Appeals

At a recent seminar held CUNY on IRBs and social/behavioral research, the question of an appeal process for IRB review was raised. This is an issue that has repeatedly been brought up as a criticism of the IRB process and I thought I’d address it.

First of all, the provision in the regulations that states, “…officials [of an institution] may not approve the research if it has not been approved by an IRB” [46.112] is there to minimize the influence of institutional conflicts of interest. If Dr. Smith, who has a multi-million dollar grant, complained to the President of the institution about an IRB decision and the President could overrule the IRB, then the protection of the subjects by the IRB process would be undermined. This decisional independence is essential for the IRB to fulfill its mission.That being said, IRBs are not autonomous entities unanswerable to anyone, as many critics claim. IRBs are agents of the institutions, which have the responsibility to ensure that the IRB process is not only in compliance with the regulations but also effective, efficient and appropriate to the research being reviewed. The FWA assigns that responsibility to the Institutional Official who signs the FWA.

So, while the institution cannot overrule negative decisions by the IRB, it can intervene if the process is inappropriate. This is similar to the US judicial system. The judicial appeal system does not rule on the outcome of trials, but on the process. You cannot appeal just because you disagree with the outcome of your trial, but you can appeal if you believe that you have been denied due process. Similarly, a researcher should not be able to appeal because he or she disagrees with the IRB’s decision. But, if he or she believes that the process was not fair, the decision was arbitrary or capricious, or did not have an appropriate ethical or regulatory basis, then the researcher has the right to appeal that to the Institutional Official. The IO should investigate the process and, if it is determined that the process was inappropriate, then the IRB should reconsider the decision.

In addition, the institution should oversee the IRB’s policies and procedures. The IRB should be responsible for explaining the basis for what it does and ensuring that its policies and procedures are appropriate for the research it reviews. How this is accomplished is up to the institution and depends on the culture and governance system at the institution. I strongly recommend that all institutions set up some sort of advisory committee for its HRPP. Again, this committee would not have any say over IRB decisions, but would have input on the IRB’s policies and procedures. The IRB should provide regular reports on its activities to this committee and the committee should review the HRPP policies and procedures. This would provide necessary transparency to the IRB review process and provide a voice for the concerns of the research community.

The perception that the IRB is not answerable to anyone undermines the research community’s trust in the IRB review process and could lead to an adversarial relationship between the IRB and the research community. Such an adversarial relationship puts subjects at risk because it increases the likelihood that researchers are not forthcoming to the IRB and that research is conducted without IRB approval.