Many IRBs use an assigned reviewer system. Most typically, an assigned reviewer is a member of the IRB who is assigned to review a protocol and make a recommendation. Assigned reviewers can be assigned for full board protocols and in this capacity, they may work with the PI on changes prior to the convened meeting. They may also present the protocol at the meeting and present their criticisms or concerns prior to other members of the committee. It is important to note that while one or two members may be assigned specific protocols, all members of the committee have the obligation to review all protocols on the meeting agenda. It should also be noted that the IRB is free to ask individuals who are not members of the IRB to review protocols for which these individuals can provide unique scientific, clinical or area expertise.
When reviewers are assigned to expedited review protocols they may also provide feedback to investigators and can be charged to make the final expedited review approval, or they may communicate their findings to the IRB chair or coordinator who in turn communicates concerns to the PI and ultimately issues the approval. Some IRBs also assign reviewers to exempt protocols.
There are a wide variety of practices regarding assigned reviewers. In some cases, they are not identified to the PIs and they communicate their concerns to PIs through the IRB chair or coordinator. Other IRBs have the assigned reviewers communicate directly to the PI. It may be more difficult to maintain anonymity in this case, but electronic IRB systems can manage this if reviewers don’t directly self-identify in their communications. But there is no necessity that reviewers not be identified to the PIs. Many IRBs assign reviewers whose names are known to the PIs. There is no regulator language on this matter so it is up to the IRB to stipulate its own policies.
While assigned reviewers can help spread the work load around a committee and when they are assigned based on their area of expertise, they can provide deeper insight into risks and benefits, assigned reviewer systems can present some problems. First, assigned reviewers must be diligent in completing their reviews in an appropriate amount of time. PIs are obviously anxious to start their research as soon as possible. Assigning reviewers and giving them one or several weeks to complete their review slows down the review process. It is always important to select diligent and responsible IRB members for this task.
Second, as we all know from discussions in convened IRB meetings, different members of the committee will have different concerns and perspectives on the research. This can be a virtue when one or several reviewers bring to light import issues that will improve the protection of the subjects of the research. Indeed, with research that poses greater than minimal risk, the entire committee is called upon to review and weigh in with their opinions at a convened meeting. This diversity of perspective can improve scientific design, the transparency of consent forms and ensure maximal protection of the subjects of the research. On the other hand, this diversity of opinion, when exercised on minimal risk protocols (expedited or exempt research) can result in varying or even conflicting demands on investigators by different reviewers. As a result, many IRBs that use assigned reviewers for expedited and exempt protocols will often require the reviewers to communicate their concerns to the chair or IRB coordinator who can collate them and present a more unified set of requests for revisions.
A third hazard arises when reviewers focus on issues of scientific design in minimal or no risk research (exempt and expedited review protocols). While occasionally concerns over scientific design may lead to further protection of human subjects, these protocols are largely free of risk and the incremental improvements may not merit the additional time and attention of reviewers. These issues might be addressed just as easily by the IRB chair or coordinator.
The federal regulations do not specify that scientific design of protocols is a specific area of concern for the IRB. What the regulations do say, however, is that “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.” (45CFR46.111(2)). If risks to subjects are already minimal or non-existent, then they are by definition “reasonable” relative to the “importance of the knowledge” to be gained by the study. Obviously, we want good research to be performed and IRB members generally have expertise in scientific design. But IRBs are not charged with the task of improving science, only with the task of protecting human subjects. We should be wary of empowering reviewers to insist on changes in the design of studies when subjects are already at little to no risk.
I believe this problem can be exacerbated by assigning reviewers anonymously, since they can impose their own views on research design questions much more freely when they do not have to face the PI directly with their criticisms. The obvious reason for anonymity is to allow reviewers to present a frank assessment of the protocol without fear of hurting feelings or pressure from PIs or others with an interest in the protocol. On the other hand, I would point out that IRBs were originally conceived as “collegial peer review committees” by the National Commission. Over the years, IRBs have increasingly tended toward the “compliance” end of the spectrum. But a healthy, collegial environment within an institution can sustain identified reviewers and the give and take of criticism and debate is a normal part of professional work and the academic environment.
While a policy of anonymous reviewers may be a response to an institutional culture that may already be strained, the use of anonymity may actually make this culture worse by giving reviewers freedom to act without accountability. I don’t mean to imply that reviewers are not accountable to their IRBs but their comments, when anonymous, may require vetting by the chair or coordinator so as to “clean up and soften” the language as well as disentangle the human subjects protection issues over which the IRB has clear regulatory authority from the scientific design issues for which it only has derivative authority when subjects are placed at risk.
In conclusion, I would encourage IRBs to use an assigned reviewer system for full review protocols. Where you institutional culture supports it, I would recommend avoiding anonymous reviewers. For expedited review protocols, it will depend on the workload and the staffing of the IRB. One or two individuals can develop a much more consistent review practice and can generally operate on shorter turn-around times. Sending protocols out to one or several reviewers on a rotating basis may lessen the workload but at the cost of longer review times and less consistency across reviews. For exempt protocols, my recommendation would be for the chair or an IRB staff member to be assigned to handle these. The goal here is to determine exemption, not do a major review. We all may make recommendations on exempt protocols and when they come with consent forms, work to ensure that they have the proper form. But assigning IRB members to review exempt protocols is not the best use of their time and members are generally less likely to fully understand the application of the exemption categories.