Acknowledgement: I thank all the reviewers for their comments and suggestions.
reference 1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research. Geneva: World Health Organisation 2009;124-5.

A Film on Clinical Ethics

Call for ideas

Clinical ethics remains at the core of the bioethics movement. It is the ethics practiced by clinicians and those in the medical profession at large. However, ethics is not a set of written-down rules and practitioners often have to use their own judgment and discretion, and take critical decisions for the patient. Clinical ethics concerns run the range between questions of decisionmaking, ensuring privacy and confidentiality, taking consent, and negotiating between doing what is in the best interest of the patient, respecting patients judgment and autonomy, considering end-of-life issues and more. Yet, the path to making a decision is not always smooth and often remains marked by dilemmas, anxieties, hesitations and also certainties and triumphs. The Centre for Studies in Ethics and rights (www.cser.in), a premier bioethics research organisation in India that has been researching the various aspects of clinical ethics, invites creative minds to make a film on any aspect of clinical ethics in an Indian context a documentary, a montage or a creative mix from footage archives! Purpose of the film: The film would form part of the syllabus for the medical humanities course for doctors. The tentative budget for the film will be 2.5 lacs (inclusive of all expenses borne by the director), provided in three installments. We would want the finished film in 90 days from the date of the first installment. To apply, please send the following:
l A concept note (maximum 500 words) mentioning the duration of your film, l A break-up of the budget l Your CV (and the CVs of other personnel who might work with you).

to clinicaletics.cser@gmail.com before January 31, 2012. For any queries that you might have, mail Deapica at clinicalethics.cser@gmail.com .................... Join us on this exciting journey of translating philosophy into a visual narrative ...........................

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seleCted sUMMarY

William Oslers medical ethics in the 21st century

rICHArD L GOLDEN
State University of New York at Stony Brook; Curator, Osler Library, McGill University, Montreal, Quebec H3A 2T5 CANADA e-mail: r.golden@pol.net

Mark W Millard. Can Osler teach us about 21st-century and pathology in the laboratories and clinics of London, Berlin, medical ethics? Baylor university Medical Centre and Vienna. Returning to McGill he quickly rose to become Proceedings. 2011; 24(3) 227-35. Professor of the Institutes of Medicine and with an ever growing reputation went on to successive professorships at the medical The ineluctable allure and wisdom of Sir William Osler, which faculties of the University of Pennsylvania (Philadelphia), Johns now spans three centuries, is elegantly put to the test by Hopkins University (Baltimore) where he served as the first Mark Millard in determining its applicability to the medical Physician-in-Chief of the Johns Hopkins Hospital, and capped ethics of the 21st century. While there is little doubt that our his career as Regius Professor of Medicine at Oxford University; current technical knowledge and capabilities will be regarded an unprecedented journey spanning two continents and as primitive by the end of the century, if not well before its three nations. It was at Johns Hopkins that he published midpoint, how will our current ethical standards be viewed? his renowned single-authored textbook, The Principles and Are the teachings of William Osler, the preeminent physician of Practice of Medicine, that went through 16 editions (1892-1947) his time, applicable to modern ethical dilemmas? encompassing over 500,000 copies and influencing successive The author raises the issues of treatment of irreversible illness; generations of students and practitioners. Its influence was not medical error and patient awareness; disagreement among limited to the English-speaking world which saw American, consultants; and third-party payers limiting access, continuity of British, Australian and Indian (Calcutta) editions, but had a care, or denial of service. He further cites a survey of physicians global impact as a result of translations into Russian, French, that selected as major problems those of the incompetent or German, Chinese, Spanish and Portuguese (1). impaired colleague; confession of medical error; physicianOsler had over 1,600 publications including books, articles and patient confidentiality in couples when one partner is HIV essays on medical, philosophical, historical, educational and positive; the prolongation of futile care in a terminal patient; biographical topics. His enduring influence rests on a legacy denial of care to those who cannot pay; whether to honour a of clinical, scientific, literary, educational and intra-professional familys request not to tell a patient that he/she has a terminal achievements, linked to the lodestone of a remarkable disease; exaggerating a patients condition to obtain insurance personality, and bound together by ethical principles and an coverage; and writing prescriptions for friends or family extraordinary humanism. members. In considering William Oslers medical ethics, we must A hierarchy of ethical principles is cited that offers guidance: acknowledge that in many ways he was a man of his patient autonomy (the right to refuse treatment); beneficence Victorian-Edwardian times, but tempered by his historical and (the adjuration to do good); non-maleficence (the instruction philosophical studies and an innate humanism that left him far to do no harm); and justice (both doing the right thing and ahead of his time and remarkably free of prejudice. His cousin, ensuring distributive fairness); ethical principles that include Norman Gwyn, commented that the seed of prejudice must the right to know and informed consent, differing from the have fallen on stony ground in Sir Williams case... (2). Osler paternalistic beneficence of earlier times. The caveat is given declared: that the rank, order, and definition of these ethical principles are subject to temporal interpretation and may change from What I inveigh against is a cursed spirit of intolerance, one era to another. Examples are cited of Oslers teachings conceived in distrust and bred in ignorance, that make the and personal approach to some of these problems, including mental attitude antagonistic, even bitterly antagonistic, euthanasia and assisted suicide, and the economics of medical to everything foreign, that subordinates everywhere the practice. race to the nation, forgetting the higher claims of human brotherhood (3). William Osler (1849-1919), the foremost physician of the English-speaking world, was born in Bond Head (Ontario), In a more pithy statement he proclaimed: The great republic of Canada, one of the nine children of an Anglican clergyman. medicine knows, and has known no national boundaries. This After graduating MD from McGill University (Montreal) he spent is the heartening theme of todays altruistic Doctors Without the usual wanderjahre in Europe, honing his skills in medicine Borders (4).
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Humanism in its broad sense was not part of the idiom of Oslers time, although its concept was well known. It is a word that is often glibly used and difficult to define. Osler was once questioned as to why he merrily whistled after leaving the bedside of a gravely ill patient. He revealed the depths of his humanistic empathy in responding: I whistle that I may not weep. (5) Another poignant example occurred during Oslers Oxford tenure when he was called to the home of a colleague to see a child with very severe whooping cough and bronchitis, unable to eat and wholly unresponsive to the blandishments of parents and devoted nurses alike. Clinically it was not an abstruse case, but weapons were few, and recovery seemed unlikely. Osler, on his way to graduation ceremonies in his academic robes, stopped and saw the child and after a brief examination peeled, cut, and sugared a peach which he fed bit by bit to the enthralled patient. Although he felt recovery was unlikely, he returned every day for the next 40 days, each time dressed in his robes, and personally fed the small patient some nourishment. In a short time the tide began to turn and recovery became evident (6). This is humanism that is readily understood on a visceral level. Oslers medical ethics derived in part from his upbringing as the son of a clergyman, his early mentors, his philosophical and historical studies, and his fascination with the concepts and principles of the ancient Greeks from whom he embraced the Hippocratic philanthropia and philotechniathe love of humanity coupled with the love of his craft. (7) Osler particularly adopted the lessons and standards of the Hippocratic Oath and its ethical obligations. While the spirit of the Oath remains intact, a newer Declaration of Geneva now embraces some more modern concepts. He often quoted from Poe of the glory that was Greece, and the grandeur that was Rome. (8) Among Oslers aphorisms and postulates he inveighed: You are in the profession as a calling, not as a business; as a calling which exacts from you at every turn selfsacrifice, devotion, love and tenderness to your fellow man. (9) Distinctions of race, nationality, colour, and creed are unknown within the portals of the temple of Aesculapius. (10) No one should approach the temple of science with the soul of a moneychanger. (attributed to Sir Thomas Browne) (11) Care more particularly for the individual patient than for the special features of the disease. (12) At a farewell dinner in New York in 1905, before leaving to assume the Regius Professorship in Oxford, he candidly discussed his ethics (13) (quoting Matthew Arnold) confessing: I have made mistakes, but they have been mistakes of the head not of the heart. I can truly say, and I take upon myself to witness, that in my sojourn among you: I have loved no darkness, Sophisticated no truth, Nursed no delusion, Allowd no fear! (14)

There is no doubt that, in general, Sir William Oslers ethical standards and approach to the practice of medicine remain pertinent and fresh. In a world where doctors have become providers and patients consumers; where cost containment and third party payers limit choices; where access to medical care is limited or non-existent, and life-saving drugs marketed at egregiously high cost, the example of Osler and virtue ethics are a beacon in an evolving, and frequently, disturbing practice of medicine. Listen to Oslers own words: I have three personal ideals. One, to do the days work well and not to bother about to-morrowThe second ideal has been to act the Golden Rule, as far as in me lay, towards my professional brethren and towards the patients committed to my care. And the third has been to culture such a measure of equanimity as to enable me to bear success with humility, the affections of my friends without pride and to be ready when the day of sorrow and grief came to meet it with the courage befitting a man. (13) For those who wish to learn more of William Osler and his ethics than can be offered in this brief review, read Dr Millards insightful article and then, if the spark successfully ignites the kindling of intellectual curiosity, proceed to the delightful biographies of Michael Bliss (15) and Harvey Cushing (16).
references 1. Golden RL. A History of William Oslers The Principles and Practice of Medicine. Montreal: Osler Library, McGill University and the American Osler Society; 2004. Gwyn NB. The boyhood of Sir William Osler. CMAJ. 920:10:24-7. Osler W. Chauvinism in medicine. In: Aequanimitas with other addresses to medical students, nurses and practitioners of medicine. Philadelphia, Pa: P Blakistons Son and Co; 1906: 277-306. Osler W. The importance of post-graduate study. Lancet. 1900; ii:73-5. Osborne M. Recollections of Sir William Osler. Int. Assoc. Med. Mus. Bull. 1926; 9: 171-4. Mallam P. Billy O. JAMA.1969;210:2236-39. Osler W. The old humanities and the new science. Boston and New York: Houghton Mifflin & Co;1920:63-4. Poe, EA. To Helen (1846 revision). In: The Raven and Other Favorite Poems. Mineola, NY: Dover Publications;1994:12. Osler W. The reserves of life. St. Marys Hosp Gazette.1907;13:96-8. Osler W. British medicine in Greater Britain. In: Aequanimitas with other addresses to medical students, nurses and practitioners of medicine. Philadelphia, Pa: P Blakistons Son and Co;1904:167-96. Osler W. Valedictory address to the graduates in medicine and surgery, McGill University. Can Med Surg J. 1874-1875;31:433-42. Osler W. Address to the students of the Albany Medical College. Albany Med Ann. 1899;20:307-9. Osler W. LEnvoi. In: Aequanimitas with other addresses to medical students, nurses and practitioners of medicine. Philadelphia, Pa: P Blakistons Son & Co;1906:467-74. Arnold M. Empedocles on Etna. In: The poems of Matthew Arnold, 18401867. London: Henry Frowde, Oxford University Press; 1909:124. (Act II, Lines 400-403). Bliss M. William Osler: A Life in medicine. New York: Oxford University Press; 1999. Cushing H. The life of Sir William Osler. Oxford: Clarendon Press;1925.

2. 3.

4. 5. 6. 7. 8. 9. 10.

11. 12. 13.

14.

15. 16.
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reviews

Book review: Back to the future

DHrUV MANKAD
Director VACHAN, Nashik 422 002 INDIA e-mail: dhrvmankad@gmail.com

Anand Zachariah, r Srivatsan, Susie Tharu, editors, on illnesses ranging from malnutrition to depression? behalf of Christian Medical College and Anveshi Collective. Towards a critical medical practice: reflections on the The essays discuss five central themes: dilemmas of medical culture today. Hyderabad: Orient l The dichotomy between modern medical knowledge, whose Blackswan; 2010. Pp 392 ISBN 978-81-250-4091-0 495.00 perspectives and content are influenced or determined by the state, and medical practice. This leads to frustration, We have been on the threshold of transition in our health burnout and even conflict between doctors and patients, status and healthcare system for the past 64 years. The infant or between government protocols and the need to tailor mortality rate has been reduced substantially. However, the treatment to the patients needs; declining sex ratio points to the widespread practice of sex selective abortion. There has been no change in the body mass index of children and women, which points towards a looming epidemic of hunger. The health infrastructure has improved but its utilisation by the poor has not. There is greater availability of state-of-the-art technologies and trained human power for treating patients. But is it relevant, affordable and based on the needs of sufferers? Are the number and quality of healthcare services - public and private- appropriate? What are the historical, political, cultural and ethical dimensions of these problems? Towards a critical medical practice: reflections on dilemmas of medical culture today explores the answers to these questions, looking at them through the lenses of the knowledge, attitudes and experiences of medical academicians and practitioners. The book is based on a consultation on medical education; doctors concerned about the structure of medical knowledge participated in a consultative process for improvement in medical education initiated by Christian Medical College, Vellore. The non-governmental organisation Anveshi was an observer in this process. The book is a result of critical discussions about history, culture, institutions, the assumptions behind medical theory and practice, and the dimensions of a crisis of medical knowledge. The introduction is a discussion of the ethical dilemmas in medical practice as presented by Anand Zachariah and R Srivatsan through two cases. These frame the fundamental ethical dilemmas that teachers-activists-researcherspractitioners face. Some of the questions that emerge from these two cases will have been asked by all medical providers. What was the best line of treatment: by a general physician or by an expert? What did the patient desire? Was the clinical diagnosis appropriate? Did a new protocol have to be applied for each patient? Who is responsible for avoiding exposure to the environmental causes of illness? What is to be done when social determinants like poverty are the main causes of
l The dichotomy between medical technologies transplanted

from the West, with doctors trained in their use in sophisticated tertiary care hospitals, and the doctors inability to apply their knowledge in less sophisticated, even rudimentary settings;
l The dichotomy between curative care services and public

health services in India that sends most doctors to private hospitals in India or abroad since these are in line with their backgrounds and the investment they have made in their education;
l The dichotomy between diseases and their manifestation

in India and their presentations in classical (western) medical education, that leads to innovative and inexpensive diagnostic and treatment methods; and
l The dichotomy between medical knowledge and its day-to-

day practice. While such dichotomies exist in reality, my contention is that the dilemmas remain even if one takes a patient-centric view. Some examples of such dilemmas are: 1. Do people give their consent to choose an appropriate treatment source? Do poor patients approach unqualified practitioners out of choice or out of compulsion because there is no other affordable option? 2. Whose interest is served when a patient is treated at a primary care centre by a general physician and not by an expert? Should the clinician have the autonomy to use a trial and error method that takes into account the patients context, in place of a well-tested clinical guideline that is developed elsewhere? 3. Who benefits from cost reduction in a private healthcare setting? Did the private hospital profit by cost reduction, using comparatively cheaper humanpower (such as employing paramedics, who are paid less, rather than medical staff ) and treatment protocols (fewer investigations, fewer staff per patients, fewer services)?

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4. Conflict of interest: What is the interest of the various stakeholders involved in deciding the types of public health measures to be introduced? This is particularly important when the model is competing with another one which has the same intention. 5. Policy and guidelines as coercive documents in practice: If a guideline generated by the government of India loses its guiding nature and becomes a mandatory clinical order then it is certainly a violation of the principle of formal justice of applying it as per the patients need. In essence, the book is a rich source of theoretical perspectives

and practical examples, taking the readers back into the history of medical science and the political and cultural context of problems of public health in India. The perspective and lessons of the book are essential if our society is to avoid the pitfalls in the future course of medical technology and public health. One may have expected more guidelines, solutions and preventive steps for health practitioners, to tackle the ethical dilemmas they face in medical practice. However, the authors have done an important job in emphasising the complexities and dilemmas of decision making in such situations, and this point is made in the title itself.

Film review: Medical students as guinea pigs

VIVEK JAIN1, rASHMI NAUDIYAL 2
1

Vardhman Mahavir Medical College and Safdarjung Hospital, Safdarjung, New Delhi, Delhi 110 029 INDIA e-mail: docvivekjain@gmail.com 2 Senior resident, Department of Paediatrics, ESI Hospital, Department of Paediatrics, ESI Hospital, Sector-15, rohini, Delhi 110 085 INDIA

404 Error not found. Producers: Nameeta Nair, Kapil Mattoo, teachers, including the lecturer wife of Professor Aniruddh 2011. Director: Prawaal raman. Hindi, 114 minutes. himself Dr Mira (Tisca Chopra) and Professor Vaidya (Satish Kaushik), try their best to restore his sanity, the hapless student Developing countries like India and Sri Lanka are trying to gets ever more deeply involved in the clash between illusion tackle the problem of ragging the practice, in educational , and reality. The egotism of Professor Aniruddh, coupled with institutions, of senior students bullying new students. The problem is more noticeable in medical colleges in India where his desire to rationalise paranormal activity, ultimately drives it has assumed serious dimensions with psychological, physical Abhimanyu to the point of no return. and sexual harassment. 404 Error not found is a film that tries to offer an insight into this menace and its impact on its victims. There is a sub-plot regarding a psychiatry teacher with bipolar disorder who attempts to use one of his students as a guinea pig for its cure. The reference to paranormal phenomena adds another dimension. One key issue viewers, especially medical professionals or students, cannot afford to miss is the discussion of ethics. The male protagonist, Abhimanyu (Rajvvir Aroraa), is a bright new medical student who daringly volunteers to stay in Room 404, the infamous haunted room of the college hostel. His self confidence and determination seem admirable and his teacher, Professor Aniruddh (Nishikant Kamath), is impressed with Abhimanyus efforts to promote rational science among his fellow students. Meanwhile, Abhimanyu has to face the wrath of his seniors for defying their bullying, and starts to lose his mental composure. He begins to see the spirit of Gaurav, an earlier occupant of Room 404 who had committed suicide in that very room. Professor Aniruddh, who, incidentally, himself suffers from bipolar disorder, decides to use Abhimanyu as his guinea pig to prove to the world that there is no such thing as paranormal activity. He involves Chris (Imaad Shah), a senior student of the college in his sinister plans. As Abhimanyus The movie raises several key ethical issues in medical practice. Professor Aniruddh fails to respect the autonomy of Abhimanyu, the individual, and his ability to make decisions with regard to his own health and future. He acts in total disregard of the principle of beneficence, as well as the prohibition on maleficence, both key principles of medical ethics. Abhimanyu does not give his voluntary consent to being the study subject for the experiment. As far as biomedical research is considered, the professor does possess professional competence to conduct such an experiment but he is not able to justify how he minimised the risks involved for the subject. He tries to rationalise his actions by saying that he was acting to maximise public interest, but is unable to establish transparency and total responsibility. Although the film tries to deal with too many issues in a short span of time, it is realistic in its portrayals. Powerful performances by the actors force viewers to empathise with both victim and perpetrator, at one point or the other. Long after its unexpected climax, one continues to think about the issues raised by the film. It manages to highlight abhorrent practices such as ragging and unethical human experimentation in the field of medicine.

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FroM otHer JoUrnals

Out-of-pocket health expenses and Indias poor

Out-of-pocket (OOP) expenditure in health is a major component of the household expenditure of health service users, and a source of concern especially for developing countries like ours. In India the structural adjustment programmes of the 1990s led to the central and state governments limiting the funding for the social sector. User fees were introduced in the public healthcare sector in the 1990s. Despite progressive efforts like the Drug Price Control Order which was meant to ensure affordability of some commonly used drugs, liberalisation, including liberalisation of the pharmaceutical sector in 2002, has sent prices spiralling upwards. When 90% of the population has no health insurance coverage, rising prices have left a large number of people unable to access healthcare. These policy changes, along with growing poverty nationwide, have stretched the spending capacities of poor Indians. The author uses quantitative data from various national surveys to measure the extent to which household living standards have been affected, across income groups and states. It is found that the richer states have an increased OOP expenditure for healthcare, and the overall OOP expenditure for healthcare has increased over the past one decade. However, this increase is primarily due to higher expenses among the rich. This emphasises the fact that the poor must choose between medical care and other essentials such as food.

has been done to provide useful inputs at the policy level. The author points out that along with recording the success stories of PPPs in primary healthcare, it is equally important to look into the failures. Through implementation research it is essential to explore the mechanisms through which it works or does not work. The author establishes the importance of scientific evaluation and evidence of what works for whom and under what conditions, rather than just focusing on whether or not it works. This will help formulate more innovative policies in this field. Prashanth NS. Public-private partnerships and health policies. Econ Pol Wkly. 2011 Oct 15;46(42):13-5.

Should doctors recommend kidney donation?

Kidney transplants are required for persons suffering from end stage renal disease or acute renal failure. Due to increasing public awareness, the availability of kidneys from deceased or live donors has increased somewhat, but the demand for kidney transplants still far outstretches the supply, and many patients with renal disease die while waiting for a transplant. To meet this demand and for better acceptability of the recipient, doctors may sometimes encourage their patients to donate their kidneys while alive, as living donors to a stranger. ,

The risk of death associated with kidney donation is minimal (1 in 3,000). Other risks are post-operative complications and a reduction in renal function. Younger donors are able to recover Ghosh S. Catastrophic payments and impoverishment due faster, and the remaining kidney can more than compensate for to out-of-pocket health spending. Econ Pol Wkly. 2011 Nov; the lost one. 19(25):63-70. Since the doctor-patient relationship is paternalistic, patients

Evidence-based policy and healthcare models in India

In this article the author, who has been part of a successful public private partnership (PPP) model in healthcare, discusses the importance of implementation research in developing a successful model of PPP in healthcare. In his experience, the key to success lies in innovations. This is evident in healthcare PPPs in India through community health insurance, mental healthcare at primary health centres (PHCs) through trained doctors, tele-electrocardiography services, mainstreaming traditional medicines and availability of staff. The state should also ensure its active participation in the process. In many parts of India PHCs are not used either because they are too far away or because their service delivery is of poor quality. In this situation, it is easy to opt for a partnership between the state and the private sector in which the latter provides partial or full support to need-based primary healthcare services, or even to emergency obstetric care. Though the involvement of the private sector has gained importance among policy makers in India, very little research

may feel that whatever the doctor advises them is good for them. In such a situation it is easy for doctors to misguide their patients or not provide full information about the pros and cons of living donation, thereby leading patients to opt to donate, without knowing the consequences. Doctors should not recommend that their patients donate, for the simple reason that it may affect the post-operative life of the donor. The primary responsibility of doctors is to do no harm to their patients. In order to do good to one patient, they should not harm another. A healthy individual can express the autonomy to donate one kidney to a stranger, but this should not be the result of coercion by the doctor. Glannon W. Is it unethical for doctors to encourage healthy adults to donate a kidney to a stranger? Yes. BMJ. 2011; 343 doi: 10.1136/bmj.d7179

Shielding healthcare workers from TB

Tuberculosis is a major public health problem in India, and this is also a problem faced by healthcare workers. Doctors and nurses get exposed to TB early in their clinical rotations, and

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infection can progress into full blown TB during the course of their work. Nursing trainees are at the highest risk because they are at the bedsides of patients in overcrowded wards. The incidence of TB among healthcare workers is much higher in developing countries than in developed countries. The prevalence of latent and active TB is much higher among healthcare workers than in the general population in the same area. Isoniazid preventive therapy (IPT) is recognised as an essential component of TB infection control. IPT programmes targeted at younger healthcare workers have worked better to prevent active TB. This paper suggests that tuberculin skin testing of doctors and nurses be done on an annual basis. Those who have contracted the disease can be started on a dose of IPT after ruling out active TB disease. Preventive therapy should be monitored by experienced doctors and follow-up should be regularly done, with monitoring for adverse reactions to treatment. Further, maintaining hygiene, ventilating TB wards, and isolating TB patients would go a long way in controlling the spread of TB.

of maternal health, states have launched a range of PPPs to tackle maternal mortality. However, many of these programmes have failed, and this article analyses the reasons for these failures: the barriers posed by user fees, the lack of specialised facilities and services such as blood banks, no provision for tackling emergencies in obstetrics, and an imbalance in the geographical distribution of services. Further, in the PPP model the balance of power between the public and the private partners is often tilted in favour of the latter, and the former becomes a marginal player. This adversely affects service delivery. Regular assessments have not been conducted for most PPPs, and there is a lack of transparency as to their effectiveness. The article stresses the urgent need for regular and proper evaluation of the nature and quality of PPPs before they are replicated by other states. It also calls attention to the need for these systems to be accountable to the general public. ravindran STK. Public-private partnerships in maternal health services. Econ Pol Wkly. 2011 Nov 26-Dec 2:43-52.

raj r, Prasad H, Arya BK, Bhattacharya SD. Isoniazid There is much discussion on the need for revamping the preventive therapy programmes for healthcare workers current medical education sector in India. The authors discuss in India: translating evidence into policy. Natl Med J India. concerns related to the use of true/false examination formats 2011;24(4):101-7. to assess the knowledge of students in medical examinations. They point out that when candidates choose the answer Somalias struggle for basic healthcare from two options, there is a high probability of guesswork This report paints a grim picture of the realities faced by Somalis being used. This considerably reduces the reliability of the and the helplessness of international aid organisations working test and the assessment of the real knowledge of the student. in conflict zones. The civil war raging in Somalia since 1991 The authors suggest that even awarding negative marks for has impoverished the country so much that even basic health incorrect answers may not resolve the problem; punishments services are a luxury. The drought in the region has pushed the do not aid in modifying behaviour and may instead add to population further into a state of despair. Migration, fuelled by students confusion about their performance. The true/ false the conflict, to neighbouring countries and to relatively stable question answer format rewards students for taking risks, areas within the same country, has resulted in overcrowded which is unwarranted. The system also fails to understand the refugee camps which act as a hotbed for infectious diseases. ability of the student to judge and resolve a particular clinical Emergency assistance is always delayed. The health system is situation. in a shambles and the lack of routine surveillance data makes the implementation of preventive and control measures all Alternative systems of assessment such as the Single Best the more difficult. The efforts of international agencies are the Answer (SBA) and Extended Matching Items (EMI) systems only source of support in the area. There is an urgent need for are also discussed in the article. Both these systems provide people to overcome political differences and mistrust, and a greater number of options to choose from, which reduces reach out to a nation and her people who are struggling for the probability of guesswork. They test students cognitive abilities better. They also distinguish between high and low their survival and basic human rights. performers more accurately. While the true /false method Carbol JC. War, drought, malnutrition, measles- a report has the advantage of covering a lot of content with fewer from Somalia. N Engl J Med. 2011 Nov 17;365(20):1856-8. questions it is also less reliable and fails to capture the level of understanding of the student.

Change needed in medical examination formats

Public-private-partnerships in maternal healthcare

Healthcare policy in India encourages the public-privatepartnership (PPP), with the state or no-profit agency tying up with a private/profit-making agency to disburse healthcare. The National Rural Health Mission specifically talks about the importance of such schemes. States have entered into different partnerships to provide tertiary and specialised care. The PPP may be set up as a contract, as a voucher scheme, or as networks and social franchises between partners. In the area

Madawa C, Margery D, Gominda P. Assessment of medical knowledge: the pros and cons of using true/false multiple choice questions. Natl Med J India. 2011;24(4):225-8.

Confidentiality, autonomy and beneficence

The case study and commentaries look into the issue of confidentiality and its breach in the patients best interests. It describes the decision of a patient to undergo surgery in

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another country against her physicians strict instructions, in the hope that this will improve her quality of life. To complicate matters further, the efficacy of the procedure has not been fully proven. Now back in her home country, with her original physician, she chooses to disclose the information to the physical therapist of the medical team treating her. The therapist now faces the dilemma of whether or not to reveal this information to the treating physician. Revealing this information may breach the confidentiality of the patient. However, not revealing it may cause complications in the treatment and harm the patient. Lalibert M argues that the decision of the patient to withhold the information from her physician should be respected if there are no imminent and life-threatening complications that could arise out of the foreign procedure and if the patient is competent to take the decision to undergo that procedure. The author further points out that a breach of confidentiality would endanger the patients trust in the medical team and could force the patient to discontinue her treatment altogether. Lantos JD and Gowda S suggest that the foreign treatment might warrant certain changes in the present treatment plan and in such a scenario,

the patients safety should be the primary concern. They also note that it is necessary to consider the relationship between the physician and the patient. Lantos and Gowda also suggest an alternative: the therapist can reveal the information to the physician who can make necessary alterations in the treatment regime and not inform the patient about the disclosure. The best route would be to encourage the patient to reveal the information to her treating doctor, or take her consent to reveal the information to the physician. Lalibert M, Lantos JD, Gowda S. Confidentiality and its limits. Should one member of a medical team keep a patient secret from the rest? Hastings Cent Rep. 2011 Nov- Dec;41(6): 12-3.

Contributions from Bhasyati Sinha, Rakhi Ghoshal, Divya Bhagianadh, Mahua Ray and Sweta Surve Compiled by Divya Bhagianadh e-mail: drdivyabhagianadh81@gmail.com

Join IJME on FaceBook and Twitter

As we move into the 20th year of publication, we plan to use social media to engage more actively with our readers and supporters. We have initiated a Facebook group (http://www.facebook.com/groups/IndJMedEthics/) which will be used as a platform to discuss the content from the journal and issues of relevance to bioethics in our context. We urge our readers who are on Facebook to join the group and initiate and participate in the discussions. We also now have a Twitter account: @IndJMedEthics; please follow us to get regular updates on journal content and news of interest in bioethics.

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letters

Universal Immunisation Programme

This refers to a very thought-provoking article by Jayakrishnan (1). I fully agree with the statement, Immunisation matters are left to manufacturers and international organisations, to guide and decide what is to be introduced in our market.(1). There is an acute need to protect adolescents and young adults from the economically poor sections against pertussis and diphtheria. In 2008, the Indian Academy of Pediatrics Committee on Immunisation (IAPCOI), in the consensus recommendations on immunisation, stated: There is no reason to believe that the disease burden of pertussis is low in adolescents in India. A safe and efficacious vaccine is available. The IAPCOI , therefore, recommends offering Tdap vaccine instead of Td/TT vaccine in all children/adolescents who can afford to use the vaccine (2). Tdap contains acellular pertussis antigen, and is very expensive (MRP Rs 699) while Td costs Rs 10.08 only. In 2006, the author and a colleague had suggested the use of a reduced quantity of the whole cell pertussis component (3). Adolescents and young adults belonging to the weaker economic groups are more prone to infections, but they would not be able to afford such a costly vaccine. On November 5, 2008, this author had written to the Serum Institute of India, a leading vaccine manufacturer, with copies to the convener, IAPCOI and other functionaries of the IAP, to take the initiative and come out with a combination vaccine of tetanus with reduced quantity of diphtheria and whole cell pertussis components. This is needed for the masses that also need protection against pertussis but cannot afford the current Tdap vaccine. There was no response from any one. However, the drug manufacturers alone are not at fault. Under the existing system, tetanus toxoid with reduced quantities of diphtheria antigen and whole cell pertussis antigen is considered as a new molecule, and needs to be studied afresh for safety and efficacy before even applying for a licence. All this would require heavy investment, while the permitted price cannot exceed that of the DTP vaccine. This will discourage any manufacturer to go for a vaccine which may be the need of the hour but is bound to act as a loss incurring venture. The solution to bail out industry should come from the authorities and the medical profession.(4) Regarding the administration of hepatitis B vaccine, I quote from a 2007 publication of Jan Swasthya Abhiyan which maintains Considering the low prevalence of hepatitis B, and the resource constraints, this vaccine should be limited to babies born to hepatitis B+ mothers. For this purpose, all pregnant women should undergo testing for Hepatitis B as part of other tests for anaemia and blood grouping. This does not require any additional effort or equipment and the test kit can be bought in bulk by the government for, say Rs 15-20. (5).

In 2000, I had stated, Checking of HBs Ag status is not a very expensive or difficult procedure. If it is checked for the prospective marriage partners, the problem of horizontal and later vertical transmission of the virus to the new born can be eradicated (6). I had emphasised the importance of blood testing by stating: If a person is already infected, administration of the vaccine (by routine schedule) will not alter the course of the disease. The infected person may act as a source of infection, while having the false assurance that he or she has been immunised against hepatitis B disease(6). This point was raised since, sometimes, hepatitis B vaccination is carried out as a campaign, providing vaccine free or at subsidised cost. I fully agree with Dr Jayakrishnans views that the national vaccination policy should be disease-oriented. In addition, it needs to be stressed that tuberculosis, measles, polio, diphtheria, tetanus, pertussis, and typhoid should be given priority before including hepatitis B, haemophilus b influenzae, pneumucoccal and varicella diseases in the National Immunisation Programme.
references 1. 2. Jayakrishnan T. Newer vaccines in the universal immunisation programme. Indian J Med Ethics. 2011 Apr - Jun;8(2):107-12. Indian Academy of Pediatrics Committee on Immunisation (IAPCOI). Consensus recommendations on immunisation 2008; Indian Pediatr. 2008 Aug; 45(8):635-48. Paul Y, Marwah P. Immunisation in adolescents. In Recent Advances in Pediatrics, Special Volume 17, Adolescence Gupta S, Bhave SY, , editors. New Delhi: Jaypee Brothers Medical Publishers (P) LtdIndia;2006:35670. Paul Y. Legacy of Jenner and Pasteur needs to be carried forward. Journal of Pediatric Sciences [Internet]. 2010;5;e43 JSP1 to JPS6. Available from: http://www.pediatricsciences.com/ojs/index.php?journal=jps&page=a rticle&op=view&path%5B%5D=131 Universal Hepatitis B vaccination. In National Coordination Committee, Jan Swasthya Abhiyan. New technologies in public health-who pays and who benefits? JSA. 2007 Jan; 41-57. Paul Y. Is Hepatitis B immunisation necessary for all? Indian J Pract Pediatr. 2000;2:188.

3.

4.

5.

6.

Yash Paul, Consultant paediatrician, A-D-7, Devi Marg, Bani Park, Jaipur 302 016, INDIA, email: dryashpaul2003@yahoo.com

Saving lives, or styling them?

The past few years have witnessed the rise of highly publicised lifestyle drugs. They are used to alter our appearance, physical and mental capabilities, the effects of aging, and so on. As the

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availability of a treatment can convert a lifestyle wish into a health need, the pharmaceutical industry becomes a key player in the process of medicalisation, where normal conditions get pathologised. It appears that when drug therapy is available, physicians are less willing to consider non drug treatments, even when there is no evidence that the former is superior (1). One reason is the pressure from the pharmaceutical industry. One example is the use of Orlistat for treating obesity. Although people taking Orlistat lose a little more weight than those controlling their dietary intake (about 8.9% with pharmaceutical aids vs. 5.6 % with placebo over 1 year), there is no evidence that the drug is any more effective than diet in reducing the morbidity and mortality due to obesity(2). Orlistat is available in India and the prices range from Rs 95 to 390 for 10 tablets. Its reported adverse drug reaction (ADR) varies from mild to severe like oily spotting, increased bowel movements, abdominal pain, headache, rashes and severe liver damage (3). A number of anti-aging drugs are now available in the market. One of them is Botulinum toxin type A, used for ironing the wrinkles on the face and neck. It can produce paralysis of the small muscles of the face by blocking cholinergic transmission (4). While there is doubt about the benefits of many modern lifestyle drugs there are also concerns about how the , pharmaceutical market operates. Drug development is often driven by potential profitability rather than by public health needs. Once a drug is available, industry campaigns may seek to redefine the illness in the minds of doctors and potential patients, converting wishes into healthcare problems that require treatment. In India where preventable and treatable diseases like malaria and tuberculosis thrive and kill millions of people and many new diseases emerge without any known treatment, the drug development is skewed towards unimportant lifestyle drugs . The increasing use of lifestyle drugs raises, among several others, one pertinent question: are we trying to homogenise society? There is a need to study the concept and impact of these drugs on society particularly in India. India needs to focus more on life saving and essential medicines rather than lifestyle drugs In a free market system, profits may not be the . best indication of what drugs we need as a society.
references 1. 2. Everitt DE, Avorn J, Baker MW. Clinical decision-making in the evaluation and treatment of insomnia. Am J Med 1990;89:357-62. Therapeutic letter. New drugs V [Internet]. Therapeutics initiative. 2000 Apr 13 [cited 2011 Dec 30]. Available from: www.ti.ubc.ca/pages/ letter34.htm US National Library of Medicine. Orlistat: MedlinePlus drug information [cited 2010 Sep 10]. Available from: http://www.nlm.nih.gov/ medlineplus/druginfo/meds/a601244.html Jeeja MC. Botulinum toxin. Its cosmetic applications. Paper presented during CME on Cosmoceutical pharmacology at Medical College Thrissur. 2009 Oct 23.

Department of Community Medicine, Government Medical College, Calicut 673 008 Kerala, INDIA e-mail: jayanjeeja@yahoo. co.in

Ethics in animal experiments

Ethics is very important to any research. Authors are expected to report if the research was done in an ethical manner. Various studies have highlighted the fact that reports of research involving human participants do not always give adequate information on ethical aspects of the study, such as how informed consent was obtained, and details of the ethics review (1-3). This has been reiterated in studies on articles published in Indian medical journals (4-6). While reporting of ethical parameters in clinical studies is discussed widely, the issue of ethical reporting in animal studies seems to have been ignored. The present study was designed with the primary aim of analysing the reporting of ethical parameters in animal studies published in Indian journals. The secondary aim was to compare the reporting of ethical parameters between Indian and international journals. Most animal studies are published in pharmacology journals. Studies published in two leading indexed pharmacology journals, Indian Journal of Pharmacology (IJP) and Indian Journal of Physiology and Pharmacology (IJPP), were selected for the study. The British Journal of Pharmacology (BJP) was selected as a comparator international journal. All the articles published in IJP and IJPP between 2002 and Jan March issue of 2010 were downloaded from the journals websites (www.ijp-online.com, www.ijpp.com). Animal studies published in BJP from 2002 to September 2009 were downloaded from the journals website (http://onlinelibrary. wiley.com/journal/10.1111/%28ISSN%291476-5381). In the case of BJP, articles published after September 2009 were not available for open access. As for IJPP, articles published since 2002 were available on the website. So, to maintain uniformity, all articles published in or after 2002 were downloaded. Only original animal studies were considered for the study. Short communications, research letters and letters to the editor were not taken into account. Of the studies downloaded, 50 animal studies each from IJP and IJPP were selected randomly (by computer-generated random numbers) and 100 animal studies were selected randomly from BJP by the first author. For equal comparison, animal studies only related to pharmacology were downloaded from IJPP. Each author evaluated these animal studies on the basis of reporting of animal ethics committee approval and reporting of ethical guidelines. Discrepancies in evaluation were resolved by consensus. Values were shown in the form of frequencies, and comparison between various ethical parameters between the Indian

3.

4.

Jeeja MC, Department of Pharmacology, Jayakrishnan T,

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journals (IJP, IJPP) and the international journal (BJP) was done with the help of Chi Square test through excel sheet. Our study revealed that 79% of animal studies published in the two Indian journals reported permission from an ethics committee, which is more than the comparator international journal (62% in BJP). Information related to various guidelines was reported more often in BJP (58%) as compared to the Indian journals (38%). Regarding ethics committee approval and information related to ethical guidelines, there was no significant difference between the two journals. Our findings show that reporting of ethical parameters such as institutional ethics committee approval is better in animal studies published in Indian journals as compared to clinical studies published in Indian journals. In a study by Chaturvedi et al of articles published in the Indian Journal of Psychiatry, it was observed that permission from an ethics committee was reported in 25% of the articles (5). In a similar study undertaken for articles published in two Indian paediatrics journals, permission from an ethics committee was reported in 29.5% of the articles (4). In a new guideline ARRIVE (Animal Research: Reporting In Vivo Experiments) for reporting animal studies, authors of articles reporting research are instructed to report on: the nature of ethics review permission; the relevant licence, and the national and institutional guidelines related to the care and use of animals (7). This study shows that though reporting of ethical parameters is better in animal studies as compared to clinical studies, there is room for improvement and authors should be encouraged to report these ethical parameters in the articles. Though efforts have been made by journal editors towards improving the reporting of ethical parameters (8), there is a need for more in animal as well as clinical studies. Young researchers and students working in the field of biomedical research involving animal studies should be trained in ethical aspects of research while conducting experiments and reporting the same in publications. Journal editors and peer reviewers should make sure that information regarding ethical parameters is incorporated in the manuscript.
references 1. Ruiz-Canela M, Gomez-Gracia E. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med. 1999 Apr 8;340:1114-5. Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA. 2002 Jun 5;287:2835-8. Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics. 2006 Dec;32 (12):718-23. Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci. 2008 Apr;62 (4):134-40. Chaturvedi SK and Somashekar BS. Reporting ethical aspects in published research articles in the Indian Journal of Psychiatry. Indian J Psychiatry. 2009 Jan - Mar;51(1):34. Jaykaran, Gohiya S, Gohiya V, Sharma G, Saurabh MK,Yadav P. Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals: a survey. J Pharm Research.2010 Mar;3(2):307-9. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research. PLoS Biol. 2010 Jun;8(6):e1000412. doi:10.1371/journal. pbio.1000412.

8.

Bavdekar SB, Gogtay NJ, Chavan R. Reporting ethical processes: survey of instructions to authors provided by Indian journals. Indian J Med Sciences. 2009 Jun;63(6): 260-2.

Jaykaran, Assistant Professor, Department of Pharmacology, Government. Medical College, Surat 395 001 INDIA e-mail: drjaykaran@yahoo.co.in Preeti Yadav, Associate Professor, Department of Pharmacology, Government Medical College, Surat 395 001 INDIA N D kantharia, Professor and Head, Department of Pharmacology, Government Medical College, Surat 395 001 INDIA

Bridging the ethics gaps

Sir, I have already collected 15 cases in my research project, and have not taken consent from any of the participants. What should I do now? asked a postgraduate student in an ethics committee meeting that I happened to be attending, several years ago. Promptly came the reply from the head of the institution, who also happened to be the chairperson of the ethics committee there: No problem, just go to any patient who is admitted in the ward and take his thumb print on the consent form. This encounter rudely awakened me to the huge gap between knowledge and practice in medical ethics. In keeping with the advances in medical technology, the world has moved forward in the area of bioethics, but in India we are still rooted in outdated concepts. In the four and a half year MBBS course, students cover a very limited ethics syllabus, inadequate in todays context. The course content in ethics at the undergraduate level stresses deontological theories and lacks in applications or skill development. The focus is on the doctor-patient relationship, issues of negligence and the Consumer Protection Act. In other words, medical ethics is taught on the premise that the law is breathing down a medical practitioners neck and one should be careful not to cross the legal boundary. The past decade has seen an astronomical rise in clinical research in India. The lure of money that has inevitably accompanied this has not only attracted human participants from vulnerable populations, as research participants, but also many graduates of medicine or related disciplines, who decide to engage in a career in clinical research. Many of them come from disciplines like homeopathy, and other Indian systems of medicine, besides allopathy. These youngsters lack the exposure to and competence in research ethics. Even principal investigators of clinical trials are not well grounded in the basic issues of research ethics. Often, ethics committees, which give ethical clearance to myriad clinical research protocols involving human subjects, lack qualified or even knowledgeable members. The undergraduate curriculum should be covering areas

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of skill-building in ethics such as identifying ethical issues and violations, and focusing on remedies and ethical case resolutions. Currently, this is not being done. At the postgraduate level, ethical deliberations, end-of-life decisions, ethical conflicts resolution and clinical ethics consultation are not touched upon. To bridge this gap, the Centre for Ethics was established by Yenepoya University, in Mangalore, Karnataka. The first programme launched by the Centre was the Postgraduate Diploma in Bioethics and Medical Ethics, a year-long course with six contact programmes, supplemented by projects, online assignments and group discussions, culminating in a summative written exam. The course exposes the student to the basics of ethics, morality, theology and philosophy and their inter-relatedness in healthcare, technology and research involving human subjects. The main objective is to train enough people in the basics of healthcare and research ethics issues so as to do justice to their positions on institutional ethics committees or as members of clinical research teams. In 2011, the Centre signed a memorandum of understanding with the Department of History, Philosophy and Ethics in Medicine at the Johannes Gutenberg Medical University, Mainz, Germany, and another with the Duquesne University, Pittsburgh, USA. These collaborations promote staff and student exchange and take up joint research ventures in the field of trans-cultural clinical ethics. The six-month certificate course in clinical ethics consultation conducted by our centre utilises the services of the faculty members of both these universities. Two one-week long intensive contact programmes in each trimester are supplemented with online assignments and group discussions. This is designed to train participants in the basics of ethics, its applications in healthcare and how to conduct a clinical ethics consultation. The objective is to bring into India the concept of clinical ethics consultation that will have an impact on the ethics of healthcare practices in our country. Vina Vaswani, Director, Centre for Ethics, Professor and Head, Department of Forensic Medicine and Toxicology, Yenepoya University, Deralakatte, Mangalore 575 018 Karnataka INDIA email: bioethics@yenepoya.edu.in

Through a nurses eyes

I sincerely appreciate the editorial Life and Death after Aruna Shanbaug written by Dr Roop Gursahani in the Indian Journal of Medical Ethics (IJME) dated April-Jun 2011. The editorial is very well written and articulated and the author has very aptly discussed every part of the judgment delivered by Justices Markandey Katju and Gyan Sudha Misra of the Supreme Court of India. I would like to add that had the euthanasia plea been granted it would have led not only to intense resentment among all the doctors and nurses of KEM hospital, but would have opened a new avenue for unscrupulous people in our society, who for the sake of property and money, could go to the extent of getting their parents and relatives killed by bribing and conspiring with unethical, and greedy doctors. Hence, there are strong chances of euthanasia being prone to misuse. Moreover, there may be a cure in future for a medical state perceived as incurable today. I strongly oppose the plea by Ms.Pinki Virani. One must understand that in all these years, the nurses caring for her have not tired, but in fact, feel greatly privileged to care for her. Why, then, should the views of a third party, who has not even cared her for a single day, be considered? .Hence, there is no point in worrying unnecessarily about Aruna, writing a book on her life story, or even paying visits to her, as all these things cannot be a substitute for the high quality, holistic nursing care being rendered to her by our fellow nurses working ceaselessly day and night. I must agree with Dr Sanjay Oak, Dean, KEM Hospital, when he said , in his testimony, I must put on record that in the world history of medicine there would not be another single case where such a person is cared and nurtured in bed for 33 long years and has not developed a single bed sore. This speaks volumes of the excellence of nursing care that KEM nursing staff has given to her (1). Once again I salute the spirit of all the nurses of KEM Hospital, Mumbai.
reference 1. Ibnlive.com. Full text: Supreme Courts judgment on Aruna Shanbaug euthanasia petition. IBN Live [Internet].2011 May 18[cited 2011 Dec 13]. Available from: http://ibnlive.in.com/news/full-text-supremecourts-judgment-on-aruna-ramachandra-euthanasia-petition/14520153.html

Radha Saini, Head, Dept. of Community Health Nursing, Rayat and Bahra College of Nursing, Sahauran village, Mohali, Punjab 140 104 INDIA e-mail: radha_s26@yahoo.co.in

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CliniCal trials watCH

This issue of the Clinical Trials Watch provides data exclusively on trials that were registered in the Clinical Trials Registry of India (CTRI) during the year 2010. The factsheet was prepared with a manually created database using data retrieved from the CTRI website. However, as cautioned in the previous issue of Clinical Trials Watch, the data is subject to the dynamic nature of the CTRI website, which allows users to add, edit and remove records. The data was collected from October to November, 2011, using search functions available in the CTRI website and identifying the trials that were registered in CTRI during 2010. A new development in this issues factsheet is the introduction of classification of cities in which the trials are being conducted. The classification scheme used here is a modified version of the system developed by the Government of India (Ministry of Finance) for the classification of cities/towns on the basis of 2001 Census (No.2(21)/E.II.(B)/2004). In the modified classification scheme used for this factsheet, we have only used one criterion- the House rent allowance parameter, to classify the cities. Also, we have considered the Class A and A-1 cities as Class A which include metros and highly urbanised cities and Class B-1 and B-2 cities as Class B which include medium sized cities and the Class C cities as Class C which include smaller towns. Others which are not listed are counted as Unknown. Among the 670 trials registered in CTRI in 2010, 88% of the trials were sponsored by private organizations, most of them being pharmaceutical companies (Table 1). This is indicative of the dominance of pharmaceutical companies on the clinical trials scene in India. Phase III trials occupied the highest percentage (56%) of total trial settings registered in 2010. Among these trial settings, 67% were set in Class A cities (Table 2). These cities are highly urbanised and include all the metro cities in India. Among these trial settings, a substantial proportion (94%) was privately funded trials (Table 3). The data suggests a general trend of large number of trial

settings in highly urbanized cities as compared to other cities in India. This may be due to the infrastructural facilities, higher patient population or ease of access to healthcare facilities that these cities are endowed with. This makes it preferable to conduct trials in these Class A cities as compared to other areas. Other independent research conducted at the CSER indicates a migration of trial settings from Class A to Class B and Class C cities. Table 1. Trial status v/s Sponsor type
Trial status Not yet recruiting Not applicable Completed Suspended Open to recruitment Other/terminated Total Private 52 62 195 8 203 11 531 Sponsor type Non-profit Public Unknown 4 18 8 0 0 0 8 20 20 0 0 0 6 46 9 0 0 0 18 84 37

Table 2. City type v/s Trial Phase

City type Class A Class B Class C Unknown/other Total Phase I 62 12 6 8 88 Trial Phase Phase II Phase III Phase IV N/A 371 1645 641 162 68 437 167 36 27 118 28 12 52 251 219 44 518 2451 1055 254

Table 3. Sponsor type v/s City type

Sponsor type Class A Non-profit Private Public Unknown Total 32 2688 116 30 2866 City type Class B Class C Unknown 12 577 19 2 610 14 277 7 3 301 1 559 19 10 589

Compiled by: Vivian David Jacob, Deapica Ravindran, kinjal Ved, Centre for Studies in Ethics and Rights, Mumbai

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