Tag Archives: Human Subjects

Amita Verma on Institutional Review Boards

Kaley Wilburn | Graduate student in the Biological and Biomedical Sciences program

On April 28 Amita Verma, the director of the Office of Research Integrity and Assurance at Cornell, visited ASAP’s regular meeting and asked us thought-provoking questions about the ethics of including human subjects as participants in research.

Amita opened the discussion by explaining the events that led the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to issue the Belmont Report in 1978. The Commission was directly motivated by problems that developed as a result of the unethical Tuskegee Syphilis Study, but historically other studies had also proven that serious potential for ethical wrongdoing was intrinsic to unguided research on human subjects. Thus, the Belmont Report laid out three core, guiding principles to better protect study participants: respect for persons, beneficence, and justice.

Throughout ASAP’s meeting, we discussed the multifaceted meaning of these principles and considered their necessity within all research studies, not just those including human participants. We also gained insight into the way institutional review boards (IRBs) apply these principles to ensure the research plans they approve stand on firm ethical ground.

In a case study, we played the role of a prominent doctor running a clinical trial for a new cancer drug. While we approached this somewhat corny role-playing activity lightheartedly, we also came to realize as a group just how difficult and complex it could be to make ethical choices despite our best intentions. It turned out that balancing the hope for novel treatments with the safety of patients, or weighing the desire for progress against the necessity for institutional approval, was almost never as easy as we wished it would be.

As a student who has spent most of my time in the lab working with bacteria rather than human subjects, I hadn’t honestly given questions of human subject research the thought they deserve before this meeting. However, I walked away from our discussion reminded of how remarkably universal these questions are and how important it is to ask ourselves to think about the principles we ought to stand by as scientists, long before we are challenged to apply them.