FDA Issues Draft Guidance for IRBs Conducting Continuing Review
The U.S. Food and Drug Administration (FDA) recently released draft guidance for institutional review board (IRB) continuing review—the first updates that the regulatory agency has provided for this process since it issued IRB regulations in 1981.
FDA’s original 1981 regulations were focused on single-site studies—the industry norm at the time—but, in recent years, multi-site studies have become standard and therefore require more oversight , according to the FDA.
The FDA requires IRB’s to review previously approved research at least once a year. In single-site studies, the continuing review obligation is fulfilled by the study’s investigator. However, with multi-site studies, the FDA explained, continuing review is more challenging because the IRB and investigator may not be as well informed about all the study data across all study sites. For these studies, IRBs may use cooperative review agreements or a centralized IRB review process to eliminate duplication of efforts and improve the review process.
The new guidance recommends that IRBs obtain continuing review information from study sponsors for multi-site trials. Sponsors are already required to provide annual reports to FDA about the progress of their studies, so they should already have the information that an IRB will need to conduct its review.
The draft guidance also includes recommendations for expedited review and how continuing review dates should be determined.
While the FDA calls the revised recommendations “substantial,” some experts in the field said it won’t change the way IRBs conduct business.
“The impact to our business would be nominal because the things that the FDA has highlighted we’re doing already,” said Felix Gyi, founder and CEO of Chesapeake IRB in Columbia, Md. “Where I think this is going to be most impactful is on the sponsor’s side because I think now many IRBs that had not been doing this or had not been following the open line of communication with the sponsor, it’s going to reach back to the sponsor. I think some of the workload burden is going to be shifted back to sponsors to provide that information, which is how it always should have been because the sponsors held the bulk of the information as well as the analysis of how the IRB needs to make certain decisions.”
The new guidance is in line with other existing guidelines for continuing review, like the recently released Department of Health and Human Services Office for Human Research Protections guidance, Gyi said.
The FDA will be accepting comments on the guidance through the beginning of March.