Lauren Surden, MSW, CIP
I often get asked about the education and experience needed to be selected to serve on an Institutional Review Board (IRB). The fallback response is that I hold a Master’s degree in Social Work (MSW), however, my education and work experience is only part of what I bring to my seat at the IRB table. Understanding who makes up an IRB is important in understanding the ethical review process for clinical research.
Federal regulations provide the framework for the composition of an IRB. US regulations require that there are at least five members, at least one member is representing a scientific area, at least one member whose experience is in a non-scientific area, and at least one member who is not affiliated with the organization. The regulations also require that the membership of the IRB demonstrates diversity in race, gender, and cultural background, and that there is appropriate representation for certain vulnerable populations. Additionally, all members representing quorum at the meeting must have an equal vote. With this framework, the IRB’s administration selects membership with experience and expertise that match the research commonly reviewed by the Board.
My role on the Board fits the criteria of a scientific member, representing children, pregnant women, and cognitively impaired research participants. My education is in the fields of psychology and social work, and most of my prior employment is in oncology research, with both direct patient contact and behind-the-scenes medical records auditing. I have a unique perspective of the clinical research process based on my prior work experience. As a member of an IRB, it is the first time in my career that I have felt equal to my colleagues, despite the long lists of credentials next to their names.
The review of research by an IRB is complex, as it is based on federal regulations, local laws, and the IRB’s governing SOPs, woven together with an ethical review from diverse cultural perspectives. It is the absence of specific regulations defining cultural background and experience that makes each IRB unique. With an emphasis on diversity and inclusion, an IRB strives to represent all populations that the research may encompass. A healthy IRB, led by a Chair serving to guide deliberations, will promote discussions of the scientific value of the research, the study design, safety, the informed consent process, the recruitment process, and the safeguards in place for study participants. Diverse enrollment populations stipulate different requirements for research sites. As an IRB, we draw on the experience and expertise of members to share concerns not only based on regulations, but their individual perspectives representing the subject population of the study.
While the discussion of race, religion, gender identity and other diversities have typically been seen as faux pas in the workplace, it is just the opposite at the IRB table. From the safety of my seat, I share opinions from the perspective of a heterosexual cis-female, white, progressive, Jewish Northerner (now living in the South), aware that all of these defining characteristics are as important and insightful as my prior experiences in clinical research. My role on an IRB has provided me at times a soapbox to voice my point of view, but more importantly, it has given me an awareness that my work impacts human health and promotes positive changes in society.