Research Ethics Boards/IRBs May Have Gaps in Expertise

By Stacey Kusterbeck

Research ethics boards generally have sufficient expertise to review most types of studies but may need to recruit new members or use outside consultants for fields with increased complexity or emerging areas, according to a recent study.¹ Institutional review boards (IRBs) are addressing this in a number of ways.

“We revisit our roster annually. In addition, we are always looking for opportunities to fill any gaps we may have during the course of our operations,” says Jill Opalesky, MS, ATR-BC, ATCS, CCRP, Human Research Protection Program director at Virginia Commonwealth University. Opalesky says these are the biggest gaps she sees on IRBs in terms of expertise:

• representation of a research subject or community member;
• prisoner representation (someone who has been in prison but now is an active community member);
• cultural competence (having representation from the communities involved in research).

“IRBs would benefit from these folks being part of the panel, but they are hard to find, train, and maintain. They would bring a great deal to discussions and protections of our research participants,” says Opalesky.

Ideally, IRBs evaluate adding new members on an ongoing basis. “The training and onboarding of new members is done annually. It is a rigorous process, it takes commitment,” says Opalesky.

Every research ethics board occasionally comes across a study, at one time or another, that requires specialized expertise that is lacking among their members. “We do have consultants that can be used in novel cases or unique situations,” says Opalesky.

The regulations under which IRBs operate (the Common Rule and Food and Drug Administration [FDA] regulations) stress the fact that IRBs should be made up of a group of members with adequate scientific expertise to allow them to do what they are supposed to do, says Bruce Gordon, MD, assistant vice-chancellor for regulatory affairs and executive chairman of IRBs at University of Nebraska Medical Center. However, having members with expertise on every conceivable topic the IRB may be asked to review is not feasible. “From a practical point of view, you’ll end up with a board that is made of 147 members,” says Gordon.

IRBs should not all be the same — but should be appropriate for the institution. The University of Nebraska Medical Center’s five IRBs have between 10 and 25 members each, and lots of alternates. Other IRBs might have as few as five or eight members. “The composition of the IRB should reflect the type of research being done at the institution at any given time. If you see a lot of oncology protocols, you probably need an oncologist on the board,” says Gordon.

One model is for IRBs to draw on a very large group of members who are asked to review certain study protocols based on their specific area of expertise. “Some IRBs are constructed that way. They create the individual board on the fly, based on what they’re reviewing,” says Gordon. Another model is to have a smaller IRB, but to use consultants as needed. “The regulations are quite clear that we are allowed to bring in people with particular expertise in particular subject matter. They don’t vote, but they are there to provide information to the board,” says Gordon.

When conducting site visits for accrediting agencies, Gordon asks the IRB members how they would review a pediatric neuro-ophthalmology trial (as an example of a rare and very specific medical specialty), if they do not have a pediatric neuro-ophthalmologist on the board. “The answer we want to hear is to bring in a consultant. But sometimes that’s more difficult than it appears,” says Gordon.

There may be only one pediatric neuro-ophthalmologist in the community. IRBs are supposed to be resourceful and look outside of the community to obtain needed expertise. “If we can’t find a consultant in the community, we personally would look for one outside of the community. Where it becomes a problem is with IRBs that are small and don’t have a lot of experience. An IRB that meets once a month and reviews only 10 protocols a year might not have the infrastructure to know who to consult about something,” says Gordon.

Often, it is not really necessary for IRBs to consult with an expert on a particular topic. “This is not a closed book test,” says Gordon. IRB members can review the study protocols in advance of the meeting and can go to the literature to research any necessary information. Generally speaking, the specifics of a given study are less important than the review process, which is the same regardless of the type of study, says Gordon.

Gordon gives the example of research done on the Ebola epidemic in Western Africa or during the global pandemic. Initially, the IRB was concerned that a new process was needed to do emergency research in those settings. The IRB developed what it called a rapid response IRB. “But we realized that the review was not fundamentally different from a review of research in an ICU [intensive care unit] or research with a critically ill patient. The fact that the research is done during a global pandemic doesn’t change the fundamental review strategy,” says Gordon.

The IRB process is the same regardless of the type of study: to ensure that core ethical principles are being maintained, that the regulatory criteria are satisfied, and that the risks are minimized and reasonable compared with anticipated benefits. Study protocols have background sections to explain why the study is scientifically valid, why it is appropriate, and why the risks are justified by the anticipated benefits. “A common reason why we send the protocol back and table or defer it is because the researchers don’t give us enough background information. We want them to explain to us why the study justifies the potential harm to subjects,” says Gordon.

IRBs need members who understand this concept and can determine if the study is constructed in a way that will lead to generalized knowledge that will help society. “If not, then however trivial the risks are, they are unacceptable,” says Gordon.

It is not possible for researchers to know all of the possible risks involved in any study. “You test it in a lab and test it in animals and test it in healthy people and now you are taking it to sick people. There are always unknown risks, so you want it built into the protocol to catch them early enough. You want the consent to reflect the fact that these are the risks that we know about, but there may be other risks,” says Gordon.

When a new technology comes out, whether it is artificial intelligence, whole genome sequencing, or xenotransplantation, IRBs are more conservative because they do not yet understand the risks. For such studies, IRBs are likely to want more precautions in place (such as additional monitoring), so researchers will be ready to act if there are any unexpected issues. After IRBs are more comfortable with a given technology, it may become apparent that the extra precautions are unnecessary and stand in the way of providing potential benefit.

“IRBs do not have to be experts in absolutely everything. We are experts in the core ethical principles. For everything else, you can bring in a consultant who explains to you why a scientific approach makes sense,” says Gordon.

Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.

Reference

1. Tumilty E, Young J, James R, et al. A scoping review of empirical research on research ethics board membership and expertise. J Empir Res Hum Res Ethics. 2025;20(5):275-285.