Monday, July 1- Friday July 5
1:30pm- 5:00pm, Room 3204
Dr. Nancy Kass, Bioethics
Institute and Department of Health Policy and Management, Johns
Hopkins School of Public Health
Dr. Andrea Ruff, Department of International Health,
Johns Hopkins School of Public Health
Dr. Suzanne Maman, Department
of International Health, Johns Hopkins School of Public Health
Rev. John-Appiah Poku, JHU-Fogarty African bioethics
fellow and Head of the Department of Behavioral Sciences
at the School of Medical Sciences, Kwame Nkrumah University of Science
and Technology, in Kumasi, Ghana.
Dr. Godfrey Tangwa, JHU-Fogarty African bioethics
fellow and Associate Professor of Philosophy at the University
of Yaounde 1, in Yaounde, Cameroon.
Ms. Paulina Tindana, JHU-Fogarty African bioethics
fellow and IRB Administrator of the Navrongo Health Research
Center in Navrongo, Ghana.
OPTIONAL: This objective
of this course is to increase participants’ awareness of and
ability to reason through ethical issues that arise in the conduct
of international human subjects research. This course will introduce
participants both to ethics principles and regulatory requirements
that relate to these research dilemmas. The course will include
discussion of several cases to enable students to work through ethical
challenges posed in real life.
The course may be taken for credit or on a pass/fail basis.
Students taking the course for credit will be evaluated on the basis
of their attendance and participation in the class, as well as on
the written assignment. The written assignment is a case analysis.
The assignment will be distributed in class on Wednesday, July 3
and will be due Monday July 8 (by email to firstname.lastname@example.org).
There also will be in-class exercises that all students are expected
to complete. In-class exercises will be completed as group exercises,
while the final assignment must be done on your own.
The course packet contains readings that pertain to each
day’s topic, however, if you are interested in a particular
topic and would like more readings, please check with one of the
course instructors listed above.
MONDAY, JULY 1:
Bioethics principles, Codes and Regulations of research ethics;
and “Where Science Meets Ethics in Clinical Trials”
||Welcome, introductions, course information
||Lecture: Dr. Nancy Kass: principles of bioethics,
codes and regulations of research ethics
||Dr. Anthony Japour, Abbott Pharmaceuticals: “Where
Science Meets Ethics in Clinical Trials”
- Tom L. Beauchamp and LeRoy Walters, Eds. Contemporary
Issues in Bioethics. (Third Edition.) Belmont: Wadsworth
Publishing Company, 1989. Excerpt from Chapter 1: Ethical Theory
and Bioethics. (pp. 28-34, Major Ethical Principles.)
- Michele Barry. Ethical Considerations of Human Investigation
in Developing Countries: The AIDS Dilemma. The New England
Journal of Medicine. 319 (16):1083-1086, 1988.
- Emanuel EJ, Wendler D, Grady C. (2000). What makes clinical
research ethical? JAMA 283(20): 2701-11
- Christoper C. Whalen, Robin Huebner and Jerrold J. Ellner.
A Trial of Three Regimens to Prevent Tuberculosis in Ugandan Adults
Infected with the Human Immunodeficiency Virus. The New England
Journal of Medicine. 337:801-808, 1997.
Tuesday, July 2: Privacy
and Confidentiality; Ethical Issues in Study Design
||Dr. Michael Sweat,
Department of International Health, Johns Hopkins School of
Public Health: “Privacy and Confidentiality in U.S. and
||Dr. Steven Goodman, Departments
of Oncology, Epidemiology, and Biostatistics, Johns Hopkins
Schools of Medicine and Public Health: “Ethical Issues
in Study Design”
||Malaria Vaccine Case: group discussion
- Levine RJ, Ethics and Regulation of Clinical Research.
New Haven: Yale University Press, 1988, Chapter 7: “Privacy
and Confidentiality,” pp. 163-181.
- Hellman S and Hellman D. (1991). Of mice but not men: problems
of the randomized clinical trial. NEJM 324: 1585-9.
- Passamani E. (1991). Clinical trials- Are they ethical? NEJM
- Lurie P and Wolfe S. (1997). Unethical trials of interventions
to reduce perinatal transmission of the human immunodeficiency
virus in developing countries. NEJM, 337(12): 853-856.
- Varmus H and Satcher D. (1997). Ethical complexities of conducting
research in developing countries. NEJM, 337(14): 1003-1005.
Wednesday, July 3: Informed
|| Dr. Nancy Kass,
Fundamentals of informed consent
||Dr. Chris Beyrer, Departments
of Epidemiology and International Health, Johns Hopkins School
of Public Health: “Where human rights and research ethics
||Consent exercise (small groups)
- Warren Reich (ed.). Encyclopedia of Bioethics, Volume 3, revised
ed. New York: Simon & Schuster, 1995, pp. 1232-1241.
- Larry Gostin (1995). Informed consent, cultural sensitivity,
and respect for persons. Journal of American Medical Association,
- Godfrey Tangwa, (2000). The traditional African perception of
a person: Some implications for bioethics. Hastings Center
Report 30(5): 39-43.
- A. Leach, S. Hilton, B. M. Greenwood, Manneh E., Dibba B., Wilkins
A. and E. K. Mulholland. An evaluation of the informed consent
procedure used during a trial of a Haemophilus influenzae type
B conjugate vaccine undertaken in The Gambia, West Africa. Social
Science and Medicine. 48:139-148, 1999.
- Chris Beyrer and Nancy E. Kass. Human rights, politics, and
research ethics review. The Lancet. (In press)
- Carel B. IJsselmeiden and Ruth R. Faden. Research and Informed
Consent in Africa - Another Look. The New England Journal
of Medicine. 326 (12):830-833, 1992.
- Robert J. Levine. Informed Consent: Some Challenges to the
Universal Validity of the Western Model. Law, Medicine and
Health Care. 19 (3-4):207-213, 1991.
- JHU Committee On Human Research Checklist for Reviewers
Thursday, July 4: Institutional
Review Boards/Ethics Review Boards
||Dr. Nancy Kass,
U.S. requirements for the IRB
||Ms. Paulina Tindana, case example
of establishing an IRB in Ghana
||Dr. Andrea Ruff, Experiences
and lessons from the field
||Small group case discussion: rotavirus case as
“mock IRB” exercise
||Reporting of small group discussions to entire
- Richard Love and Norman Fost. Ethical and Regulatory Challenges
in Randomized Control of Trial of Adjuvant Treatment for Breast
Cancer in Vietnam. Journal of Investigative Medicine.
45 (8):423-431, 1997.
- Nicholas A. Christakis and Morris J. Panner. Existing International
Ethical Guidelines for Human Subjects Research: Some Open Questions.
Law, Medicine & Health Care. 19 (3-4):214-221, 1991.
- World Health Organization. Operational Guidelines for Ethical
Committees That Review Biomedical Research. Publication
no. TDR/PRD/ETHICS/2000.1 Geneva, 2000.
Friday, July 5: Risks and
benefits; Justice; Open discussion of situations from the field
||Dr. Nancy Kass,
Risks and benefits; Justice in research
||Open discussion of experiences from the field
- S. R. Benatar. Reflecions and recommendations on research ethics
in developing countries. Social Science & Medicine.
- Leonard Glantz, George J. Annas, Michael A. Grodin and Wendy
K. Mariner. Research in Developing Countries: Taking Benefit Seriously.
Hastings Center Report. 28 (6):38-42, 1998.
- P. Garner, R. Kale, R. Dickson, T. Dans, and R. Salinas. Getting
Research Findings into Practice: Implementing research findings
in developing countries. British Medical Journal. 317:531-535,
August 22, 1998.
- A. Costello and A. Zumla. Moving to research partnerships in
developing countries. British Medical Journal. 321:827-829,
September 30, 2000.
- Levine RJ. Ethics and Regulation of Clinical Research,
New Haven: Yale University Press, 1988, Chapter 3, “Balance
of Harms and Benefits”, pp. 37-65.
- Anna Mastroianni, Ruth Faden, and Daniel Federmen (eds.) Women
and Health Research, Vol I, Washington, D.C: National Academy
Press, 1994, Chapter 3, “Justice in Clinical Studies: Guiding
Principles,” pp. 75-83.
- CIOMS. Ethics and Research on Human Subjects. International
Guidelines. XXVI CIOMS Conference, Geneva, Switzerland, 1992.
For draft of revised CIOMS guidelines, please refer to:
- OPRR Reports. Protection of Human Subjects. Title 45, Code of
Regulations, Part 46. Department of Health and Human Services,
USA. Revised June 18, 1991. Reprinted March 15, 1994.
- The Belmont Report. Ethical Principles and Guidelines for the
Protection of Human Subjects of Research. The National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research, USA. April 17, 1979.
- Declaration Of Helsinki. World Medical Association. Adopted
by the 18th World Medical Assembly, Helsinki, Finland, 1964. Amended
1975, 1983, 1989, 2000.
- Universal Declaration of Human Rights. Adopted 1948 by the General
Assembly of the United Nations.