Demystifying the Institutional Review Board
SAEM PULSE | MAY-JUNE 2022
By Adrienne Malik, MD; James Paxton, MD, MBA; and Mark Mycyk, MD on behalf of the SAEM Research Committee
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From the outside, it may appear that the Institutional Review Board (IRB) is a group of maleficent specters intent upon derailing the well-intentioned efforts of researchers who are simply in pursuit of undiscovered truths needed to improve the practice of medicine. But those on the inside understand that the IRB exists to protect human subjects from abuses that may be completely incomprehensible to most researchers. As members of the IRB Illuminati, we bring you information from “behind the curtain,” to help you better understand the process, its invaluable function, and some tips on how to tailor your submissions to make them more acceptable to your IRB colleagues. We promise, we are on your side.
Why do we need an IRB?
All institutions engaged in research are required to have an IRB and they all function similarly. The purpose of the IRB is to assure that, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of human subjects participating in research. The over-arching focus of this group is on the risk-to-benefit ratio for subjects engaged in research.
Regulation from the IRB is needed to prevent citizens from engaging in clinical research that poses an unacceptable risk to their health without adequate benefit to themselves and society. IRBs exist because in the past some very questionable (and at times abhorrent) methods have been employed in the name of research, at the very real and unethical expense of study subjects (e.g., The Tuskegee Study). In short, the IRB exists for the benefit and protection of potential study subjects.
Who are the members of the IRB?
United States Food and Drug Administration regulations [21 CFR 56.107(a)] require that the IRB must have a "diversity of members, including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes." Consequently, membership in the IRB includes a mix of community members as well as research scientists and other individuals with insight into the research process. In general, IRBs cannot decide on research protocols without adequate representation by “laypersons” from the community. It is important to remember
that IRB members are volunteers, with a wide range of backgrounds, including physicians, nurses, pharmacists, lawyers, business leaders, and other members of the community. By law, IRBs must contain at least one non-scientist and one individual not associated with your institution to act as unbiased stakeholders on the behalf of study subjects.
What are the types of IRB submissions?
Submissions to the IRB can be categorized as “exempt” (not requiring IRB oversight), “expedited” (not requiring full committee review) or requiring “full board” review. Although the IRB may offer decision tools to help researchers assess the distinction between these types of submissions, the final determination remains up to the IRB. Expedited submissions are generally low-risk protocols that may be reviewed by a single appointed IRB member, rather than the full IRB. Once an expedited or full-board protocol has been approved, the study team may submit an “amendment” (aka “modification”) to change any aspect of the study, or a “continuation” to
