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Curriculum: Established Programs

INTERNATIONAL RESEARCH ETHICS

Course Syllabus
Monday, July 1- Friday July 5
1:30pm- 5:00pm, Room 3204

 

Course Faculty:

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

Discussion Leaders:

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.

Evaluation
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 nkass@jhsph.edu). 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.

Readings
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”

Schedule

1:30- 2:00 Welcome, introductions, course information and mechanics
2:00- 3:15 Lecture: Dr. Nancy Kass: principles of bioethics, codes and regulations of research ethics
3:15-3:30 Break
3:30-5:00 Dr. Anthony Japour, Abbott Pharmaceuticals: “Where Science Meets Ethics in Clinical Trials”

Readings:

  1. 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.)
  2. Michele Barry. Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma. The New England Journal of Medicine. 319 (16):1083-1086, 1988.
  3. Emanuel EJ, Wendler D, Grady C. (2000). What makes clinical research ethical? JAMA 283(20): 2701-11
  4. 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

Schedule

1:30-2:45 Dr. Michael Sweat, Department of International Health, Johns Hopkins School of Public Health: “Privacy and Confidentiality in U.S. and International Studies”
2:45-3:45 Dr. Steven Goodman, Departments of Oncology, Epidemiology, and Biostatistics, Johns Hopkins Schools of Medicine and Public Health: “Ethical Issues in Study Design”
3:45-4:00 Break
4:00-5:00 Malaria Vaccine Case: group discussion

Readings:

  1. Levine RJ, Ethics and Regulation of Clinical Research. New Haven: Yale University Press, 1988, Chapter 7: “Privacy and Confidentiality,” pp. 163-181.
  2. Hellman S and Hellman D. (1991). Of mice but not men: problems of the randomized clinical trial. NEJM 324: 1585-9.
  3. Passamani E. (1991). Clinical trials- Are they ethical? NEJM 324: 1589-1592.
  4. 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.
  5. Varmus H and Satcher D. (1997). Ethical complexities of conducting research in developing countries. NEJM, 337(14): 1003-1005.

Wednesday, July 3: Informed Consent

Schedule

1:30-2:15 Dr. Nancy Kass, Fundamentals of informed consent
2:15-3:30 Dr. Chris Beyrer, Departments of Epidemiology and International Health, Johns Hopkins School of Public Health: “Where human rights and research ethics intersect”
3:30-3:45 Break
3:45-5:00 Consent exercise (small groups)

Readings:

  1. Warren Reich (ed.). Encyclopedia of Bioethics, Volume 3, revised ed. New York: Simon & Schuster, 1995, pp. 1232-1241.
  2. Larry Gostin (1995). Informed consent, cultural sensitivity, and respect for persons. Journal of American Medical Association, 274(10): 844-45.
  3. Godfrey Tangwa, (2000). The traditional African perception of a person: Some implications for bioethics. Hastings Center Report 30(5): 39-43.
  4. 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.
  5. Chris Beyrer and Nancy E. Kass. Human rights, politics, and research ethics review. The Lancet. (In press)
  6. 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.
  7. 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.
  8. JHU Committee On Human Research Checklist for Reviewers

Thursday, July 4: Institutional Review Boards/Ethics Review Boards

Schedule

1:30-2:00 Dr. Nancy Kass, U.S. requirements for the IRB
2:00-2:30 Ms. Paulina Tindana, case example of establishing an IRB in Ghana
2:30-3:00 Dr. Andrea Ruff, Experiences and lessons from the field
3:00-3:30 Discussion
3:30-3:45 Break
3:45-4:45 Small group case discussion: rotavirus case as “mock IRB” exercise
4:45-5:00 Reporting of small group discussions to entire class

Readings:

  1. 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.
  2. 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.
  3. 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

Schedule

1:30-3:00 Dr. Nancy Kass, Risks and benefits; Justice in research
3:00-3:30 Discussion
3:30-3:45 Break
3:45-5:00 Open discussion of experiences from the field

Readings:

  1. S. R. Benatar. Reflecions and recommendations on research ethics in developing countries. Social Science & Medicine. 54:1131-1141, 2002.
  2. 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.
  3. 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.
  4. A. Costello and A. Zumla. Moving to research partnerships in developing countries. British Medical Journal. 321:827-829, September 30, 2000.
  5. Levine RJ. Ethics and Regulation of Clinical Research, New Haven: Yale University Press, 1988, Chapter 3, “Balance of Harms and Benefits”, pp. 37-65.
  6. 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.

REFERENCE: Codes and Guidelines

  1. CIOMS. Ethics and Research on Human Subjects. International Guidelines. XXVI CIOMS Conference, Geneva, Switzerland, 1992. For draft of revised CIOMS guidelines, please refer to: http://www.cioms.ch/frame_guidelines_january_2002.htm
  2. 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.
  3. 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.
  4. Declaration Of Helsinki. World Medical Association. Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964. Amended 1975, 1983, 1989, 2000.
  5. Universal Declaration of Human Rights. Adopted 1948 by the General Assembly of the United Nations.

Last Updated: 11/25/02

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