An institutional review board (IRB) plays a central role at any research university. The Helsinki Declaration mandates that an ethics committee approve research proposals before a study begins. Anyone with an elementary knowledge of research methods is probably familiar with the Nazi human experimentation in World War II or the Tuskegee syphilis study as classic examples of human research violations. Thus, there is clearly a need for ethical oversight.
However, what happens when an IRB becomes overzealous or overprotective? Who oversees the overseers? Can an overzealous IRB stifle research at will? Do they have unbridled authority? At most universities, it certainly seems like it. In fact, according to the Office for Human Research Protections, a division of the U.S. Department of Health and Human Services, institutional “officials may not approve the research if it has not been approved by an IRB.”
That is quite a bit of unchecked power. That leads to the question, what are the ramifications of an überprotective human ethics committee?
A dogmatically conservative IRB is analogous to someone driving 40 miles per hour on a freeway with a 75-miles-per-hour speed limit. The excessively slow driver thinks they are being super-safe, oblivious that havoc is occurring all around as other cars slam on the brakes or swerve abruptly into other lanes to avoid that overly cautious driver. Similarly, an extremely protective IRB that puts the kibosh on low-risk research proposals actually does more harm than good. Its actions can have damaging consequences for potential research participants, students learning research skills, researchers, academic programs and the university in general.
Understandably, COVID resulted in the stoppage of in-person data collection for some time at most research institutions around the world. IRBs were concerned about participant safety with regard to getting the coronavirus, and rightfully so. As people learned more about the virus and COVID safety procedures were put in place, resumption of data collection became a possibility. Consequently, many research labs, including those in my field of exercise physiology, began resuming collection activities in fall 2020 and early 2021.
I, like many researchers, requested a resumption of in-person data collection of a previously approved study that was halted in March 2020 due to the virus. For this particular study, the research participants were student athletes, and the study involved a short but intense bout of exercise. The IRB denied my resumption request.
At my appeal, I highlighted the fact that university-approved COVID safety procedures were in place in the lab: exercise equipment would be disinfected after each use. Participants would be tested individually; thus, only the participant and researcher would be in the 1,120-square-foot lab space for the 15-minute session. My participant population -- student athletes -- had been competing and/or practicing for the past seven months, often in large groups and for several hours per day. Further, student athletes are frequently tested for COVID at my institution, and many had already had the virus, thereby offering additional immunity. In short, they would be at less risk from participating in my study than they would be from their university-approved daily training and/or competitions.
Nope -- still denied due to unacceptable COVID risk. Previously infected and recovered athletes were approved by a physician to resume practice/competition, yet an IRB -- with no physician on the panel -- made the decision that the health risk was too great to resume an exercise data collection in a laboratory adhering to COVID safety procedures.
Why does it matter if an IRB is overprotective? No one is harmed if the IRB rejects a research proposal, right? Actually, many of the participants that the IRB claims they are protecting lose out on knowledge and personal data that may be useful to them when an IRB shuts down a study. In my world as an exercise physiologist, a research study may involve everything from a maximal aerobic capacity test (VO2 max) on a highly trained athlete to a bone mineral density scan of a postmenopausal woman. These tests are expensive, and many study participants are grateful for the chance to get such tests done free. They want to be in the study because they want to know their personal results. If an IRB denies a study, the associated benefits to potential participants are lost.
It would behoove the IRB to remember that one of the main precepts of research is voluntary consent. Let that play out. Give the participant the opportunity to make a decision. If potential participants are not comfortable with the safety protocols or the risk-benefit ratio in a research study, they simply will not volunteer to participate. Further, research participants always have the option to drop out or withdraw from a study after beginning it.
Overzealous IRBs also negatively affect students and researchers in training. Students enter an M.S. or Ph.D. degree program with the assumption -- and promise from the university -- that such a degree plan will involve research. In fact, that is the very reason some students gravitate toward this type of academic work as opposed to a clinical or nonresearch career path. An overly cautious IRB that slams the brakes on research proposals that involve even small risk greatly limits the ability of students to get the research experience they were promised. That could put these students at a great disadvantage for further study, postdoc positions or future research careers. Similarly, tenure-track junior faculty can have their chance for tenure and future career derailed if they cannot get their research proposals past an inordinately fearful or conservative IRB.
The IRB should remember that researchers are not out to injure or hurt their participants. That’s bad for business. Aside from ethics, it is challenging to get a research manuscript published if a lot of attrition is present in the study. Therefore, most researchers go to great lengths to minimize the risks in their studies, and the IRB should keep that in mind.
Finally, overly restrictive IRBs can damage academic programs and universities. It does not matter how well equipped laboratories are or how attractive the facility is if the IRB does not allow research to occur. Productive researchers at the university will simply stop banging their heads against the IRB brick wall and will reduce their IRB submissions or leave the university for a more amenable research environment. Once word gets out it is difficult to get routine research proposals through an IRB, the institution’s ability to recruit and retain quality graduate students and research faculty will diminish. Subsequently, grant money follows quality research and quality researchers.
Thus, an overzealous IRB can take down an entire academic program and weaken the research reputation of a university. Can we even call it a research institution if the IRB is blocking research from taking place?
IRBs are tasked with protecting the well-being of research participants. No doubt, they are acutely aware of the liability risks more than ever in the age of COVID. But überprotective IRBs smother investigation and discovery -- the very reason why research universities exist. An IRB that cancels everything out of fear deprives the participants that they are charged to protect from receiving meaningful tests, robs valuable educational experiences from student researchers, hinders the advancement of junior faculty, destroys research programs and hurts the reputation of the university. Just like a slow driver in the fast lane placing other drivers in peril, overprotective IRBs place everyone affiliated with research -- participants, students, researchers and programs -- in jeopardy.
Inside Higher Ed reached out to Utah State University, which had the following comment:
“An Institutional Review Board’s primary role is to ensure the protection of human research participants -- a role that was made exceptionally complicated by the onset of a global pandemic. During spring 2021, while local transmission rates were high and vaccination rates were low, the Utah State University IRB prioritized the resumption of in-person research that carried a prospect of direct benefit to participants, as well as those projects which presented very low risk for the transmission of COVID-19. USU is grateful to the faculty, staff, and community members serving on the IRB who were tasked with making difficult decisions regarding participant safety during uncertain times.”