Protecting He-Man Subjects

After frustrating encounters with IRBs concerning two research projects, sociologists Liberty Walther Barnes and Christin L. Munsch argue that “IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men.”

[Liberty Walther Barnes and Christin L. Munsch, “The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards,” Feminist Studies 41, no. 3 (2015): 594–622, doi:10.15767/feministstudies.41.3.594.]

Minimal Risk Approval: 27 months, $170,000

A team of health services researchers found that getting approval for a minimal risk study took 27 months and consumed $170,000 in staff time.

[Laura A. Petersen, Kate Simpson, Richard SoRelle, Tracy Urech, and Supicha Sookanan Chitwood, "How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research," Annals of Internal Medicine 156, no. 10 (May 15, 2012): 728–735. h/t Human Subject News.]

Hospital IRB Forbids Interviews with Patients

The Yale Interdisciplinary Center for Bioethics offers an interview project as one of its Cases in Research Ethics, which describe choices faced by hospital IRBs in Connecticut.

Case 3 concerns a nurse who was also a divinity school student, and who gained approval from her hospital's IRB to interview fifteen "hospital patients who were suffering from a progressive and/or life-threatening disease such as cancer" about their religious beliefs and practices and the role of religion in their feelings about their illnesses. Patients agreed to participate after "a thorough review of the purpose of the study, the nature of the questions and the time involved for participation."

Eleven interviews went fine. Then the twelfth patient "became agitated and demanded the researcher leave immediately. The researcher spoke with the hospital nurses and was informed that this subject had 'fallen away' from her prior religious involvement and had wondered if her malignancy was divine retribution for her lapse."

The researcher dutifully reported this as an adverse event. The IRB then reconsidered the project and voted 10 to 1 to forbid the researcher from interviewing the three additional patients.

As described in the case study, the IRB recognized that, collectively, it knew little about this kind of research. "While this IRB was routinely accustomed to addressing the standard types of adverse medical events seen in oncology drug trials, it did not consider the possibly significant adverse psychological consequences of asking these same subjects about their religious and spiritual beliefs vis-à-vis their disease."

Yet the IRB's awareness of its ignorance did not prevent it from stopping the research project. The case study does not give the reason for this decision.