Global Health Ethics Seminar: Epid 898
Fall semester 2010, Mondays, 12:00-1:50
MC 2101-G, UNC School of Public Health
Co-instructors:
Stuart Rennie, Research Assistant Professor, Department of Social Medicine
(stuart_rennie@unc.edu)
Frieda Behets, Associate Professor, Department of Epidemiology
(frieda_behets@unc.edu)
Theme: Global health research and ethics
Background
Given the fundamental value of health, practically no one would question the ethics of
improving the health of individuals and communities through health-related research, at
least in the abstract. However, in the practice of health research, even the best intended
research projects (led by the most experienced researchers) can give rise to difficult
ethical challenges. Some of these challenges are familiar, such as difficulties in gaining
‘genuine’ informed consent among non-literate or research naïve populations. Other
problems may be less obvious. When health research is conducted in resource-poor
settings, the familiar challenges may be magnified, while new and unexpected problems
may arise.
Health research generally takes place against a background of inequalities of various
kinds. Research is often motivated the desire to reduce health inequalities – within and
between societies -- that themselves reflect unequal distributions of social, economic and
political power. At the same time, the medical and public health research enterprise itself
is marked by its own inequalities: inequalities in power between research institutions
and communities in which research takes place; between researchers and research
subjects, between research institutions and local communities, between research funders
and researchers, and between researchers and their collaborating international research
partners. In international health research, researcher and participant may live, literally,
in different worlds.
These and other inequalities generate many of the value conflicts that permeate the
practice of global health research. The task of research ethics is to identify and analyze
these conflicts, and attempt to negotiate reasonable responses to them, while taking into
account relevant principles, regulations and laws, and acknowledging the social, cultural,
economic and political roots of research ethics conflicts. Because they focus narrowly on
the protection of individual subjects and meeting institutional regulations, completion of
IRB applications and fulfillment of ‘ethics training’ requirements do not sufficiently
prepare students for the ethical complexities of research.
Methods
This seminar will take a ‘readings, cases, and codes’ approach. We will analyze and
critically discuss articles that deal with some of the ethical challenges raised by the global
health research. The course readings will also provide further background to frame the
problems and/or place them within their social, political or historical context. The
content of the readings will be supplemented by case studies in order to place greater
focus to certain critical issues. Relevant domestic and international codes may (or may
not) provide helpful ethical guidance for the kinds of ethical conflicts present. Ethics
involves argument and debate: there will be ample room for class discussion.
Goals
By the end of the seminar, students should have a greater awareness of and sensitivity to
the myriad ethical challenges that permeate domestic and international health research.
Students during the course of the semester will make some progress in identifying and
thinking about ethical problems, and thereby develop their own personal ethical vision.
By engaging in a thoughtful and hands-on process of balancing ethical considerations in
research, students will enhance the ethical dimension of their role as public health
professionals. The seminar may also help students improve their research planning from
an ethical and regulatory perspective.
Requirements
The seminar requirements are as follows:
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Each student will prepare a one-page (typed) critical summary of the readings for
each seminar session, to be handed in to seminar leaders after each session
Individual students will be selected randomly to lead discussion in seminar
sessions by presenting and commenting on the ethical issues in the readings
Students will be asked to submit a 8-10 page paper on a research ethics topic at
the end of the semester; students will first submit a short paper proposal (in the
form of a half-page abstract)
In the last seminar session, students will work in groups to present a research
ethics case, analyze the values in conflict, and to defend a position on the
described problems
Seminar attendance is required; students must present seminar leaders with
valid excuses for all absences
Grading: Grade distribution: 50% on paper, 15% on individual presentation, 15% on
group presentation, 25% on participation in discussions. The top third of students in the
class will be eligible for an honors grade.
Readings
Articles will be posted on Blackboard to accompany each seminar session. Portions of the
book Ethical Issues in International Biomedical Research: A Casebook (Lavery, Grady,
Wahl and Emanuel, eds., Oxford University Press, 2007) in some sessions will be used
as a resource.
This 2 credit seminar can be used to fulfill requirements of the Global Health
Certificate or the Certificate in Public Health Ethics.
Seminar schedule
Date
30/08
13/09
Topic
Introductory session
What is (research)
ethics?
Readings
Rachels (1994) Can ethics provide answers? In:
Can ethics provide answers and other essays in
moral philosophy.
Emanuel et al. (2004) What Makes Clinical Research
in Developing Countries Ethical? The Benchmarks of
Ethical Research. Journal of Infectious Diseases
198:930-7.
World Medical Association (2008): Declaration of
Helsinki. Ethical principles for medical research
involving human subjects.
Tausig et. al. (2007) The bioethics of medical
research in very poor countries. Health: An
interdisciplinary journal for the study of health,
illness and medicine 11(2): 145-161.
20/09
Ethics, global
research and
responsiveness to
local health needs
Participants in the 2001 Conference on Ethical
Aspects of Research in Developing Countries. (2003)
Ethics. Fair benefits for research in developing
countries. Science 298(5601): 2133-4.
Ballantyne (2010) How to do research fairly in an
unfair world. American Journal of Bioethics 10(6):
26-35.
London AJ (2005) Justice and the human
development approach to international research.
Hastings Center Report 35(1): 24-37.
27/09
The ethics of
community
engagement in
research
MacQueen (2001) What is community? An evidencebased definition for participatory public health. AJPH
91(12): 1929-38.
Dickert and Sugarman (2005) Ethical goals of
community consultation in research. AJPH 95(7):
1123-1127.
Geissler et. al. (2008) ‘He is now like a brother, I can
even give him some blood’ -- relational ethics and
material exchanges in a malaria vaccine ‘trial
community’ in The Gambia. Social Science and
Medicine 67: 696-707.
Buchanan et. al. (2007) Ethical issues in communitybased participatory research: balancing rigorous
research with community participation in community
intervention studies. Progress in Community Health
Partnerships 1(2): 153-160.
04/10
Ethical challenges
with informed
consent (1)
Code of Federal Regulations, Part 46: Protection of
Human Subjects: 45 CFR 46.116 and 46.117.
Doherty (2006) Form over substance: the inadequacy
of informed consent and ethical review for Thai
injection drug users enrolled in HIV vaccine trials.
Pacific Rim Law and Policy Journal 15: 101-136.
Chokshi et. al. (2007) Valid consent for genomic
epidemiology in developing countries. PLoS Medicine
4(4): e95.
11/10
Ethical challenges
with informed
consent (2)
Gikonyo (2008) Taking social relationships seriously:
lessons learned from the informed consent practices
of a vaccine trial on the Kenyan coast. Social Science
and Medicine 67: 708-20.
Tolich (2009) The principle of caveat emptor:
confidentiality and informed consent as endemic
dilemmas in focus group research. Bioethics inquiry
6: 99-108.
Van den Borne (2007) Using mystery clients to assess
condom negotiation in Malawi: some ethical
concerns. Studies in Family Planning 38(4): 322330.
18/10
Equipoise and
standard of care in
clinical trials
Freedman (1987) Equipoise and the ethics of clinical
research. NEJM 317(3): 141-5.
Karim et. al. (2010) Timing of initiation of
antiretroviral drugs during tuberculosis therapy.
NEJM 362(8): 697-706.
Philpott and Schuklenk (2010) A study that should
never have been done. Hastings Forum.
Cohen (2010) Bioethicists assail a celebrated TB/HIV
treatment trial. Science 328: 799-800.
25/10
Ethics committees
and global health
research
London, L (2002) Ethical Oversight of Public Health
Research: Can Rules and IRBs Make a Difference in
Developing Countries? AJPH 92(7): 1079–1084.
Guest facilitator:
Prof. Lawrence
Rosenfeld
Kim et. al. (2009) Pruning the regulatory tree.
Nature 457: 534-5.
Gilman RH, Garcia HH (2002) Ethical review
procedures for research in developing countries: a
basic presumption of guilt. CMAJ 171(3): 248.
Mfutso-Bengu and Taylor (2002) Ethical juridictions
in biomedical research. Trends in Parasitology 18(5):
231-4.
Rennie (2004) Is there a place for benevolent
deception? Trends in Parasitology 18(5): 231-4.
01/11
Standard of
prevention and
responsibility for
infection in HIV
prevention research
UNAIDS (2007) Ethical considerations in biomedical
HIV prevention trials. Guidance Points 13 and 14.
Weijer and LeBlanc (2006) The balm of Gilead: is the
provision of treatment to those who seroconvert in
HIV prevention trials a matter of moral obligation or
moral negotiation? J Law Ethics 34(4): 793-808.
Schuklenk (2007) HIV vaccine trials: reconsidering
the therapeutic misconception and the question of
what constitutes trial related injuries. Developing
World Bioethics 7(3): 2007.
Lo et. al. (2007) The obligation to provide
antiretroviral treatment in HIV prevention trials.
AIDS 21(10): 1229-1231.
08/11
(Unduly?)
influencing
vulnerable
populations in
research
Emanuel (2006) Undue inducement: nonsense on
stilts? American Journal of Bioethics 5(5): 9-13.
Grant and Sugarman (2004) Ethics in human
subjects research: do incentives matter? J Med
Philosophy 29(6): 717-738.
Dickert and Grady (1999) What’s the price of a
research subject? Approaches to payment for
research participation. NEJM 341: 198-203.
Compensation for Families who Consent to Research
for their children in a study of malaria mortality in
Malawi (2007). Case study #17 in: Ethical Issues in
International Biomedical Research.
15/11
Research involving
minors
Code of Federal Regulations, Part 46: Protection of
Human Subjects: 45 CFR 46.401 to 46.409.
Kopelman (2000) Children as research subjects: a
dilemma. Journal of Medicine and Philosophy 25:
745-64.
Duncan et. al. (2009) Is my mum going to hear this?
Methodological and ethical challenges in qualitative
health research with young people. Social Science
and Medicine 69: 1691-1699.
Vreeman et. al (2009) Pediatric assent for a study of
antiretroviral therapy dosing for children in Western
Kenya: a case study in international research
collaboration. Journal of Empirical Research on
Human Research Ethics.
22/11
Ancillary care
responsibilities
Richardson (2007) Gradations of researchers’
obligations to provide ancillary care for HIV/AIDS in
developing countries. AJPH 97(11): 1956-1961.
Dickert et. al. (2006) Ancillary care responsibilities in
observational research: two cases, two issues. Lancet
368: 874-77.
Hyder and Merritt (2009) Ancillary care for public
health research in developing countries. JAMA
302(4): 429-431.
Hooper (2010) Ancillary care duties: the demands of
justice. Journal of Medical Ethics (early online
article, July 2010).
29/11
Post-research
responsibilities
Grady (2005) The challenge of assuring continued
post-trial access to beneficial treatment. Yale J.
Health Policy and Ethics 425.
Merritt and Grady (2006) Reciprocity and post-trial
access for participants in antiretroviral therapy trials.
AIDS 20(14): 1791-1794.
Zong (2008) Should post-trial provision of beneficial
experimental interventions be mandatory in
developing countries? Journal of Medical Ethics 34:
188-192.
06/12
Group presentations
This syllabus may be subject to change. Students will be notified of all significant
changes in advance either in class or via Blackboard.
Who are we?
The Global Health Ethics seminar is part of a UNC project entitled Strengthening
Bioethics Capacity and Justice in Health, supported by a Fogarty International
Center/NIH training grant since 2004. The mission of this project is to strengthen
bioethics education and research in Francophone Africa, and the project has helped
established the first bioethics unit in Central Francophone Africa: the Centre
Interdisciplinaire de Bioéthique pour l’Afrique Francophone (CIBAF) in Kinshasa,
capital of the Democratic Republic of Congo. Members of CIBAF have led in research
ethics training in the Republic of Congo, Burundi and Madagascar. More information
about the project can be found at our website: http://fogartybioethics.unc.edu
The Global Bioethics Blog, also a product of this project, was established in 2005. The blog is
devoted to ethical issues related to health research, policy and practice around the world, with
a particular focus on sub-Saharan Africa. Visit the English language version of the blog at:
http://globalbioethics.blogspot.com., or its Francophone counterpart at
http://bioethiqueafriquefranophone.blogspot.com.