Cami Gearhart

by Cami Gearhart

Letter from the CEO

Even as the ethics review community awaits the next iterations of the NPRM and the Draft NIH Policy on the use of a single IRB, institutions are making arrangements to support centralized ethics review of multisite studies. The pressure to centralize review comes from all sides: the National Cancer Institute, the NeuroNEXT network, and an increasing number of industry sponsors require institutions to rely on a single IRB of record. All around the country, institutions are preparing to act as central IRBs themselves and outsource to other central IRBs.

We applaud these efforts. Relying on a single IRB of record in a multisite study is clearly of benefit to the study participants. As an independent IRB, Quorum Review IRB sometimes acts as the central IRB in a multisite study and, at other times, we act in the role of a local IRB.

The difference in our ability to take action on behalf of subjects is significant. When Quorum acts as a central IRB with jurisdiction over multiple sites, we are able to insist that the protocol be amended when we have participant safety concerns. This also enables us to require the sponsor, funding agency, or lead investigator to submit information to us and otherwise respond to our concerns.

In contrast, when Quorum acts as just one local IRB of many in a multisite study, we have little power to influence change in the overall protocol or study design. We often struggle to obtain information or responses to our concerns.

There are many elements to consider as institutions move toward the goal of centralizing IRB review. If and when it makes sense for your institution to outsource IRB review to an independent IRB, Quorum is committed to supporting you with a high-quality review and a strong regulatory team.

Additionally, our consulting division, Kinetiq, can assist whether you want to build functionality as a central IRB or need to revise your processes to support outsourcing to other institutions or IRBs.

We all can benefit from an open exchange of information about centralizing IRB review. As part of this information exchange, I invite you to attend the NWABR IRB conference—co-presented by Quorum—to be held on July 21 called “Ethics and Regulation in the Digital Age.” In an afternoon panel discussion, leaders from research institutions will discuss how they have prepared to act as a central IRB and outsource to other central IRBs. The conference will be held in Seattle, Washington; you can register to attend in person or virtually by webinar.

 

Tags: , ,