Applying Principles to Process: the Belmont Report and the work of the IRB

The Belmont Report serves as the ethical basis upon which regulations on the use of human subjects in research are based. These principles do not technically govern the research process, and yet are essential to ensure that research is done ethically. At the 2014 Advancing Ethical Research Conference, Gigi McMillan interviewed Ilene Wilets, PhD, CIP, executive director of the institutional review board (IRB) at the New York State Psychiatric Institute, for People and Perspectives. During her interview, Dr. Wilets explained, “you have to have the ethical underpinnings woven into the fabric of human subjects protections.”

In order to get a better understanding of how the Belmont Report is being applied to functioning IRBs, Ms. McMillan asked Dr. Wilets, “How do you see the principles of the Belmont Report being applied in the actual IRB process?”

Respect for Persons: The Belmont Report states, “Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.” In thinking about her own IRB office, Dr. Wilets spoke of developing a process that leads to valid, informed consent. Further, she also emphasized that we should not compare informed consent as it exists in research to other times when someone may consent to doing something – having Italian food for dinner, or going to a movie, for instance.

Beneficence: In terms of beneficence, the Belmont Report offers, “Two general rules have been formulated as complementary expressions of beneficent actions: (1) do not harm and (2) maximize possible benefits and minimize possible harms.” When considering risk/benefit, Dr. Wilets explained that, in her experience, IRBs are really becoming “brilliant at…looking at best ways to minimize the risk and correctly stating the possible benefit.” That being said, there are many different ways to think about risks, including cultural differences. One thing Dr. Wilets would like to see researchers consider in the future is that “not everyone thinks about risk [in the same way]…we need to find ways to really broaden how we discuss, conceptualize research risk.”

Justice: When considering justice, the Belmont Report asks “Who ought to receive the benefits of research and bear its burdens?” Dr. Wilets explained that she is most interested in distributive justice, where the “risks, benefits, and burdens of research make their way to all communities.” The advent of social media and other technologies has expanded access to research for some, but not everyone. There are individuals who aren’t connected—“You hear that a quarter of the world is on Facebook but [that leaves] three-quarters of the world not on Facebook”—and we should not forget them.

Hear more from Dr. Wilets, including how an IRB administrator facilitates interaction between all stakeholders in the review process, on the People and Perspectives website. Or, share your own thoughts about how the Belmont Report is being applied to processes used in your IRB in the comments below or by sharing your story on the People and Perspectives website.