6
Dec2012

by Royell Sullivan, Institutional Review Board (IRB) Education Specialist at the New York University (NYU) School of Medicine

While sitting in IRB 301: Overview of the Criteria for Approval of Research on Monday, an issue arose regarding institutional review board (IRB) setup. Some IRBs assign primary and/or secondary reviewers to each protocol, while others do not. A debate ensued over whether the assignment of primary and/or secondary reviewers discourages the remaining board members from reviewing each protocol in its entirety.

One attendee brought up the point that the Office of Human Research Protections (OHRP) allows for primary and secondary reviewers and does not stipulate that every voting member present at the meeting must review each protocol.

Another attendee spoke of how dense biomedical protocols can be, and claimed that it is unreasonable to expect board members to read each protocol from start to finish.
Jeffrey A. Cooper, MD, MMM, IRB 301 faculty, begs to differ. He questioned the value of holding a convened meeting if the voting members neglect to review each protocol. The primary and secondary reviewers should be responsible for reading the submission entirely, while other reviewers should be exempt from reading the grant or investigator brochure, but not the protocol itself.
I found this topic interesting. I have been present during convened meetings that involve primary and/or secondary reviewers, and have noticed that the discussion of such protocols does not typically involve everyone sitting around the table. The primary and secondary reviewers usually lead the discussion, and maybe two or three other board members offer input. Everyone present votes. I questioned whether those who vote trust in the review capabilities of the primary and/or secondary reviewers, or if they review the protocol themselves.

I also questioned how thorough processes that do not involve assigned primary and secondary reviewers are. One could imagine that plenty of criteria may be overlooked. Who really knows?

Many protocols are filled with information that pertains to the study, but isn't necessarily important to the IRB. An attendee suggested the application requires the investigator to provide the IRB with the location of each section that reflects relevant criteria so board members can easily find what they are looking for. Dr. Cooper also suggested that investigators include an index for the same purpose. He noted that while this is helpful for the IRB, it may burden investigators. I feel the burden is worth it; it can reduce inconsistency and provide the IRB with information that they would need to ask investigators anyway if the protocol is deferred.

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