IRB Case Studies

Cases in Research Ethics

Risking oneself for another is noble; being tricked into running such a risk is to be abused. The ethical issues in research on human subjects were at the core of the modern bioethics movement at its beginning and they remain vexed today. They have been at the heart of the work of the Yale Interdisciplinary Center for Bioethics at least since our fortunate receipt of support from the Donaghue Foundation in 2004.

One part of our work under that grant has been the development of a series of case studies rooted in the work of hospital IRBs in Connecticut. IRB members drafted case narratives reflecting their experience. These were analyzed and discussed with them and our colleagues. Then we have solicited commentaries. The results appear in the cases that follow. We hope that they will be read with profit by IRB members, researchers, and persons otherwise interested in the study of research ethics.

We will eagerly await commentary either on specifics of what the commentators say or on the entire enterprise. We would also be delighted if someone should want to volunteer a case narrative. We can’t guarantee that we’ll use everything submitted, of course, but the field is rich and we’d certainly like a look. Comments either for consideration for publication or just for our information may be submitted to

Case 1: Payments to subjects who are substance abusers

Comment: Fair compensation or undue inducement?

By Angela Ballantyne, Donaghue Visiting Scholar 2007-2008

Comment: On withholding payments until study completion

By David Smith, Director

Comment: Motives and protection

By R. Douglas Bruce, Assistant Professor of Internal Medicine (AIDS), Yale School of Medicine and Director, South Central Rehabilitation Center

Case 2: Community IRB members’ religious conflict of interest

Comment: “Community” members and conflict

By Robert J. Levine, Senior Scholar in Research Ethics

Comment: Recusal without “conflict of interest”

By Stephen Latham, Deputy Director

Comment: Bias vs. bias

By Ruth Ison, Research Compliance Auditor, Thomas Jefferson University

Case 3: The ability of a biomedical IRB to effectively manage socio-behavioral research

Comment: Diversity and the need for mentoring

By Lois S. Sadler, Assistant Dean for Academic Affairs, Yale School of Nursing

Comment: Controls on novice researchers

By Clair Kaplan, Associate Professor, Yale School of Nursing

Comment: Don’t be afraid to ask for help

By Sandra L. Alfano, Chair, Human Investigation Committee I and III, Yale University

Case 4: Public health practice vs. research

Comment: Lines unclear, community key

By Bruce Jennings, Director, Center for Humans and Nature

Comment: Is a new context coming? Who benefits?

By Lauren Taylor, Program Manager, Yale Global Health Leadership Institute

Comment: Is it research or practice?

By Julius Landwirth, Associate Director

Case 5: Reasonable right to privacy for patients accessing hospital services

Comment: Due diligence and ‘practicability’

By Chalmers C. Clark, Donaghue Visiting Scholar 2003-2004

Comment: Process, privacy, and PR

By Stephen Latham, Deputy Director

Comment: This time, keep it private

By Susan Bouregy, HIPAA Privacy Officer, Human Research Protection Program, Yale University

Case 6: An ethnographic study of homeless adolescents

Comment:  Competence, sampling, and risk to subjects

By Robert Heimer, Professor of Epidemiology & Public Health, Yale School of Public Health

Comment: Protect the researcher, include more subjects

By Adam Schechter, IRB Systems and Compliance Coordinator, Yale University