IRB Expertise

One of the major criticisms of IRBs that are raised by unhappy with IRB review is the expertise of the IRB. IRB expertise is a crucial element in effective IRB review of research. The regulations, at §46.107(a) state: "Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas." Therefore, an IRB that reviews a research study without the necessary expertise is not in compliance with the regulations. If it does not have that expertise on its membership, then it must use consultants to advice it.

The reason that the regulations, and best practice, requires appropriate expertise is that one cannot evaluate the risk in a research project unless one has expertise in that research area. The reviewers need to know the scientific background of the research and be knowledgeable about common practice and experience in the field.

When I was at the medical college, the IRB, which was primarily made up of health care professionals, received a qualitative, social science project to review. The IRB promptly disapproved it because it wasn't "science" in the view of the IRB members. I told them that they didn't have the necessary expertise to even review the project and had the research sent out to consultants with expertise in qualitative research. The IRB, after taking into account the reviews by the consultants, ultimately approved the project. This is an appropriate action by an Institutional Official. I did not overrule the decision by the IRB, but I made sure that the research was approved appropriately.

The same thing can happen when a social/behavioral IRB is made up of quantitative researchers, such as psychologists and sociologist and reviews an anthropology or oral history study.

It is the responsibility of the Chair and the IRB staff to determine whether the reviewers have the necessary expertise to review the research. If not, then they have to call on consultants to assist in the review. Researchers have the right under the regulations to have their research reviewed with the appropriate expertise and it is the Institutional Official's responsibility to ensure that the review is appropriate to the research.

Some IRB critics say that research should only be reviewed by people from the same field or let "ethnographers review ethnographers and experimental psychologists review experimental psychologists", as Zach Schrag has said. So, what's wrong with that? First of all, as noted above, the regulations require IRB members "with varying backgrounds". In addition, at §46.107(b), the regulations state "No IRB may consist entirely of members of one profession." Why? Because when IRBs are homogeneous they can become "blinded by the science". I have seen this happen many times on IRBs. The scientific members are focusing on the importance of the research and then a member from outside the field says, "Why is that so important? What about the impact on the subjects?". At that point, they other members say, "Oh, yeah. We forgot about that." Diversity of opinion helps ensure that all of the aspects of the research is taken into account.

Also, one aspect of human nature is that the more familiar we are about something, the more likely we are to underestimate the risks involved. It is very important to have input from people with diverse backgrounds to evaluate risk in research.

The strength of the IRB process is that it is a group decision-making process. I strongly believe that when a diverse group of people who understand the issues can come to a consensus, that is a close to a truly objective decision as is possible. After almost 30 years working with many IRBs, I have great faith in the system.