Beruflich Dokumente
Kultur Dokumente
Bioethics, Medical
Ethics and Health Law
Programme and
Book of Abstracts
Royal Continental Congress Centre
Naples, Italy
November 19-21, 2013
Secretariat: ISAS International Seminars, POB 574, Jerusalem 91004, Israel, Tel: +972-2-6520574, seminars@isas.co.il
Table of Contents
Programme at a Glance
2-3
Social Programme
General Information
10
11
Tuesday, November 19
13
Wednesday, November 20
20
Thursday, November 21
31
Poster Presentations
35
Abstracts
Oral Presentations (alphabetical order by author)
Poster Presentations (by day and by presenter)
37
167
Tuesday, November 19
169
Wednesday, November 20
177
Social Programme
Tuesday, November 19 - 19:00 in Hotel Restaurant
Welcome Gala Get-together Dinner with Musical Accompaniment
Wednesday November 20
19:30 Musical Performance in Hall A - Amelia and Francesca
Rondinella preceded with wine and socializing
21:00 Farewell Dinner in Hotel Restaurant
Optional Tours: See conference registration desk
185
inside back cover
Education Department
Argentina: Moty Benyakar
Australia: Irina Pollard, Russell DSouza, Giuliana Fuscaldo
Azerbaijan: Vugar Mammadov
Bulgaria: Sashka Popova
Canada: Joel Lamoure
Israel: Guy Enosh
Italy: Fulvia DeMatteis, Anna Maria Traversa,
Miroslava Vasinova
Nigeria: Yohanna Dangata
Serbia: Zoran Todorovic
USA: Miriam Cotler
Research Department
Albania: Altin Stafa
Argentina: Juan Jorge Michel Farina
Armenia: Susanna Davtyan
Australia: Michael Lupton, Russell DSouza, Giuliana
Fuscaldo, Mirko Garasic
Austria: Gabriele Werner-Felmayer
Belgium: Laurent Ravez
Brazil: Jose Thome
Bulgaria: Sashka Popova
Canada: Joel Lamoure
Czech Republic: Renata Veselska
Georgia: Irma Manjavidze, Eka Sanikidze
Israel: Guy Enosh, Yoram Blachar, Haim Knobler
Italy: Miroslava Vasinova, Paolo Benanti, Nunzia
Cannovo, Rosa Maria, Gaudio, Pasquale Giustiniani,
Alessandra Pentone, Anna Maria Traversa
Japan: Mitsuyasu Kurosu
Macedonia: Mentor Hamiti
Mexico: Ma de Luz Casas-Martinez
Nigeria: Yohanna Dangata
Serbia: Jovan Babic, Dragoslav Marinkovic, Vojin Rakic
South India: Princy Louis Palaty
Switzerland: Lazare Benaroyo
Taiwan: Daniel Fu-Chang Tsai
UK: Rhys Carwyn-Hooper
USA: Terry Bard, Miriam Cotler, Kenneth Goodman
10
General Information
Conference Venue:
Halls A-H
Royal Continental Congress Center
Via Partenope 38-44
Naples, Italy
Tel. 081.7644621
Halls I-K
LOrientale University
Palazzo Du Mesnil
Via Partenope 10/A - 80121
Naples
Tel. 081.6909121
(5 minutes walk from venue - see map on inside back cover)
Hospitality desk:
November 19 and November 20: 09:00-18:30
November 21:
09:00-14:00
Tours:
For further information and questions about
tours, please contact the hospitality desk.
Dine Around:
A list of nearby recommended restaurants will be
provided at the conference.
Bioethics, Medical
Ethics and Health Law
Scientific Programme
Oral Presentations
Poster Presentations
13
Your own personal genome: ethical issues in directto-consumer (DTC) genomics services
Amy Michelle DeBaets, USA
09:00-10:30
CONSULTA WORKSHOP (1)
Hall B
ETHICS AND MEDICINE: ISSUES AND PROBLEMS IN
SOME AWARD AREAS I
Co-Chairs: Paolo Procaccianti, Filiberto Cimino
Current legislation in the field of preimplantation
genetic diagnosis in European Union members
Francesco Paolo Busard, Italy
Which consent in biobank-based research
Gianluca Montanari Vergallo, Italy
The donation of a persons body after death: a question
of ethics and science
Alessandro Bonsignore, Italy
Clinical experimentation on vulnerable subjects: issues
on the evaluation of a study on patients of the Italian
secure hospitals (OPG)
Valeria Marino, Italy
Immigrants! How Italian emergency health workers
perceive the other patients
Paola Antonella Fiore, Italy
Treatment prospects in sex offenders with paraphilic
disorders: pharmacological androgen deprivation
between the need for social defense and the right to
health
Roberta Carrossino, Italy
Hall E
Hall F
Hall G
14
Hall K
ETHICS EDUCATION
Hall I
Co-Chairs: Assya Pascalev, Washirasorn Saengsuwan
Developing ethical understanding and designing a
rubric to measure progress
Marie Catherine Letendre, Italy
The interdisciplinary ethics course at Howard University
Health Sciences Center: a model of ethics education
for in the 21st Century
Assya Pascalev, USA
Training the moral muscle: a competencies based
approach to the teaching and evaluation of
professional ethics
Johannes Renders, The Netherlands
Ethical behavior in temporal perspective: ethical mirage
phenomenon in applied ethics
Daniela Sotirova, Bulgaria
Thai teachers opinions and reflective thinking on
ethics in science from participating in an academic
service project for science teacher development
Washirasorn Saengsuwan, Thailand
OPENING SESSION
Hall A
15
9
12:30-13:30
Optional lunch break and poster session
GENETICS (2)
Co-Chairs: Froldi Rino, Catanesi Roberto
13:30-15:00
Hall D
Hall C
Hall G
16
Tuesday,
November
19, 2013
Scientific
Programme
Migrating modernitys
Ian Chambers, Italy
17
9
Hall F
Hall G
Hall H
Hall E
18
9
Hall B
ETHICS KNOWLEDGE OF
Hall K
HEALTH CARE WORKERS
Co-Chairs: Dilara Mamedaliyeva, Maurizio Carnassale
Current level of knowledge, perception and practice
of medical law and ethics among Nigerian medical
practitioners: deficiencies and remedies - the Nigerian
model
Awawu Grace Nmadu, Nigeria
About nurses knowledge of medical deontology
Dilara Mamedaliyeva, Azerbaijan
The international code of ethics for occupational health
professionals: a guide for the physicians who work for
Italian Workers Compensation Authority
Maurizio Carnassale, Italy
16:30-17:00
Coffee break and poster session
17:00-18:30
Hall A
EUROPEAN SOCIETY FOR
CARDIOVASCULAR SURGERY WORKSHOP
BIOETHICAL ISUES IN CARDIOVASCULAR SURGERY:
NEW TECHNOLOGIES, NEW FRONTIERS, NEW RULES?
Co-Chairs: Domenico Palombo, Oto Oztekin
The need of ethical training for cardiovascular surgeons
Domenico Palombo, Italy
ECMO: limits and indications, a bioethical discussion
Oto Oztekin, Turkey
EVAR for abdominal aortic aneurysm in elderly patients:
bioethical issues
Lazar Davidovic, Serbia
Peripheral arteriopaty and diabetic patients in
endovascular era: is it bioethically worthwhile?
Giancarlo Bracale, Italy
Hall C
Discussion
Election of SIOF President and Assembly
ABORTION
Co-Chairs: Laura Andrissi, Sara Dejevsarov
Hall D
Hall G
BIOETHICS EDUCATION (4)
Co-Chairs: Sashka Popova, Siti Pariani
Hall F
19
9
Hall H
Hall J
Hall K
20
09:00-10:30
Hall A
AOGOI WORKSHOP (1)
ETHICAL DIMENSIONS OF OBSTETRICS & GYNECOLOGY I
Co-Chairs: Vito Trojano, Antonio G. Spagnolo
Hall D
Hall G
21
9
10:30-11:00
Coffee break and poster session
11:00-12:30
Principles of the education in bioethics and ecobioethics in medical schools and to the healths
professionals in hospitals in So Paulo
Jose T. Thom, Brazil
Bioethics education on vulnerable subjects and groups
Zoran Todorovi , Serbia
Emotional intelligence as methodology and didactic
tool in teaching bio-ethics at nursing schools: practical
steps
Daniella Keidar, Israel
A disability bioethics curriculum that encourages
reflection and open discussion among students and
community members
Julie Rogers, USA
Hall K
Hall J
Hall A
22
Hall D
Hall H
23
9
Hall K
The spiritual assistance
Adolfo Russo, Italy
13:30-15:00
NAPLES FEDERICO II UNIVERSITY ETHICS
COMMITTEE WORKSHOP (1)
ORGAN TRANSPLANTATION
Co-Chairs: Enrico Di Salvo, Roberto Catanesi
Hall A
Futile trials: ethical issues
Massimo Niola, Italy
Hall D
Hall B
24
Hall I
Hall G
Hall J
Hall H
Hall A
25
9
Hall B
Hall D
Hall E
26
Hall G
MULTICULTURALISM (1)
Hall K
Co-Chairs: Aline Albuquerque, Maria Teresa Tassinari
Hall H
Hall B
27
9
Hall D
Hall F
28
Hall G
Hall H
Hall J
29
9
Hall E
Hall G
30
Hall H
Hall K
10:30-11:00
Coffee break and poster session
11:00-12:30
FNOMCeO /NATIONAL FEDERATION OF
Hall A
ORDERS OF PHYSICIENS & DENTISTS/WORKSHOP (1)
MEDICAL DEONTOLOGY
Co-Chairs: Antonio D'Avanzo, Angelo Fiori
Ethics, bioethics and medical deontology
Aldo Pagni, Italy
vegetative state
Marina Manera, Italy
Responsibility construction
Ines Giorgi, Italy
31
9
Hall D
Hall I
32
Hall C
12:30-14:00
FNOMCeO /NATIONAL FEDERATION OF
Hall A
ORDERS OF PHYSICIANS & DENTISTS/WORKSHOP (2)
BALANCE BETWEEN DEONTOLOGY AND LEGISLATION
Co-Chairs: Bruno Zuccarelli, Gian Aristide Norelli
Informed consent and advance directives for treatment
Roberto Longhin, Italy
Hall D
FORENSIC MEDICINE
Hall G
Co-Chairs: Olufumilayo Yetunde Elegba, Andrea Baloghov
Development of molecular pathology infrastructure
in Nigeria: The emerging opportunities, legal and
ethical implications
Olufumilayo Yetunde Elegba, Nigeria
Ethical and legal problems in forensic medicine in Slovakia
Andrea Baloghov, Slovakia
WAR, SECURITY AND ETHICS
Co-Chairs: Mohd Zin Bidin, Barry Roth
Hall H
Hall I
Hall E
33
Hall F
Hall J
34
Poster Presentations
Tuesday, November 19, 2013
T01
Acquisition of consent to medical treatment under
mandatory health: simple binding legal or the main
instrument for the promotion of therapeutic
relationship
Cristiano Barbieri, Italy
T02
Stability over time in the preferences of older persons
for life-sustaining treatment
Ins Maria Barrio Cantalejo, Spain
T03
Assisted reproduction in Italy: bioethical, juridical and
medico-legal dilemmas
Rosagemma Ciliberti, Italy
T04
Prison treatment and ethical dimension
Paolo Danesino, Italy
T05
Moral and legal responsibilities - dilemmas faced
in pharmacy - experiences from the Republic of
Macedonia
Merita Dauti, Republic of Macedonia
T06
Ethical standards and normative regulations in
the field of medical care in emergency situations
Alena Donika, Russia
T07
Linguistic and cultural validation of an instrument for
the analysis of ethical values of nursing students with
special reference to honesty and altruism
Stefano Finotto, Italy
T08
The act ethics in health care: the path of ethics
Raffaela Genzale, Italy
T09
The Interuniversity Research Centre on Bioethics of
Naples - activities on the bioethics of the beginning
life
Pasquale Giustiniani, Italy
T10
Current status of institutional review boards and
approvals of clinical research in oriental medical
hospitals in Korea: a survey
Jung Hee-Jung, South Korea
T11
Attitude, practice of clinical physicians in Vietnam
on medical errors and conflict of interest
Tran Thi Thanh Huong, Vietnam
T12
Preventive mastectomy: overtreatment or personal
harm?
Francesco Introna, Italy
T13
The cloning and its ethical-legal implications
Fatbardha Ismaili, Republic of Macedonia
35
T14
Dealing with violence in a combined organizational
structure - an instructive response from a therapeutic,
ethical and safety perspective
Ronit Kigli, Israel
T15
Health care guarantee in secondary health care telemedicine to the rescue
Hanna Kuusisto, Finland
T16
Missing person DNA data-base to counteract the illegal
traffic of organs
Massimo Lancia, Italy
T17
The foundations of the Italian medical ethics following
the finding of the Professional Codes of the Medical
Chamber of Istria (1897) and of the Medical Chamber
of Trento (1900)
Sara Patuzzo, Italy
T18
Emotional communication in helping relationships for
the treatment of disorders related to new forms of
addiction
Rocco Quagliariello, Italy
T19
A pilot study of pharmacy students perceptions
regarding ethical values, conscientious and religious
objections
Vojin Rakic, Serbia
T20
National growths characteristics of bioethics in Russia
Natalia Sedova, Russia
T21
Ethics, hemodialysis and patients with differing ages
Ronen Segev, Israel
T22
Professional dignity in nursing implicates patient safety
for Italian nurses
Alessandro Stievano, Italy
T23
The experience of ethics committees in the
Andalusian System of Public Health, Spain
Maribel Tamayo Velzquez, Spain
T24
Bioethics contribution to integral formation on higher
education
Valeria Trigueiro Santos Adinolfi, Brazil
36
Poster Presentations
Wednesday, November 20, 2013
W01
Ethical problems of integration of children with
disabilities in Bulgaria
Silviya Aleksandrova-Yankulovska, Bulgaria
W15
Post mortem fecundation rules in EU Members:
the usage of sperm after donors death
Paola Mancarella, Italy
W02
The Health Technology Assessment (HTA): the
distinction between innovation and new business
Rosalba Caldarazzo, Italy
W16
Archives of surgical pathology as a tool for
comprehension of biological behaviour of malignancies
Gabriele Margiotta, Italy
W03
Regional differences within the programmes of
screening for breast cancer: ethical problems of health
policy and management
Michelle Capasso, Italy
W17
Sensitization and incorporation of ethical practices in
pathology postgraduate curriculum in India
Mary Mathew, India
W04
Compassionate use: Italian case law
Irene Catarinozzi, Italy
W18
Impact of eastern socio cultural determinants on end
of life decision making
Princy Louis Palaty, India
W05
Accidental thawing of embryos and oocytes:
legal aspects and medico-legal profiles
Michela Cicconi, Italy
W19
Cultural and ethical issues on female genital mutilation:
the Italian situation
Laura Panata, Italy
W06
Ethics committees and GCP and GLP Rules
Susanna Davtyan, Republic of Armenia
W20
Bioethical aspects of pharmacotherapy of rare diseases
in Serbia: from the point of view of medical students
Milica Prostran, Serbia
W07
Socio-economic factors related to the withdrawal of
chloroquine (CQ) in the range of production plant
Malian pharmaceuticals
Samba Diop, Mali
W08
The future role of the invasive autopsy in the
investigation of deaths and possible alternatives
Italian Group of Young Medico-legal doctors
W09
The determination of death with regard to organ
transplantation: 20 min vs 2 min
Arianna Giovannetti, Italy
W10
Reasons for asylum seeking and medical certification
Luciano Gualdieri, Italy
W11
The European legal framework for Compassionate
Use Programmes: similarities and differences between
five member states to guarantee a better quality of
life in patients affected of seriously and/or chronic
debilitating or life-threatening diseases
Sara Hemied, Italy
W12
The use of unapproved drugs for compassionate use:
Italian law and re-emerging regulatory requirements
Laura Iovenitti, Italy
W13
Styles of bioethics education in Poland
Pawe ukw, Poland
W14
Nurses coping with ethical dilemmas during work
Helen Malka-Zeevi, Israel
W21
The ethics of treating adolescents with anorexia
nervosa: the case for justified paternalism
Tomas J. Silber, USA
W22
The strategic plan on bioethics of the Regional Ministry
of Health and Welfare of Andalusia (Spain): an
innovative experience in public policy
Pablo Simn-Lorda, Spain
W23
Should or must there be a finding of materiality
regarding, and disclosure of, physician financial conflicts
of interest that both patients want to know about
and that, when disclosed, affect their decisions whether
to accept care recommendations?
Roy G. Spece, USA
W24
Attitudes, perception and knowledge of bioethics
among physicians and post graduate trainees of
hospitals of Islamabad and adjacent regions
Rizwan Taj, Pakistan
Bioethics, Medical
Ethics and Health Law
Abstracts
Oral Presentations
(alphabetical order by author)
CONSCIENTIOUS OBJECTION
Franco Alberton, FNOMCeO Deontological Committee, Italy
deontologia@fnomceo.it
The term conscientious objection indicates a generic refusal to perform
actions which, even if imposed by law, are judged to be irreconcilable
with ethical, religious or ideological principals. Refusing treatment
assumes enormous relevance in the medical field, given the primary
interests of the individual and also the potential consequences for the
conscientious objectors of possible infringement of the law (omission).
There is, therefore, a difference between the objection contemplated and
allowed by the law as an exception to the obligation imposed and the
objection which, if implemented, constitutes an effective breach of the
law.
In Italy, conscientious objection as a right contemplated by law is
envisaged, in the health care context, in only three cases: in the
regulations on voluntary interruption of pregnancy, in medically assisted
procreation and in those regarding experimentation on animals.
Above all, in the first two cases the possible conflict with principles
deemed to be non-renounceable for a large number of citizens and,
therefore, also for many health operators, appears evident.
We can talk about illegal objection when the refusal involves actions
required by law without exceptions. In such cases, the person who raises
the conscientious objection and refuses the treatment may incur legal
consequences, while on a deontological level the problem may turn out to
be very complex. For the health operator, in fact, the possibility of
abstaining from activities which are in stark contrast with his/her
principles, is recognized. This right must, however, always find a just
equilibrium with the interests of the person who is requesting help.
39
40
L. Andrissi , G. Mottini
1
Tor Vergata University, Italy
2
Campus Bio-Medico University, Italy
l.andrissi@unicampus.it, g.mottini@unicampus.it
Several studies have showed a high rate of Induced Early Abortion (IEA)
among irregular immigrants and refugees (up to 50% of pregnancies)
especially for those coming from Sub-Saharian Africa.
100 women (aged 27 in mean, 43 IEA), temporary living in the two largest
Reception Centres for Asylum Seekers (CARA) in Europe (Crotone and
Mineo, Italy), were asked to fill a questionnaire for epidemiologic aspects,
and semi-structured interviews were performed to identify the
anthropologic and ethic triggers that push to IEA and find solutions. The
main languages were English and French.
Statistical analysis shows that to come from urban settings, to be single,
Nigerian, with a low educational level and a poor knowledge on
reproductive cycle and family planning methods (natural, chemical,
chirurgic), was related to IEA (p<0,05). The most influential factors driving
to IEA were economic and cultural (fear of parents, ashamed to be
misjudged). Cultural, ritual and religious beliefs (foetus identity, when he
became a living human being inside the womb) can be both, push and pull
factors. The lack of their enlarged family, migration experience, fear of
the future have an important influence for the choice. Interviews report
interesting aspects of narrative based medicine and show how loneliness
and fear are the root causes that drive to IEA. To strengthen women
personality, create educational and moral certainties and supporting
networks, aimed at irregular immigrants, inside and outside the CARA, to
find mothers, grandmothers and aunts substitutes, it may be the right key
to help them.
41
42
1,2
43
44
45
46
DECLARATION OF HELSINKI
Jeff Blackmer, Primary Ethics Advisor, World Medical Association;
Office of Ethics, Professionalism and International Affairs,
Canadian Medical Association, Canada
Jeff.Blackmer@cma.ca
Background: The Declaration of Helsinki (DoH) is generally considered to
be the pre-eminent guiding document in research ethics for physicians
participating in research studies, and for many Research Ethics
Committees around the world. First published in 1964, it has been
updated several times, most recently in 2008. By the time the UNESCO
meeting takes place, the WMA hopes to have completed another revision
47
As concerns the evaluation on criteria and the trials discipline, there are
Countries where clinical trials are submitted to only one law whereas in
others, like Italy, each aspect of scientific research is regulated by specific
norms.
In many European Countries like Turkey, a centralized procedure is
followed at national levels according to which it is the Ministry of Health
that express its judgment on the protocol under examination.
In other Countries research projects are evaluated at local (peripheral)
level.
In particular, at local level two typologies exist:
Regional or at district level (Belgium, Czech Republic, Finland, Latvia,
Lithuania, Netherlands, Norway, Slovenia, Sweden and Switzerland, and
the really local level of universities/hospitals (Italy, Bulgary, Estonia,
Germany, Ireland, Poland, Serbia, the United Kingdom, and Spain).
Almost all EU and ERA (European Research Area) countries have a
National Ethical Committee with leading functions for the other European
Countries, sometimes without any active role in the evaluation of the
trials, some other times acting as appeal evaluators of study projects
rejected at local level (Bulgaria, Cyprus, Denmark, Finland, France, Ireland,
Latvia, Lithuania, the Netherlands, Poland, Portugal, Switzerland, Sweden
and the United Kingdom).
In European Countries Ethical Committees, the layperson i.e. a member
who does not belong to the world of science and biology is present to
different extents, such as in Denmark where more than half of
Committees members are laypersons.
Another peculiar aspect is the number of local Committees.
Directive 2001/20EC following its principle of assigning trials to high
quality centers has eventually reduced the number of Committees in
Europe.
In Italy, Act 189/2012 dramatically reduced their number subject to the
population size (1/1.000.000) which involved a series of predictable
negative effects that will be analyzed in another paper.
48
The Italian legislation for WDT has been introduced by Unified Conference
no. 99/2007 and Law no. 81/2008 as improvement in safety, productivity
in the worksite and public health. The legislation calls for mandatory
procedures for screening tests (I Level) on biological samples for at-risk
workers, performed by occupational health specialists, and for
confirmatory tests by GC/MS or LC/MS/MS (II Level), performed by
forensic laboratories.
Therefore, the application of WDT implies some basic ethical principles,
that occupational health physicians and toxicologists need to employ, in
order to avoid the violation of the workers rights and to prevent disputes
about professional responsibility. These include, but are not limited to:
Right to Privacy and data protection: this is very important, since
WDT involves collecting sensitive data, both on use of drugs and about
medications taken which might influence the test result;
Informed consent: the employee has to know, ideally prior to taking
the job, that abstinence is an expectation, and that WDT is planned;
Quality assurance in Sample collection and screening/confirmation
testing: several critical factors can affect results, and lead to
administrative law disputes about use/non-use of illegal drugs. These
factors are numerous and consist primarily in specimen collection
procedures, chain of custody, contamination or adulteration of
samples, number of tested drugs and detection ranges, cut-off and
reliability of screening tests with regard to the differences in target
antigens. Therefore, it is necessary that WDT is conducted with
respect of analytical, legal and ethic issue in order to prevent damages
to workers through false positive results;
Provision of addiction counseling: this may include treatment and/or
rehabilitation in positive drug test cases, distinguishing between use
or abuse, with or without dependence;
Support in transitioning to more suitable employment if appropriate.
In this paper, some real cases are discussed, in order to highlight the
many ethical dilemmas posed by the management of alcohol and drug
problems in the workplace. These dilemmas involve a careful balancing
between the respect to involved individuals, and the obligation to
correctly manage the financial resources and to safeguard the safety of
other workers, especially when WDT involves the collecting of sensitive
data (such as the use of illegal drugs, or the assumption of medications).
In conclusion, WDT can have an important role in safety on workplace,
especially in the occupations where the employer and public is entitled to
expect the highest standards of safety and probity. Aside from this, there
is no justification for drug testing as a way of policing the private
behaviour of the workforce, nor is it an appropriate tool for dealing with
most performance issues. Even where drug testing does have a role it
should be approached with caution, and implemented in an ethical, fair,
transparent and inclusive way.
49
Ethical Use of Social Media, this white paper explores the existing
literature, focusing among others on the legal and ethical aspects of social
media use in medicine.
Results: Social media use by physicians raises various legal and ethical
implications. Posting of inappropriate, abusive, personal, malicious or offtopic material may lead to legal sanctions and threaten the credibility of
the medical profession. Disclosure of information causing disturbance or
substantial interference with the provision of health care and the
permanence of digital content transmitted online may also have legal
implications. Health-care gaps in social media access among patients of
lower socioeconomic status, pose further ethical considerations. Specific
forms of pathology, for example status anxiety and other maladaptive
behaviours have also been described in this new field. Secondary data
usage from social media for research or public health purposes raises a
number of issues pertaining to patient privacy and confidentiality.
Conclusion: It is apparent that many of the legal and ethical
considerations in the use of social media are already reflected in the
standards and codes set out by physicians, institutions and regulatory
bodies alike. It is therefore important for policymakers and stakeholders
involved to work together to address and develop standards for
optimising social media usage and mitigating potential risk. There is a
tremendous potential in harnessing social media for health care, but
equally large potential pitfalls must be considered.
50
51
submitted. Other times (6% of cases) the Promoters were formally invited
to adopt adequate insurance coverage.
Multiple insurance inadequacies were found in several research
protocols. Seven out of the 191 protocols, which modifications had been
requested for, were rejected for failure to comply with the requests for
changes made in relation to inadequate insurance coverage.
The results of our study reinforce our belief that damage compensation
guaranteed to people participating in a clinical trial, by means of a
suitable insurance policy, is an essential protection tool for an appropriate
balance between ethical values, clinical risks and economic interests.
52
53
informed con sent remains one of the most contested issues of biobank
policy, other ethical challenges also still require careful attention: these
include the protection of vulnerable subjects, the safeguarding of privacy,
the communication to donors of research results, conflicts over patenting,
access, and the need for open science, and the rights of donors to retain a
property claim or control over their tissues. Furthermore the ethics
consultant may be involved in a campaign of ethical education to ensure
that all researchers involved in biobanks are aware of their ethical
responsibilities, and donors are better equipped with an ethical
understanding of donation significance.
54
same, which considers and describes both the context in which intuition
arise, as well as its content or intentioned object. We exemplify this
new approach supporting the need to go beyond two extremes. On the
one hand, the anarchical conception of intuition, that is to say, the idea
that it is not possible to establish the conditions that favour its
emergence, on the other hand, the economization of intuition which
refers to its translation into a merely quantitative dimension.
55
56
57
58
The paper builds on the analysis of the profiles of the legal significance of
advance directives for medical treatment in Italy, and aims to highlight
the convergences and divergences between the Italian experience and
that of some other countries, not only in Europe (Spain, UK, Belgium,
Holland, Switzerland, Israel), which governed in a more or less organic and
complete the phenomenon of advance directives. The privileged
perspective of the comparison between different experiences allows you
to identify issues and difficulties that have been faced in all systems
considered, and, for this way, it allows to carry out a study to select and /
or develop possible proposals for solutions for these issues and
difficulties.
The broad list of subjects about which it is expected the discussion is as
follows:
1. Advance directives for medical treatment: problems and prospects in
the Italian experience. 2. Principles and solutions in Europe. - 2. The
experience of some European countries: the document de voluntades
anticipadas in Spain. -3. (continued) The living will in the UK. 4.
(continued) Statements assets and choices of euthanasia in Belgium,
Holland and Switzerland. - 5. The original approach adopted in the State
of Israel. - 6. Issues arising from the comparison between the experiences
examined and possible solutions.
59
60
MIGRATING MODERNITYS
Iain Chambers, University of Naples, Orientale, Italy
Speaker intends to talk of the refashioning of modern society, cultures
and identity in the light of the planetary migrations that have historically
constituted the hubris of the modern world. The principal scope of these
considerations is to render explicit the idea of migration as central to the
historical and cultural processes that continually renovate our being
positioned in planetary perspectives and possibilities. This, in turn,
transforms the question of migration from a marginalised socio-economic
problem into a profound critical challenge, leading to the adoption of
what we might consider to be the multiplicities of a migrating modernity
that is not only ours to define and manage.
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the recipient country. Such programmes are usually only for short
periods. The present paper makes a critical analysis of vertical health
programmes with respect to their challenges, advantages, disadvantages
and ethical implications on Integrated Health Care Delivery Systems in
Africa. We undertook full searches (May 2003 - April, 2013) of original
research, reports and reviews using Medline, PubMed, Embase and World
Health Organisation (WHO) Databases. Search words were advantages,
Africa, disadvantages ethical implications, integrated health care
vertical programmes, vertical programmes and Africa. Findings show
that donor organizations usually offer their interventions with specific
regulations on the receiving countries. The stringent conditions and
procedures set by donors sometimes distort existing integrated
healthcare planning and budgeting of the recipient country. These
findings show that, in spite of huge resources invested in vertical health
programmes in Africa, some of them are still very far from achieving their
set goals and objectives. This results from their strict unilateral approach
in exclusion of horizontal programmes of recipient countries. We suggest
a complementary approach that would allow symbiosis of both vertical
programmes and integrated health care systems thus facilitating each
other to maximize their potential for efficiency and cost effectiveness of
their respective objectives.
Acknowledgements: Kaduna State University, Kaduna, Nigeria and Centre
for Biomedical Ethics and Law, KUL Leuven, Belgium for funding
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for a solution. The ethical problem is that a kid can die because some
unauthorized person performed surgery without the essential sanitary
equipment. Given this emergency status, underlined by those who face
the immigrants problems daily, it seems indeed necessary to make a
further official step to avoid new tragedies, because Africans will in any
case keep performing circumcision. Either they go back to their country of
origin, or they fly to London, where the surgery can be carried out in
public hospitals. However, both solutions are extremely expensive, and
most immigrants cannot afford them. In Italy the circumcision surgery is
free in all cases of therapeutical prescription (for instance in cases of
phimosis). An obliging practitioner might prescribe circumcision even
though a real therapeutical need is not present. My intervention will
analyze the reasons for the health structures, describing the history,
evolution, and the conclusion, finally asking some important ethical
questions.
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information before deciding about the fate of the biological material that
still belongs to them.
This form will be illustrated in the paper as well as the rules for filling it in.
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person) and dignity of the person although pursuing their inherent goal of
acquiring new knowledge.
The Nuremberg Code was a turning point in the protection of the rights of
patients involved in experiments but only in later international ethics
documents the primacy and superiority of the individual over collective
interests in research protocols has been clearly stated.
The need for scientific trials to provide results that are useful for the
whole society is not ignored because otherwise trials on healthy
volunteers, which are of no direct usefulness to them, would not be
permitted.
Yet it has been clarified that the primary goal in scientific trials is to
acquire insights and find therapies useful for single individuals.
However, in our opinion the protection of the well-being and safety of
every single individual involved in a trial cannot be considered nowadays
in absolute terms with respect to the possibility of obtaining useful
knowledge for the whole society. After decades of trials on humans in
compliance with strict rules the authors deem there is new room, with all
due caution and juridical limitations, for solidarity-based derogations
from the individual psychophysical integrity principle in favour of the
society.
Hence, precise criteria are needed to allow for these derogations in
favour of the progress of mankind and in total safety. In this sense,
voluntarily giving up ones own psycho-physical integrity as a contribution
to research is not to be interpreted as a waiver of the constraints
protecting the individual rights of the patient involved in the experiment
but as the acceptance of risks by the patient after thorough assessment of
all time-related, dimensional, anatomical and functional aspects and
provided that all ethical and juridical norms are complied with.
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their clinical practice. The study used the grounded theory method of
Strauss and Corbin with in-depth, semi-structured interviews to
understand the lived experiences of twenty eight (28) participant
physicians whose age ranged from 27-70 years.
After open coding of transcripts of interviews, axial coding and selective
coding of emerged concepts, six distinct yet related categories were
identified namely: a.) the nature of ethical dilemmas, b.) causal conditions
triggering the dilemmas, c.) contextual conditions of the ethical
challenges, d.) intervening conditions affecting the negotiation of the
dilemmas,
e.) action/ strategies in resolving the dilemmas and f.) outcome/
consequence of the decision on these ethical challenges. Several
attributes under each of the six major categories were identified by the
study.
From the results, it can be concluded that the overarching motivation of
physicians in the negotiation of ethical dilemmas is Doing Right for
Patients, the core category that emerged after analysis of data. It is the
category that ties up all the other categories and can explain the six
distinct but related subsidiary categories and their attributes. Several
factors were identified as having an influence in the decision making
process of physicians; one of which is the limited impact of the ethics
courses during their medical education. Therefore, there is need for
development of new models of medical ethics education that is more
attuned to local health problems and issues as well as strategies for
horizontal and vertical integration of ethics teaching with the rest of the
medical curriculum.
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can be derived in a manner that reflects the real health needs of the
indigenous communities. Out of their narratives, this study follows a
Spinozan style of ethical analysis, which puts emphasis on the interrelated
aspects of knowledge system, positioning of laden interests, and the
formation of conative power to achieve the desired health outcomes.
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feasibility of adopting a full disclosure policy and the extent to which such
a policy can help reduce administration and legal costs.
When an error occurs it has a physically, emotionally and economically
traumatizing effect upon the patient. Patients suffer a range of negative
emotions including: sadness, anxiety and depression. In addition, patients
are angered by the fact that the error was predictable and could have
been prevented and they fear that further errors or adverse events might
occur. In any case, documented research shows that the patients and
their families expect those responsible to acknowledge their error and
give a reason for the adverse event. It is well known that iatrogenic
injuries are accompanied by a high degree of tension in the patientodontologists relationship; patients want information about errors which
can occur during treatment; moreover, it is their right to receive such
information. At the same time, the odontologist staff should consider it
their moral and ethical duty to acknowledge errors and discuss them with
the patient and family.
Much more studies have to be carried out to be able to comprehend the
ethical and economic impact of a full error disclosure policy.
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The report aims to fully explore the psychological and ethical aspects of
this important subject.
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Key questions include: How valuable are non-human animal lives (what is
their moral status?)? What constitutes a good justification for taking
animals lives or causing them harm? Do most biomedical experiments
provide a strong enough justification for the use of animals? Should there
be limits on the amount of harm we can cause animals, and, if so, what
should these limits entail? The goal of this presentation is not to advocate
for a specific position, but to lay out the key normative issues and to
foster productive discussion.
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RESPONSIBILITY CONSTRUCTION
Ines Giorgi, C. Sguazzin, Marina Manera, Italy
ines.giorgi@fsm.it
This talk focuses on the integration between responsibility principle and
hope principle according to Blochs perspective. In this theoretical
framework four clinical cases will be analyzed. Patients histories of life
and diseases offer breathing spaces about therapeutic choices and
sharing of responsibility through relations with different health care staff.
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the younger generation must face in order to make conscious and mature
choices.
In this direction, our research group proposes to exceed the terms of the
conciliation, speaking rather of harmonization, both within the intrafamily dynamics and in the relationships between labor (defined as the
area of productive work) and family (understood not only as a
consumers unit, but as a group that produces a social capital).
From a bioethical and biopolitical point of view, all these argumentations
lead to the following consequences:
1. The bio-political governance of future and new families will no longer
apply the logic of contrast between work and family, as if there is an
opposition between the strict world of the market and the more
flexible rhythms required by the familial relationship.
2. The education in the medium and long term will have to invite the
younger generation to a process of mentalization, in which the
following bioethical themes will have an increasing relevance:
a) careful and informed management of human sexuality and fertility,
in a quest for a balance between different possibilities offered by
modern technologies in the field of medically assisted
reproduction (this one, moreover, is a field of new work close to
the family);
b) growth of affective, relational and sexual bonds of couple, who will
have to become more compatibles with times and regulations
still too strict of work environments, organizations and places;
c) relevance of the educational element, and not only in terms of
instruction and formation, in the definition of the essential
features which must have new families, which are small producers
of relational and social capital, giving priority to the themes of
human care, equal gender opportunities, welfare of children and
young people.
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In any case, the clinical condition that lead to the Cesarean section (under
the patient request and /or under the physicians proposal) as well as
those conditions that results in failing to perform it (even through under
election request) should be duly reported on the patients medical record
and documented by various examination i.e. imaging, lab tests and
specialistic consultation.
As conclusion to provide the patient with the correct information is
fundamental not only to obtain her consent concerning therapeutic
options, but most of all, to favor therapeutic choices that do not have any
negative impact both on the pregnant patient and the fetus.
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the health systems that in some cases are edging closer and closer toward
bankruptcy.
In respect to pharmaceutical companies profit and market share have
become the holy grail of both research and marketing. Has ethics been
overridden by commercialism and if so what are the repercussions?
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of the term leads to different ethical, and hence legal and practical
approaches to end-of-life issues. Our particular focus is on: (1)
withdrawing/-holding life-sustaining treatment; (2) respect for patient
preferences; and (3) assistance in dying.
Given the difference in the understanding of dignity, and the underlying
philosophical approaches it feels that there is still a long way to go before
we can establish common guidelines on end-of-life decisions across
Europe and beyond. However clarifying the use of the term dignity in
different discussions around Europe could hopefully facilitate this
endeavour.
Adrian Hoxha , Genci Dervishi , Edjona Bici , Odela Risilia , Ola Hysaj ,
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2
Imelda Kasapi , Klejda Risilia
1
Faculty of Medicine, Albania
2
National Association of Public Health, Albania
adrianhoxha@yahoo.com
Background: The health professionals (HP) by participating in ongoing
education trainings update their knowledge in accordance with the
criteria defined by the NCCE. Ethics and health communication was one of
the training modules.
Aim: Evaluation of training activities of HP in the field of ethics and health
communication.
Methodology: The study was conducted through an anonymous
questionnaire in 8 districts of Albania, in 2010 and 2012 and includes
participants in the ethics and health communication training as general
practitioners, pharmacists, managers and nursing staff. The data were
analyzed with statistical package SPSS 19.
Results: 194 HP participated in the training of ethics and health
communication. 32% of participants was male and 67% female. 30.9% of
the participants took part in 2010 and 69.1% of them in 2012. 46.9% were
general practitioners / family doctors, pharmacists 41.2%, 3.1% managers
and 8.3% nursing staff. 61.9% assessed as very high level the lecturer,
57.7% of them the subject content, 54.6% the audio-visual equipment,
58.2% discussion topics and 45,5% the hall where the training took place.
42.8% assessed the knowledge obtained in this training as very new. In
88.1% the participants stated that their expectations about the training
were fulfilled. The statistical analyzes indicate a moderate positive
correlative relation with 0,01 significance level between age and
assessment of new knowledge in these training activities.
Conclusion: It was noted that attendance doubled in 2012 compared with
2010. Older Professionals assessed the knowledge as new also because
their university curriculum did not include ethics and health
communications.
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share the moral and ethical values and attitudes they are based on, occurs
(for example, euthanasia, authorization of same-sex marriages and
possibilities for such couples to enjoy assisted reproductive technologies
for their procreation, etc.).
Another risk is the legislative fixation of ethical principles acceptable for a
community, but with their formal utilization and emasculation of their
essence. The mandatory forms of informed consent diluting the essence
of the consenting process and the final authorization to research or
treatment is a significant example. This can also be exemplified by the
provisions appearing in legislations of the newly emerged states whereby
the independent ethics committees members are to be appointed by
the order of the health care institutions chief doctors.
At the same time, integration processes give great opportunities that
should be utilized to the fullest possible extent by all countries, especially
by the developing and the newly emerged ones. Implementation of the
best legal practices and solutions capable of resolving the burning issues
is one of such opportunities. In some newly emerged countries, for
example, there exists the issue of the two extracts from the medical
records when the patient suffering from a hard-to-treat disease
dangerous to life and his or her relative who the patients medical
information is disclosed to in full, get two extracts with different medical
data, including diagnosis. This situation can hardly be accepted from the
ethical and legal viewpoint. An important task is therefore the exchange
of experience and implementation of good solutions for such problems.
Cross-fertilization both between bioethics and health law and between
the bioethical models and legal doctrines dominating in different parts of
the world seems to be the main direction for the development.
Within the past three decades scientists (example, Koch, 2005) have
uncovered a wealth of difficult-to-measure habits of mind that lead
people to happy and fulfilled lives. These include persistence, learning
from ones mistakes, responsible risk-taking, controlling ones impulses,
listening and responding with empathy, reading people, situations and
ideas (Costa and Kallick, 2008). These scientists theorize that ones
character is formed within ones unconscious mind. Others, like
psychologist, Timothy Wilson (2002), contend that the unconscious mind
does all of the work. Contrastingly, scholars who study autism put forth
three prevailing theories, which identify the inability of an individual with
autism to recognize or understand others intentions (example: beliefs,
fears, desires or wants) the very elements that were identified as
building blocks to success (Barnbaum, 2008), Given the centrality of the
aforementioned qualities how might educators and their families work to
secure the moral compass of children with autism? The impetus for this
question stems from a service learning work experience that lead the
authors to lead a workshop for parents of children with autism. These
parents sought the knowledge, the expertise and key understandings
about how to direct the inner lives of their children. The authors hope
that the question they pose for discussion would generate ideas for
collaborating to both develop studies and outreach programs aimed at
assisting parents and educators of children with autism in less resourcerich countries where access to well-established therapies and resources
are scarce.
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The objective of the present study is to discuss the reasons and the
solutions for the current need of Judicializing of the Private Health Care in
Brazil. The reasons for the transgressions committed by the Health
Insurance Plans to the detriment of rights and the interests of its insured.
The applicable penalties. What are the roles of the regulatory bodies?
Why does the State fail in promoting regulatory policies in this kind of
activity? The object of this discussion is the presentation of the Brazilian
reality, the solutions imposed by the Brazilian Judiciary Power and how
the companies in this segment act before the concession of judicial orders
in favor of the insured.
The civil and criminal liability of these companies agents and directors as
one of the feasible solutions. How the Brazilian legislation deals with the
issue. What are the legal applicable codes?
This study will allow the students, Law operators and health care
professionals to know, based on the Brazilian law and compared laws, the
difficulties and the solutions adopted by the Brazilian juridical system,
always considering the prevalence of the general principles of the Law,
and above all the principle of dignity of the human person over financial
and political interests.
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Safety", "On drug treatment services" and etc. are among them. The most
important of them is the act adopted in 1997 the Law "On public health
protection of the Azerbaijan Republic."
Bioethical processes implemented today in Azerbaijan are carried out in
close integration with the international. The right to a decent life and to
health care is a basic inalienable right enjoyed by every citizen of the
country. Assigned to the group of the most important social and cultural
rights, health insuring and protection, integrity, dignity and autonomy of
man have been declared in the very first national legal acts, including the
national Constitution.
Following this discussion I will argue that the time has come for courts to
recognize the existence of a new head of damage, namely, interference
with the right to autonomy. According to this approach, when a patient's
right to autonomy is infringed, that patient suffers an injury for which he
is entitled to compensation. This injury is unrelated to the existence of
physical injury or to proof that a different decision would have been made
by the patient upon becoming fully informed.
I will argue that recognition of interference with the right to autonomy as
a new head of damage is commensurate with the idea of patient
autonomy underlying the doctrine of informed consent. I will further
claim that adoption of this rule is consistent with considerations of
deterrence. Finally, I will suggest that recognizing this new head of
damage provides a solution to issues that go beyond the framework of
informed consent, such as claims for wrongful birth or wrongful
pregnancy.
The patients right to autonomy has been protected under law through
the doctrine of informed consent for the past six decades.
From the mid- 1950s physicians have been under a legal and ethical duty
to inform the patient of proposed medical treatment. Ancillary to the
duty of disclosure is the physician's duty to receive the patients free
consent. At the heart of these rules stands the ex-ante recognition of the
patients right to autonomy.
However, apart from extreme cases which fall within the ambit of the tort
of assault, the patients right to autonomy receives protection ex-post
only if two conditions have been met: the patient suffered actual damage
and the patient can prove that had he been fully informed he would not
have consented to the treatment. Thus, protection of the right to
autonomy is subject to proof of actual damage and proof that a different
decision would have been made upon obtaining full information. A
patient whose right to autonomy has been infringed but who has not
suffered actual injury or cannot prove that he would have decided
differently is not entitled to compensation. Respectively, in neither of
these cases are legal sanctions imposed on the physician who infringed
the patient's right to autonomy.
Over the last few years as the number of patients diagnosed with autism
rose sharply, interest and discourse have greatly increased. At the center
of the discourse reside the many ethical questions that arise in autism.
The diagnosis of autism is relatively new and its definition changed over
the years thus resulting in a sharp increase in the number of patients
diagnosed with it.
A recent change though, resulted in a narrower definition. Thus many
people who were considered as having the disorder are suddenly
considered normative, raising significant ethical issues regarding the
power of professionals to maneuver diagnosis definitions, impacting
decisions on support and treatment for individuals.
Autism spectrum's definition includes people completely unable of
communicating and people with high cognitive and verbal ability, many of
whom claim to have just neurodiversity thus making diagnosis and
treatment unnecessary. They also object to research on changing
behavior patterns and on pre-natal genetic identification, diagnosis and
prevention in autism.
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dysfunction. The ethical debate related to this topic stems from the
dichotomy between the principle of autonomy and the principle of
beneficence. The rights of ownership and the future use for research of
biological samples with an informed consent for actual use provided are
still an unresolved problem. However the binomial of research interests in
using this data with implications for the entire community, together with
the bioethical interest of constitutionally guaranteed rights protection has
to be taken into account. From this results the authors interest to suggest
methodologies for the accurate acquisition of consent that provide to the
patient detailed information on the aims, purposes and procedures of
biomarkers investigation. The purpose has been pursued by the draft of
an application format of information sheet and an informed consent.
They point out the possible value of biomarkers as early diagnosis and
monitoring tools in neurodegenerative diseases. This formats also clarify
that the identification in blood or CSF of some markers don't express a
definitive diagnosis and underline that, at present, their validity as disease
progression index is still uncertain.
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The Human Organ Transplant Act (HOTA) in Singapore was enacted for
the removal of kidneys for the sole purpose of transplantation from
deaths arising from accidents under a system of presumed consent. Since
then, it has undergone a series of major amendments to include the
recovery of the liver, heart and cornea in the event of deaths from nonaccidental causes, and to make provisions for the inclusion of Muslims
and the removal of the upper age limit of 60 years old to increase the
number of donors. Recent amendments to this law have also included the
regulation of living donor organ transplantation and the more
controversial reimbursement of organ donors for their loss of earnings
and expenses pertaining to the transplantation. The purpose of this paper
is twofold. It traces the historical developments in Singapore that led to
the adoption of an approach in presuming the consent of individuals in
donating his organs upon death. In doing so, it addresses the challenges
that a policy of presumed consent to organ transplantation has
presented. Next, we review an instance in Singapores legal history in
which the strict prohibition on financial compensation for organ
transplantation was tested. Here, the legal justifications behind the
courts decision will be discussed in tandem with the prevailing theme of
exploitation of the poor and socially disadvantaged.
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in the light of the passionate debate which has animated public opinion.
In consideration of the consolidated position of jurisprudence on the topic
of informed consent, the underlying problems of Advance Health Care
Directives in the Italian juridical culture appear to be even more complex.
We are faced, in particular, with the difficulty of defining the right context
of cases such as biological wills, living wills and health care proxies
both in terms of their suitability and their limits. Dealing with the question
of the need for, or uselessness of specific regulations in this field is of
great importance.
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Discussion: Moral action requires the nurse to think constantly about the
important things that are happening in a nursing situation. Commitment
towards practical situations is directed to training, in order to promote the
nurse's reflective ability towards finding salience in nursing situations, but
it is also directed to the management of nursing assistance and human
resources for the initial impact that this reflexive ability has on patients
and their families' lives and on their need to be heard and assisted.
Limitations: the only case analysed does not allow generalizations.
Further research is needed to investigate how feelings generated by
emotional acceptance influence ethical decision making and moral
distress in nursing situations.
Growing data confirm that early traumatic events play a major role in the
pathogenesis of mental and physical disorders. Early traumatic
events include all kind of the repeated experiences of unsuccessful
protection by the caregivers during the development. Examples of
relational traumas are both: those in which parents are violent and
frightening and, those in which parents are absent and/or neglecting the
basic needs of comfort, protection and emotional regulation. If repeated,
in the different stages of development, all kinds of early traumatic
events could increase their pathogenic risk. In this view the separation of
parents, especially if it occurs in a conflicting and hostile condition, could
represent a traumatizing event and a risk-factor for developing emotional
and physical disorders.
THERAPEUTIC OBSTINACY
Alfredo Marinelli1,2, Sabino De Placido1
1
University Federico II, Italy
2
IRCCS Neuromed, Italy
When a Doctor is exposed, for any reason, to the linguistic expression
accanimento terapeutico his emotional and expressive reactions are
dark, in every context in which this conversation occurs. To understand
why this uneasiness is always less well concealed, and to contextualise
this problem it is important to consider a semantic realignment for entries
of a meaning that is not often shared and/or however invalidated by
additional figurative meanings they may already have.
We shall travel over the paths that lead to the birth and diffusion of the
concept of Life Prolonging Measures. The following are the cultural
bases of the concept of Health interpreted as a Fact, or a Responsibility or
a Value, which, during the practice of the medical profession may induce
behaviours which might degenerate in life prolonging measures.
This chapter has its raison dtre, not only for the relational borders that
the life prolonging measures have with euthanasia, particularly frequent
binomial in the news, but also for the borders in reference to treatment,
to the access to it, its upkeep as well as to the access and participation to
experimentation in research. Therefore the Authors want to contribute to
the END OF LIFE RIGHTS by emphasizing on less known aspects of life
prolonging measures, such as the problems linked to genetic
characteristics.
A "rational model" is represented, characterized by a humanistic and
existentialist profile based on a true pivot: the Respect of the Person. A
characteristic of the doctor who pursues this profile is the understanding
of the perspective, of the experience, also the inner experience, of the
Citizen bearer of a Pathology, as well as the transmission of this
understanding to the Citizen. This is the base of the EVOLUTION FROM CURE
TO CARE.
The aim of each Ethics Committee (EC) is to protect the rights of subjects
enrolled in a clinical trial. So it is called upon to give advice and opinions
about the fairness and ethics of scientific experimentation and
consequently its feasibility. Sometimes the ethical evaluation can relate to
epidemiological and medical-social projects that require the detection of
personal data, or to project that provide an experimentations on animals
and to those susceptible to problems of environmental ethics. We must
not overlook the fact that the EC of each Institution may also have an
advisory function so each operator in difficulty about the ethics of urgent
therapeutic choices can contact it in order to resolve their doubts.
The aim of our study is to deepen the ethical evaluations about a study
whose mission is to further the health conditions of the people who are in
the Italian Secure Hospitals (OPG) through the use of specific interviews,
which can give complete information about symptoms of psychological
distress, difficulties in the daily activities or in relationships with others,
and about the needs of hospitalized people. The main topics of interest of
the EC in evaluating this type of study are primarily the inherent ability of
hospitalized patients in the Secure Hospitals (OPG) to express a valid
consent and secondly the accordance to the International Guidelines for
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But the first and until now the only Region in Italy that introduced
through the regional law the abrogation of compulsory vaccinations has
been the Venetian Region.
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with the objective not only for a functional recovery of an injured body
part, but also for the social and work aspect.
This rehabilitation phase is one of the most important aspects of taking
care of the person, since the final objective, from the perspective of the
person who has become disabled because of work, is to restore the ability
of self-determination, and ones role in life.
The bio-psycho-social model based on ICF (International Classification of
Functioning - Disability and Health) of the WHO, represents a further
innovation adopted by INAIL Institute to analyze and maximize the
functional capability for the re-entry of the insured person, in order to see
his or her potential reflected with the companys objectives.
A protocol of a specific rehabilitation programme has been designed with
sections for the analysis and study of specific body functions and
structures related to work, together with a checklist based on the ICF
system for the discharge process.
The function aspects of this protocol that emerge are about definition,
identification and qualification of the body function/movement related to
the work activity; either characterized or by second nature, through
measurement of specific tests and reporting the persons performance
with the use of an assistive device.
We will present the data analysis of the protocol related to the
preliminary usage of the work function/movement according to the
model of ICF in a sample of over 50 cases.
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Results: Mean number of pages of the 114 assessable ICFs was 10.3 (2.5
27.5); those for industry funded trials (n. 47, 41.2%) are significantly
longer than those for investigator initiated trials (n. 67, 58.8%). Mean
number of pages were of 15.4 and 6.7 respectively (p<0.0005), with a
further increase in length in international (n. 50, 43.9%) vs national trials
(n. 64, 56.1%) with mean number of pages of 15.1 vs 6.5 (p<0.0005). The
mean Gulpease Index readability score of the 114 ICDs is 41 (3067)
irrespective of valuable variables.
Conclusions: ICFs for cancer trials seem far too complex and long to be
read and understood by an average study participant. Every effort should
be made to obtain a truly informed consent assessing the ICF readability
prior to study activation.
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119
Still, there was no single legal act regulating the issues of bioethics until
rd
October 21, 2005, when on the 33 session of UNESCOs General
Conference the Universal Declaration on Bioethics and Human Rights was
adopted. The Declaration addresses ethical issues related to medicine, life
sciences and associated technologies as applied to human beings, taking
into account their social, legal and environmental dimensions.
In Azerbaijan, fundamental changes in understanding the law took place
in the 1990s after the independence. Attempts of the modern Azerbaijani
law to replace moral regulation by legal envisages better protection of the
interests of all members of the society. In this regard, it seems urgent to
use the world experience in protecting patients' rights, taking into
account national specifics of Azerbaijan.
It should be noted that the main obstacle in implementation of the abovementioned human rights, is clearly insufficient knowledge, primarily by
the medical staff, of the content of the patients rights. At the same time,
the importance of this knowledge is understood by the medical
professionals in developed countries, where control of human rights in
health care has become as stringent as in other areas of human relations.
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This narratives talk about learning, even if yet they do not match the
clinical learning measurable skills.
This experience testifies that exists a large learning sector about
professional ethics that happens during clinical practice.
We need narrative tools in order that this experience becomes subject of
suitable reflection, therefore it will be awareness.
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Speaking the truth holds a moral value within Medical Ethics, as well as
within the Law. However, society does not often expect one to speak the
truth. For instance, we would not presume that in the case of a defendant
on trial that they would tell the truth, if this may result in a conviction.
Additionally, it is not expected for an attorney to speak the truth, in a
circumstance that it would go against his clients' interest. Moreover, in
some situations we do not want to explore the truth, such as in paternity
matters concerning illegitimate children.
On the contrary, in the Medical arena we certainly do expect physicians to
in fact embody the truth, even if this may counter their own interest. In
an event where physical harm has occurred to a patient, we expect the
physician to document everything in the medical record, even if it might
expose him to claim. Under Israeli law, you may establish an inspection
committee to examine errors in medical procedures, in which the findings
are given to the patient.
We, as a society, should reexamine our expectations of Medical
Professionals, to inform all patients about mistakes and mishaps. We
plead that such Professionals should not be granted a different set of
standards versus other fields. Furthermore, we ought to consider varying
methods of improving the Medical structure, perhaps through use of
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MEDICUS AMICUS:
PROFESSIONAL ETHICS IN THE ANCIENT WORLD
Carmen Pennacchio, University "Federico II" of Naples, Italy
pennacch@unina.it
Celso, proem. 73: cum par scientia sit, utiliorem tamen medicum esse
amicum quam extraneum, proposes an innovative interpretation of the
work of the medicus. It is the figure of the medicus gratiosus, kind,
pleasant, courteous, but also authoritative and influential to this, with
virtues such as reliability and mercy, uninterested in money, worried
about his patient and always present at critical moments.
In ancient Roman medicine there is the concept of medicus amicus,
peculiarity clearly emerges in Seneca the Youngers work and it refers to a
specific aspect of the medical practice, especially during the first imperial
era.
Seneca the Elder, analysing the work of a physician, refers an event about
the difficult relationship between father, son and stepmother, because
the son-doctor can not cure the stepmother.
There are two versions of this event. In fact Luciano di Samosata and
Seneca the Elder describe this strong controversy between father and
son, but Luciano refers to the more technical side of Greek medicine,
Seneca regards the specific aspects of medicus amicus.
The figure of the medicus amicus describes a relationship of friendship
and sympathy between the physician and the patient, highlighting the
moral aspect of ancient medicine as the most important.
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link ethics and economics to prevent futile care, everyone wins, the
society as a whole.
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1,2
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that approved (by the majority) such a trial, without solid scientific
evidence of a causal relationship between CCSVI and MS and despite the
concerns about potential risks associated with the proposed therapy
(hemorrhage, dislodgment of blood clots resulting in heart attack or
stroke, nerve damage in the neck, among others).
The remaining sense of bitter of an approval arrived at the end of an
animated discussion amongst IRB members and prompted by the
considerable public pressure of MS sufferers, who rushed off to get the
surgery by many clinics offering liberation therapy, has raised a reflection
on how to prevent similar future cases, having the common denominator
of a physician/researcher putting himself out of the good clinical practice.
The way forward seems to promote a culture of research integrity, in
which misconduct is not tolerated.
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Until a few years ago experts believed that the value of the child's
testimony was not very relevant. In recent years, however, the forensic
psychological and psychiatric literature started to show that the child,
even at a very young age, could be a reliable witness. This ability to testify
must be carefully assessed by the expert, or, preferably, by a Board of
Experts, with special skills in the specific field. The experts, starting from
the provisions of the "Carta di Noto" (2002) and the subsequent
"Protocollo di Venezia" (2007), should always keep in mind the most
recent scientific evidence in the field of developmental age. These studies
clearly show that the degree of language comprehension is lower as the
child is younger. The child under four years of age may not have the
necessary language skills: the child between four and six years provides
very few reliable answers, with understanding capacity reduced from 40%
to 65% (poor understanding of the meaning of negative, passive or
subordinate sentences, and the possibility of random answers (memories
manipulated internally and externally). In the present paper, the authors
propose to analyze the main critical issues in the methodology of forensic
investigation, in relation to a proper assessment of the reliability of the
childs testimony, especially in the age range around 4 years. The Authors
consider that the proper approach, evidence-based, has important
implications in the field of Ethics and Conduct. In fact an incomplete
evaluation conducted by untrained personnel can have a serious impact
on the assessment of the truth of the case. It can also greatly affect the
dynamics of existence of the child, his family and those who find
themselves involved in various ways. The authors conclude emphasizing
that this is a very complex research field and should be entrusted to
qualified and experienced personnel, preferably a Board of Experts in
order to take advantage of the various professional skills.
139
unable to give consent, the risks involved should not exceed a certain
minimal threshold. However, there is no agreement on the admissible
level of risks which a competent, fully informed and willing subject may
be exposed to. The aim of this presentation is to analyze this problems in
the context of the Council of Europe Oviedo Convention and its Additional
Protocols.
The Additional Protocol concerning Biomedical Research states that nontherapeutic research may only be undertaken if the research entails no
more than acceptable risk (Art. 6 sec. 2). Section 27 of the Explanatory
Report clarifies that whether or not the risks are acceptable should be
assessed by the research ethics committee and by the potential research
subject. While the right of a competent individual to make a subjective
judgment on the risk acceptability is uncontroversial, it seems difficult to
determine what objective (or inter subjective) criteria the REC should
apply. I will argue that risks of non-therapeutic research are objectively
acceptable if: (1) they are justified by the scientific and social value of the
potential research results; (2) they are necessary, meaning there is no
alternative method of comparable effectiveness and more favorable riskbenefit ratio; (3) they are proportionate to the potential benefits; (4) they
are minimized; (5) they do not involve risk of violating subjects dignity,
identity or other fundamental and inalienable rights; and (6) they do not
exceed socially acceptable level of risks an individual may consent to
carry for the sake of others.
I will show that the conditions 1-5 are prescribed expessis verbis by the
Oviedo Convention and the Additional Protocol. I will argue that the
correct interpretation of the condition 6 must take into account that: (i)
participation in research is not a moral duty but a supererogatory act; (ii)
in case of non-therapeutic research, it is done for the sake of strangers
(future patients) or impersonal values (development of generalizable
knowledge); and (iii) it has noncommercial character, meaning the
consent for participation in research should not be motivated by prospect
of obtaining financial gain or other economic benefits (although it is
permissible to compensate or reimburse research participants for their
time, inconveniences and expenses, unless it constitutes undue
influence). Therefore, in order to determine whether the risks of nontherapeutic research are socially acceptable, one should compare them
with the risks of other purely optional and noncommercial social activities
voluntarily undertaken by competent adults in order to promote welfare
of other unrelated, unknown individuals. A good example of such activity
is a living tissue or organ donation for transplantation. Taking into account
art. 10 of the Additional Protocol to the Oviedo Convention concerning
Transplantation of Organs and Tissues of Human Origin, I will claim that if
national laws allow for a living organ donation for the benefit of an
unrelated recipient, the risks of such donation may be used by national
RECs as comparators for acceptable risks of non-therapeutic research
involving healthy volunteers. If there is no such legal option, living tissue
donation may serve as such a comparator.
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144
issued by the Supreme Court seeking in some way to facilitate the daily
lives of the partners extending forms of protection and warranty. Besides
in Italy, marriage is not even allowed between persons of the same sex,
although it emerges a clear need to remove from legislation all forms of
discrimination and unequal treatment between heterosexual and
homosexual citizens, on the basis of sexual orientation and in accordance
to the application of the principle of equality laid down in Article. 3 of the
Constitution. Anyway, to guarantee the same legal value to both gays and
lesbians feelings, a "simple" modification of the Civil Code would be
needed that is the berating of the terms "husband" and "wife", replaced
by the neutral word of "spouses" (Article 107, paragraph I, art. 108
paragraph I, Art.143, paragraph I. / art. 294, paragraph II) and expand the
scope of Article. 90 Civil Code, inserting art. 90a, stating that "marriage is
subject to the same conditions and the same effect regardless of whether
the spouses are of different or the same sex." There are many bills filed in
this regard in Parliament which to date have not become laws.
Ethics as process and practice. Internal Medicine Journal 2004; 34: 355
357) from actions to actors, from single decisions to the stories we are
involved in as related persons, a narrative approach to ethical reasoning is
required. The basic action of ethics in this perspective is not to apply
moral principles to cases represented in medical facts but, on the one
hand, to think about everyday existential issues on the basis of stories,
and, on the other hand, to connect with other persons through stories.
The presentation will outline such an approach to clinical ethics
consultation regarding methodological and organizational aspects, and its
opportunities and limitations.
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146
These cases represent a spectrum of very sick patients who, while in lifethreatening conditions, consciously refused lifesaving medical treatment,
at their own demise. These cases pin point the dilemma between
patients' autonomy and medical paternalism: what are the boundaries of
the best interest that any patient may have, is a patient in critical
condition capable of making rational decisions and who is responsible to
observe the "reasonable patient test" in an urgent situation, and finally,
to what extent should a society protects its member from being the victim
of his fatal decision.
147
148
these could (claim the critics) be better spent on young people. It has also
been claimed that 'old people have a duty to die'; and that 'old people
refuse to die'.
This paper explores prolonged longevity, its value and its discontents; the
paper examines the future of ageing from the perspective of stem cell
research. And observes that at present, active ageing may postpone
and/or avoid many of the conditions which, prolonged longevity is usually
plagued with.
Curiosity is most probably the main reason for the success of Gunther von
Hagens Body Worlds: the original exhibition of real human bodies. This
first public anatomical exhibition of human corpses that have been
plastinated has attracted millions of visitors in the last ten years. The
plastination process involves replacing the water and fat of the body with
certain plastics that can be touched, has no smell or decay and even
preserves most of the original sample. Body Worlds was first exhibited in
Tokyo in 1995, since then the exhibition has been hosted by more than 50
museums and venues and recently in South Africa. The Body Worlds
exhibition takes its visitor through a journey of more than 200 specimens
including 20 full body plastinates as well as individual organs (displaying
the difference between healthy lungs and lungs affected by cancer). The
various full body plastinates are posed in different positions to display
how the human body works, they vary from the chess player with his
brain split open to display the brain in action, the runner with his
muscles falling off the bones to display the working of the muscles and
the controversial pregnant women with her womb cut open to show her
eight month old fetus. Von Hagens himself believes his exhibition has
educational value, referring to it as the democratization of anatomy:
anatomy for the masses as opposed to anatomy for the academic elite.
Many others describe it as art and it has also attracted the definition of
edutainment.
The legal process in South Africa when donating a whole body will be
analysed and the question will be asked whether a person should have
the right to donate his or her body for such an exhibition taking
cognizance of the right to self determination and personal autonomy. It
Scientists responsible for the Cancer registry in Iceland have studied a risk
gene for breast and ovarian cancer; the Icelandic variant of the BRCA gen.
Individuals with this gene carry a lifetime risk of 70% for cancer. Women
diagnosed with breast cancer and their close relatives were invited for
genetic analysis. Those carrying the risk gene were invited for careful
genetic counseling and to attend follow up every 6 months. Some of these
women have chosen to have their breasts removed in order to minimize
their risk. In all, 174 women have been participating in this project.
Iceland has a population of 320.000 individuals. DeCode Genetics, a
genetic research laboratory based in Reykjavik has for years studied the
genetics of the population through various scientific projects. Scientists of
the laboratory have recently informed that it is technically feasible to
analyse all individuals of the country for the aberrant BRCA gene. This is
possible through three channels available to the company; whole genome
analysis of more than 2000 individuals, imputation of this information into
genetic information of more than 100.000 individuals and subsequently
through the genealogical database of the whole population. It has been
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150
were beneficial but are now detrimental. As well many scientists are
looking at genes to try and establish evidence of race down to almost
tribal differences amongst people.
This has raised a number of ethical problems that have not yet been fully
acknowledged:
1. The actual treatment of human remains-these are not objects they are
people and from historical times will have living known descendants.
Should there be a universal reburial protocol? What constitutes
human remains? Does DNA amplified by PCR remain part of the donor
and as such requires reburial.
2. Religious and cultural considerations: The Jewish Orthodox religion
prohibits disturbing human remains except for Pikuah Nefesh (if it
helps others), the Buddhists have ancestor worship, the Australian
aboriginal have their particular set of values.
3. Use of DNA for ethnic and racial profiling this may be a frightening
development the Nazis used forms of Pseudo science to prove
ethnicity. How much more dangerous would this have been had they
unearth an ancient Jewish cemetery and found no matter how wrong
a Jewish, or Romany Gene would the Turkish Genocide of Armenians
been made even more horrific had their scientists found an Armenian
gene. There is now an accepted Cohen gene that appears to date back
to antiquity- could the presence of such a gene have been enough
proof to cause a persons to be condemned to death? Yet the gene is
also present with significant frequency amongst a tribe of Bantus in
South Africa.
We have for over 20 years been studying DNA looking for the evolution of
bacteria especially TB and Hansens disease and more recently host
resistance/susceptibility genes and certain cancer susceptibility genes in a
variety of human remains from the 18th Cent Hungarian mummies from
Vac, 5th cent A D from Sudan as the Jaseon dynasty from Korea.
This paper will discuss how our finding may be relevant to todays medical
ethics and how one overcomes cultural and religious problems one can
face in such research.
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154
survey was made in the hospital and home care facilities of Azienda USL in
Aosta Valley, where a greater presence of foreign users is recorded,
administering an anonymous questionnaire to 360 nurses of Italian origin
with no distinction of gender, age, experience and school attendance. The
results confirmed that the problem is real: there is difficulty in taking care
of foreign patients and nurses show specific education needs to fill in gaps
that prevent them from caring with competence for people belonging to
other cultures.
II. Incorporating Bioethics in the Medical curriculum, right from the first
day of medical education and, III. Enforcement of the ethical canons,
among practising physicians and researchers. These efforts can be
eminently implemented at the field level by the Project Evaluation
Committee and the Institutional Ethics Committee (Institutional review
boards). These committees must include lay men, jurists and
philosophers. Standard Operating Procedures must be in place and must
be scrupulously followed. Further, it is imperative to endow these
committees with adequate disciplinary powers.
One aphorism of Hippocrates summarises all the above. Art is long,
vitality is brief, occasion precipitous, experiment perilous, judgment
difficult [Latin: Vita brevis, ars longa, occasion praeceps, experimentum
periculosum, judicium difficile].
ORGAN PROCUREMENT:
SPANISH TRANSPLANT PROCUREMENT MANAGEMENT
J.V. Torregrossa, C.A. Ballest, M. Manyalich, C. Mestres, G. Pez,
R. Valero, M.P. Gmez, Hospital Clinic, University of Barcelona, Spain
mmanya@clinic.ub.es
Transplantation is an accepted therapeutic option to save or improve the
quality of life when organ failure occurs or tissue replacements are
needed. However, the lack of organs is the major limitation. The deceased
organ procurement organization and professionals provide the solution to
this international problem. We identify the elements involved in the
organ procurement management process to analyze the possibility of
implementation of deceased organ procurement for a transplantation
program. While the donation rates are subject to several negative factors
including religious, economic, cultural, and legal issues, the existence of
well-trained professionals may considerably increase them. Professional
training in organ donation along with the establishment of a solid
organizational system has been identified as the crucial factor in
developing efficient organ donation and transplantation programs.
155
156
As part of the Italian case law has developed on the issue of consent to
assisted procreation, is of particular interest that related to cases of
heterologous fertilization, which is prohibited by Italian law. The most
recent rulings on the subject (from last Court of Cassation. Sect. 1 Civil
Sentence no. 11644 of 2012) founded the protection of offspring on the
consensus on medically assisted procreation heterologous expressed by
the parent for facta concludentia, by giving precedence to the quality
recognized as a son over the principle of truth.
In conclusion, the possibility of making use of techniques of medically
assisted procreation leads to significantly different evaluation of the
"principle of truth" with respect to "the principle of legitimation."
157
expenditure. Two-thirds of the population lives in poverty (below onedollar-per-day) and also lack adequate access to basic health care. As a
result, to give an example, Nigeria's under-five mortality is extremely high
(171 per 1000 live births). Nigerias situation is similar to those of other
countries in Sub-Saharan Africa.
While these facts raise questions of health care justice, bioethics in Africa
has in the past focused mostly on research ethics (e.g. involving patients
in clinical trials). Relevant debates were often limited to questions of
autonomy and informed consent in patient-physician relationship.
Furthermore, global Bioethics has avoided questions of health inequalities
in Africa.
This paper intends to establish the place of just health care in Nigeria, as
an essential background against which other bioethics initiatives may
enhance health care benefits to the majority poor in Africa. It shall refer
to Norman Daniels theory of fair equality of opportunity in health care as
a relevant starting point, and suggest an outline of an African theory of
health care justice for adoption in Nigeria.
158
expects to pay a high price, standing all night long without food and
holding their tongue.
Thats how two thousand years ago Lucio Anneo Seneca, philosopher of
ancient Rome, described the condition of the slaves in his Epistulae
morales ad Lucilium. Unfortunately nowadays seems that nothing has
been changed. We can meet on the street crippled and handicapped
people forced to ask for charity under the pressure of cruel ruthless
persecutors. They have to show their poor bodies such an embarrassing
merchandise, losing their own dignity
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3,4
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1,2
Bioethics, Medical
Ethics and Health Law
Poster Presentations
(by day and by presenter)
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