Scientists are often baffled that IRBs, whose members are usually respected colleagues, can be so unreasonable. This unreason is not only baffling, but can be infuriating, since the result is lost time and energy at the least, and the loss of entire grants and promising avenues of research at the worst. And, for the public, suffering and loss of life with the unjustified delay of new treatments.
The explanation is simple. As originally envisioned, the IRB is a committee that is asked to review research protocols and make reasonable judgments about whether or not they should be permitted to proceed and under what conditions. In their early days, this is just what they did, and the system worked tolerably well. Back then (we’re talking the 1960s and 1970s) the entire IRB apparatus consisted of a chair, the committee members, and perhaps a part-time staffer to handle the paperwork.
Over time, the paperwork requirements grew. Committees sometimes struggled to keep up. And then in 1998 the federal authorities at Office for Human Research Protections (the forerunner to today’s Office for Human Research Protections) began a major series of attacks on IRBs that thought they were doing a pretty good job. This period, called the death penalty era by those who were involved, made it clear to every research institution that the continued flow of federal funds depended on their IRB conforming in every imaginable respect to every requirement of the regulations and of the whims of the federal agency that administered them.
This is the kind of challenge that the original IRB was unprepared to meet. Neither the chair nor the members were trained to read the regulations and make sure that they were met, nor did they have the time to do so. And so institutional administrators took the original IRB and bolted on a support apparatus intended to make very sure that every regulatory requirement was met and every federal preference, as best it could be ascertained, was humored.
This work was not easy, but over time a workable solution was identified. One part was to ensure, usually by requiring scientists to submit their protocols through commercial software, that every box was checked. The system also required human management, by people who were hired to make sure that the IRB itself (remember those committee members?) could not get the institution into trouble. These people were sufficient in number and influence that they created their own advocacy organization, PRIM&R, which pushes for increased professionalization (and better pay) for its members.
It would be awkward for these staffers, however sure they are in their beliefs, to tell the chair that a proposal the committee has just approved is defective in some important way. Instead, the system is usually set up to conduct such a careful pre-screening that every protocol that makes it to the committee could be approved as is. So for an IRB member who wonders, “where are the ethically dubious protocols that we’re supposed to be guarding against?” the answer is that, if they ever existed at all, they’ve been weeded out by the staff before the committee even sees them. If you want to learn more about how this divided committee, with the staff doing the grunt work while the committee members deliberate the finer points that make it onto their agenda, Sarah Babb provides an excellent description in Regulating Human Research: IRBs from Peer Review to
Compliance Bureaucracy (Stanford, California: Stanford University
Press, 2020).
This is today’s divided IRB. On the one hand, the members, often respected scholars who are doing their best to make reasonable decisions in a system that thrives on unreason. IRB members are not saints, of course, but the great majority do what they can to help the system function well.
On the other hand, we have the staffers, who are paid not to use their common sense but rather to make sure that every regulatory angle has been considered and fully satisfied. Every proposal undergoes their scrutiny first, and only after they have signed off will the proposal be presented to the committee for its official review.
This is one reason why so many committee members hate it when their fellow scientists, knowing that they are on the IRB, ask if there is an explanation for the committee’s latest mysterious decision. The member usually knows nothing about the decision, since it was made by a staffer. If they do know the reason, it is often simply that the regulations require it. Or that the staff believe that the regulations require it, even when there is not actually anything relevant in the regulations at all. In a divided IRB, it is normal for the committee members to understand very little about how the staff provide “support.”
And this is why I believe that IRB committee members are the soul of human subject protection and that we will always need their contributions. They are doing their best in a very dysfunctional system. If we had a better system, with federal oversight that recognized that research sometimes save lives and that that matters, then they would remain the people entrusted with the final decision about specific protocols. We need them. We just don’t need the dysfunctional system that has been created around them.
April 12, 2023