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ABSTRACT The controversies in Bristol, Alder Hey and elsewhere in the UK surrounding the removal and retention of human tissue and organs have led to extensive law reform in all three UK legal systems. This paper reports a short study of the reactions of a range of health professionals to these changes. Three main areas of ethical concern were noted: the balancing of individual rights and social benefit; the efficacy of the new procedures for consent; and the helpfulness for professional practice of the new legislation and regulation. Recognition of these concerns may help in forging a new partnership between professionals and patients and their families.
The controversies that followed exposure of the retention and use of postmortem organs and tissue in Bristol,1 Alder Hey2 and Scotland3 led to a major revision of laws and regulation of all human tissue. Revelation of past practice, widely agreed to have been unacceptable, coupled with the requirements of the European Tissue Directive, have led to law reform in both Scotland and the rest of the UK. In England, Wales and Northern Ireland, law reform came in the shape of the Human Tissue Act 2004, although many of the finer details of the final shape of regulation have been left to the newly appointed Human Tissue Authority.4 However, one thing is clear from the 2004 Act. The source of power to retain, use and hold human tissue and organs resides in the consent either of the person himself or herself or otherwise of those who are qualified by an appropriate relationship with the deceased. In Scotland, the Human Tissue (Scotland) Act 2006 came into force on 1 September 2006, virtually simultaneously with its English equivalent. There are some differences between the two pieces of legislationperhaps most significantly that the Scottish Act prefers the concept of authorisation to that of consentbut each legislative provision firmly espouses the need for agreement to be reached before tissue and/or organs are removed, retained or used. Although law reform has now taken place in England, as we have said, the new authority with responsibility for overseeing the uses of human tissue and organs is statutorily required to produce codes of practice. Some have already been formulated,5 but this will be an iterative process, meaning that there remains a real opportunity for the voice of professionals to be listened to as detailed policy is developed. To date, professional involvement has been primarily at the institutional level. The voices of the practitioners on the groundpathologists, medical educators and scientists, transplant
surgeons, transplant coordinators and intensive care specialistshave been unevenly heard and often only in a defensive tone. Until now, many practitioners may have felt they were driven by the process rather than being directly engaged with it. Given the publicity afforded to past practices and the depth and strength of the feeling these practices generated, a defensive response from the professional bodies may have been understandable, but as time and law move on, there is now a real opportunity for professionals to participate actively and positively in shaping new law and practice, making them work for everyone concerned. In the light of these concerns, we carried out a small research project, over a period of 9 months, funded by the Biomedical Ethics Funding Committee of the Wellcome Trust, with the aim of examining professional narratives on the ethical, legal and practical aspects of professional practice involving the use of human organs and tissue.i The study was qualitative in nature and involved semistructured interviews designed to explore the following issues in relation to the use of human organs and tissue: current issues facing professionals; changes they had experienced in professional practice; and the predicted impact of the new legislation. Each member of the research team submitted a list of questions that focused on the above issues. These questions were discussed, developed and revised into open-ended questions. The discussion was informed by a multidisciplinary literature review. The research was carried out in two centres: Bristol and Glasgow. Given that this study was intended to examine the views of a range of professionals involved in the different uses of human tissue and organs, a random sample was deemed inappropriate. Respondents were purposively sampled: each had specific insight into different aspects of work with human tissue and organs. Interviews were conducted with 31 professionals: pathologists (n = 13); members of transplant teams (n = 13); anatomists (n = 2); researchers (n = 4). All interviews were recorded and transcribed. The analysis of interview data used thematic analysis tools associated with the grounded-theory approach to qualitative analysis. Preliminary codes were developed from two independent reviews of all the transcripts, after which the initial codes were peer-reviewed and revised to develop a consistent coding frame. The coding frame was used to examine all transcripts to identify emerging themes or hypotheses pertaining
A full report of this project is available from the corresponding author. J Med Ethics 2008;34:104108. doi:10.1136/jme.2006.018358
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The organ retention controversy and the subsequent move to legislation need not be entirely negative in effect, according to these professionals, provided it leads to a fuller debate about the competing values inherent in the controversy. One pathologist hoped for a very different future, one in which pathology practice is out in the open:
Medical science is going to be put back unless we move into a culture where we are all much more open about what it is were doing, where people are much more willing to speak to each other about what we are doing and much more willing to share out ideas. Personally I think it would be a wonderful thing, but I think we are some way off.
The need for transparency was echoed by a researcher, experienced in gaining consent for the use of surgical tissue:
patients are really happy that youve askedwhether or not its just going to be discarded theyre really happy that youve asked them and told them about it. The transparency is what they like. And I think personally that was what was lost with Alder Hey and Bristol.
DILEMMAS OF CONSENT
Another respondent described the sense of fear and uncertainty that now surrounds postmortem pathology practice:
I think you are intrinsically afraid of doing something which is against what the public perceive as normal practice because we know how people were hounded before.
In this atmosphere, some respondents saw a drop in the standard of autopsy practice, with much less done than was the case before all of the controversy:
In autopsy Im very reluctant to obtain any organs, despite, even if, the patients relatives have ticked the box organs may be retained I tend not to bother Even taking histology now is a problem. And some of the forms and the way theyre filled in are ambiguous, so I err on the side of caution and dont take anything. Which might be to the detriment of the eventual diagnosis. And were very wary or I am personally.
As we noted above, the experiences of respondents from the transplant community and from anatomy were very different from those of the pathologists and tissue researchers. Although there were fears that the retained organs controversy would have an adverse effect on donations of organs for transplant and cadavers for anatomical teaching and research, there is no evidence that this happened to any serious extent. Moreover, both groups were already accustomed to working within a framework of legislation (the Human Tissue Act 1961 and the Anatomy Act 1984) and the proposed new legislation was seen as a clarification or endorsement of current practice. However, for these groups the issue of consent (itself a cornerstone of the new legislation) was seen as crucial, and potentially a source of continuing dilemma. For the transplant community, the change from lack of objection in the 1961 Act to a clear set of guidelines based on consent or authorisation was seen as clearly an improvement. Here is how a tissue coordinator described the problems in the old legislation:
The fact that families and staff think that you are going to get consent for somebody to donate their tissue where in fact its legally worded that you are obtaining their lack of objection; the staff and family will fill in the form thinking it is a consent form and thus will circle yes to corneas, meaning that they want to give the corneas, but actually it is seeking lack of objection. So if they put yes they are objecting to donation.
These respondents are not questioning the need for a clearer legislative regime than that of the past, but they do see a real danger that the balance of public goodsprotection of the individual right to consent versus promotion of good medical practicehas gone awry. As one pathologist put it, reflecting on changing attitudes to autopsy:
My own viewpoint is that I do my job for the benefit of society and that autopsy is a form of altruism. Well, I know that half the people in the street would not hold thatthey would hold the ethical position that the body belongs to the parents and the parents have an absolute right to decide what is done with it because its a private issue. I dont think autopsy is a private issue, I think its too important, I think its very much a public issue And the other thing is that we are all members of society and as a group we need to decide what stance we are going to take, are we going to be
J Med Ethics 2008;34:104108. doi:10.1136/jme.2006.018358
In the case of donation of cadavers, the anatomists had to deal with the distinction in the existing legislation between consent for teaching and consent for research, each covered by a different act:
The forms that are sent outbecause the legislation is entirely separate, obviously, for the Anatomy Act and the Tissue Actat the moment basically we send out a lot of
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For other respondents, the difficulties were the familiar ones of the problem of obtaining fully informed consent, especially in distressing circumstances:
many of our patients are undergoing surgery for cancer. And theyre obviously in a very anxious state, and their life has just been given news that really has turned their lives upside down we dont add to that distress, that we also give them, we also adhere to the principles of informed consent, no coercion, we do provide information and, but are also able to consider the fact that some patients do not want any more information, and yet theyre happy to donate.
This respondent saw a positive moral gain in new legislation, which gave full scope to the spirit of the donation as a gift to be used to greatest effect:
I would have thought from an ethical point of view it would be better to make best use of this bequest so if they bequeath their body for research and you could use it for teaching as well then that is making the best use of the wonderful gift that they have given us, so I think that would be a wonderful improvement if it were to be.
In the case of cadaveric donation, there was concern about the way in which grief would make it difficult for relatives to give consent:
the relative at the time of trying to make the decision is not really in a state to talk about these things because of the grief that the person is suffering and this is an issue that no one is kind of interested in looking at.
Consent, then, is seen as pivotal to best practice by these respondents, and this was echoed by the other professional groups.ii All sought improvements in the current practice of, and attitudes to, consent. For one consultant anaesthetist, the emphasis on consent underlined the need for partnership between patients and professionals when tissue from the living was needed for researchconsent, he claimed, had to cut both ways:
I think because consent is so fundamental to this and consent is a two-way process and Im quite happy to have a duty to inform, to educate, to have the information, to collect data, to be honest, but we also have the other side the public has a duty to engage in the other side of it, to read the information one gives, to be prepared to participate, its a two-way thing.
In another response, from a pathologist, the heavy emotional loading in paediatric autopsyfor parents, but also for the pathologistis graphically portrayed:
You know if youve lived with somebody for 40 years as a husband or wife, the body its an old thing But if youve got a child for two days or something like that, and thereve been a lot of people poking needles in them and then suddenly he wants to chop them up, phew, you know so even to have an informed idea of an autopsy would be just horrendous. Ive done some paediatric autopsy and you know the thing is if you see an old person lying on a slab they look as if they belong there. If theres a kid lying in a babygrow, with a teddy bear, they dont look as if they belong on the slab. And you have to take the teddy bear out of their arms, and their baby-grow off, and take off their nappy. And so doing that autopsy is hellish.
This positive endorsement of the principle of consent, however, did not mean that respondents saw it as problem free. For one pathologist, the new insistence on consent was seen as unduly restrictive, in relation to the use of tissue from the living:
Well, I think there ought to have been greater freedom with regards to the examination of tissues as long as its done for the, for good reason, that is to say for diagnosis, teaching, research quality and all the rest of it. That hasnt been the case. Its been very much against all that, with informed consent all the way for all sorts of things and I think thats going to make it very difficult.
Another pathologist echoed these concerns as they relate to surgical tissue, seeing the requirement for consent as too wideranging:
Its the detail of the consent thats being asked [which we are concerned about] not who is being asked or who has the authority to say so, which is one of the main things that has changed in the Act ... And I dont think from my point of view that its a matter of who can and cant give consent. I think its just hardened up in a way thats not considered all the other things that tissues and organs are necessary for.
These comments were made while the Human Tissue Bill was still being debated. In fact the Act does permit this range of activities without consent on tissue from the living, provided (in the case of research) the tissue is anonymised and the research is approved by a research ethics committee. In Scotland, the new legislation will cover only tissue from the deceased. 106
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We should note that considerations of this kind were one reason why the proposals of the Scottish inquiry were to adopt the concept of authorisation rather than consent. Although there were other reasons, evidence taken by the Independent Review Group from some families suggested that, although objectively they would be willing to allow organs/tissue from a deceased person to be used for accepted purposes, they would not wish to receive information about what this entailed. On the other hand, another respondent, a research nurse skilled in gaining consent from patients, expressed the concern that the consent or authorisation gained had to be genuine and legitimate:
My main concern is that the consent is informed, that the authorisation were using is legitimate and theres been no coercion and the patient has had time to consider the information, that the information Ive given has been comprehended, and that its not too much for them.
Finally, while consent was seen as important, several respondents deplored the increasing bureaucratisation of the process, through the research ethics committee system:
Well again, my research work, I find it absolutely amazing, that I want to look at 10 cases, that were done 10 years ago.
J Med Ethics 2008;34:104108. doi:10.1136/jme.2006.018358
On the other hand, the criminal sanctions in the new law in England and Wales have created an atmosphere of uncertainty and fear in the minds of some pathologists:
We are shackled at the moment and everyone is fighting shy of putting the wrong side of the line. Weve got more print letters about the consequences, the dire consequences of doing anything that might be deemed as outside the framework of whats currently now acceptable. weve all been threatened with the rule that if we keep anything that we are not allowed to keep we might face a three-year prison term. I mean thats a huge thing. Im a single parent, so the thought that anything I did might lead to me being imprisoned, well who would look after my children day-to-day?
So far as regulation is concerned, the respondents in England were able to discuss the relative advantages and disadvantages of having a new Human Tissue Authority. The Scottish legislation creates no such authority, but does empower the Scottish ministers to seek the assistance of any public authority (in this case the Human Tissue Authority) in exercising a number of their powers. It is therefore expected that on certain issues, harmonisation between Scotland and England is likely. At the time of our study, the Authority was in the process of being set up, and its effects were yet to be felt; the respondents expressed a mixture of hopes and fears about its likely helpfulness or unhelpfulness for professional practice. These uncertainties are summed up in the following comments from a tissue researcher:
In some ways they should fight our corner, they should fight and be like a representative authority. Its one thing to act in a policing role to make sure were actually doing what were told, but thats a very one-way system and it should be a bidirectional system. Actually we should be able to feed up to them and say actually this is just not feasible and they should be able to fight the corner to make sure that the best interests of research and the best interests of, or the good will of, these people who originally donated are actually properly represented.
A tissue coordinator saw benefits for the transplantation service in the clarity of the new law regarding retention of tissue and organs:
Previously there was confusion for some about retained tissue from postmortem and I worried about the possible impact on donation and transplantation, a view shared by many in the field A lot of work was undertaken at the time to give information about the differences. With the new Tissue Act again its clarity.
For researchers, too, the clarification brought by the new legislation was welcome:
It will finally tell us what we should do with all the archive material which we currently have from a previous era which we are sitting on because we are not allowed to touch it or do anything with it at all.
This element of clear direction was also seen as an advantage for future research:
In terms of the material for research, again, I think that will improve, because people will, everybody will know, the surgeons, the physicians, the clinical scientists, or whatever, will know exactly what they can do. And theyll have a
J Med Ethics 2008;34:104108. doi:10.1136/jme.2006.018358
seen as information too stressful for families to cope with and to be given a fully informed choice in all aspects of medical research revealed how central autonomy has become in all aspects of our social life. People are no longer prepared to be the passive recipients of medical beneficence or to have themselves or their families treated merely as the subjects of research. This cultural change is one to which medical practice is rapidly adapting, and inevitably much of this focuses on the nature of consent. The clinical reality of gaining consent, however, especially in distressing situations of serious illness or traumatic bereavement, is far removed from the philosophical ideal of fully informed consent. In the field of tissue retention and use, the law has become unequivocal. But this leaves a major challenge for those who must implement the law, often in difficult circumstances. Once again it is the subtlety of professional practice within the law that will need much more attention in the future, and this will require a higher standard of training in clinical ethics (and possibly law) than currently is available.
A communitarian approach?
From the point of view of ethical theory, the most interesting outcome of our research has been the suggestion from some of the professionals that the use of tissue in the future should become seen as shared community commitment. Although there seems to be consensus across professionals about the potential benefits of law reform in this area, some tensions continue to divide opinion as to the appropriate model for managing human tissue and organs. The strong awareness of these professionals of the undoubted benefit that may be obtained from the use of body parts can lead them to regard their procurement and use as a primary good, and so more important than the needs of individuals or families. Although nobody rejected outright the need for consent or authorisation, there was a noticeable push towards regarding tissues and organs primarily as a valuable resource for the community. An implication of this would be that the current emphasis on individual choice could be inimical to the interests of society. Elaborating the actual content of the various codes of practice will certainly be informed by legal requirements, but if it is to commend itself to individuals, professionals and society at large it will need to be nuanced, recognising the inevitable tensions between individual rights and the common good.
Acknowledgements: We are indebted to all the participants in this research project for their willingness to speak freely and openly about their concerns. This paper is based on a scoping study entitled Ethical and practical concerns regarding changes to human tissue legislation, funded by the Wellcome Trust (Grant no. 076028/B/04/Z). Competing interests: None declared.
REFERENCES
1. Bristol Royal Infirmary Inquiry. The inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary; Interim report: Removal and retention of human material. London: Stationery Office, May 2001. http:// www.bristol-inquiry.org.uk (accessed 10 December 2007). The Royal Liverpool Childrens Inquiry, HC12, London, January 2001. Independent Review Group on Retention of Organs at Post-Mortem. Final report. Edinburgh: Stationery Office, 2001. Human Tissue Act 2004. ss 1315.http://www.opsi.gov.uk/acts/acts2004/ ukpga_20040030_en_1 (accessed 1 December 2007). Human Tissue Authority. http://www.hta.gov.uk (navigate to Guidance, Codes of Practice) (accessed 1 December 2007). Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine, 1967. Campbell AV, Willis M. They stole my babys soul. Med Humanit 2005;31:1014.
2. 3. 4. 5. 6. 7.
Consent/authorisation issues
The controversy over retained organs revealed a major shift in social values, the force of which was perceived only in retrospect, when the outrage of those families kept in the dark about the retention of their relatives organs was made public. Demands not to be shielded from what was paternalistically
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doi: 10.1136/jme.2006.018358
These include:
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