Human Subjects Research Review: Basics of the I.R.B.


Human subjects research conducted by university agents typically requires oversight and approval by a human subjects review board or institutional review board (I.R.B.)…


The harm occasioned directly or indirectly by inhumane experiments in Nazi Germany, Rwanda, the United States, and elsewhere prompted the development of formalized human subjects research review. In the late 1940s, the Nuremberg Military Tribunals raised awareness of Nazi war crimes and issued The Nuremberg Code, which underscored the importance of voluntary consent. Domestically, that precept was developed by the National Research Act, 42 U.S.C. § 201 (1974) and The Belmont Report of the U.S. Department of Health and Human Services (1979). That report outlined best practices for minimizing harm to study participants. It articulated three core principles: Respect for persons, beneficence, and justice. Respect for persons honors human agency and the need to safeguard persons of “diminished autonomy” (e.g., prisoners). Beneficence requires that researchers strive to minimize physical and emotional harm to their participants while maximizing the amount of good from the study (e.g., by disseminating the results). Justice urges researchers not to target vulnerable subjects or fail to deliver advantages (e.g., new drug therapies) to those who need them, when possible. Together, these principles suggest that researchers ought to treat their subjects ethically, conduct their research rigorously, and allocate benefits and burdens as humanely as possible. These guidelines can be tricky to translate into practice.


The principles articulated in The Belmont Report do not always mesh with scientifically optimal research design. For instance, an incarceration study might be slightly more valid if conducted using prisoners in maximum security rather than minimum security prisons. But if empirical evidence suggested that the two populations were close comparisons and that the minimum security prisoners would face significantly fewer potential harms, an institutional review board (IRB) might urge a researcher to consider the more beneficent route. That recommendation might spark a productive dialogue between the researcher and the IRB. Institutional Review Boards have the potential to enhance or derail important research. At their best, IRBs engage in back and forth discussion––in the form of email and document exchanges––with researchers, also called primary investigators (PIs). The process provides PIs with peer feedback, and helps ensure that institutional agents are conducting principled research. The benefits of IRBs are aptly described in numerous health law textbooks, including Furrow et al.’s Health Law: Cases, Materials and Problems (2013). Furrow et al. describe the limitations of IRBs too, as did Joan E. Sieber, in her 2004 Ethics & Behavior article, “Empirical Research on Research Ethics.” Sieber explained that while IRBs have advanced important discussions about experimental research ethics, none have settled the normative questions raised by controversial post World War II experiments (e.g., the Stanford Prison Experiment). At their worst, IRBs censor important research studies in their formative stages, precluding potential benefits. This topic was the focus of a symposium and law review issue at Northwestern University Law School in 2006 and 2007, respectively. Research suppression was also explored at length in Laura Stark’s 2012 ethnography, Behind Closed Doors: IRBs and the Making of Ethical Research. Tabling the debate over IRB outcomes, it is important for newer empirical researchers to learn the IRB process so that they can navigate it effectively.


While the IRB process differs across institutions, my experience with IRBs at universities in Connecticut, New York, Ohio, and Texas suggests that typical practices deviate only slightly. Institutional Review Boards tend to meet regularly (e.g., monthly) from September to May, and sporadically in the summer. They require that researchers conducting risky research* submit completed applications one or more weeks prior to their scheduled meetings, often electronically. A quintessential full IRB board review protocol includes: cover page; topical introduction and literature review; research purpose, significance, and potential benefits; research methods; research instruments; sampling and participant selection protocols including recruiting documents; discussion of potential harms to participants; informed consent procedures and consent documents (e.g., debriefing scripts); data protection and/or management plans, including efforts to guard anonymity and confidentiality; researcher institutional affiliations; and completed Collaborative Institutional Training Initiative (CITI) or other research ethics training course certificates for all researchers. 

*Much of the research conducted by law school professors and students, including survey and interview research involving minimal risk to participants, meets the federal requirements for either exempt or expedited review (see 45 C.F.R. 46.101-110). Exempt review is often performed by a designated staff member; expedited review is conducted by one or more members of the I.R.B. Exempt review, in particular, entails a significantly shorter I.R.B. protocol. Before completing the lengthy protocol described above, researchers should familiarize themselves with local policies and forms. At Yale Law School, faculty and students can contact Michelle Hudson for guidance on whether their research falls into an exemption category. 


Institutional Review Board


Furrow et al., Health Law: Cases, Materials and Problems

Mamdani, When Victims Become Killers: Colonialism, Nativism, and the Genocide in Rwanda

Reverby, Examining Tuskegee: The Infamous Syphilis Study and Its Legacy

Stark, Behind Closed Doors: IRBs and the Making of Ethical Research

Washington, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present 

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