OHRP director explains shift on central IRBs

'Use of a central IRB can be a very good thing'

The Office for Human Research Protections (OHRP) in Washington, DC, is indicating to research institutions that the agency favors the use of centralized IRBs for multisite studies. Recently, the agency published a letter it had written to a North Carolina hospital system about the use of central IRBs. IRB Advisor asked OHRP Director Jerry A. Menikoff, MD, JD, about this change. Some of his answer is contained in this "Ask2-4U" below:

IRB Advisor: Who is responsible if an external IRB has a noncompliance issue when reviewing a research site's study?

Menikoff: The bottom line is that if something inappropriate happens in the study due to an outside IRB, whether it's a central or some other IRB doing something wrong, and we take a compliance action related to that, we will certainly make it clear in our findings that the fault was due to the IRB and not to the people in the institution. It's a question of making it as clear as possible so everybody understands who really was at fault.

In that one example of the letter to the University of Oklahoma, there was one NCI [National Cancer Institute] central IRB that reviewed the study, and Oklahoma was one of the sites. Oklahoma's IRB reviewed the study, and its IRB did not change some of the consent provisions that were approved by the central IRB. The complainant complained about some provisions of the consent form.

We made it clear that Oklahoma wasn't doing anything worse than the other 100 sites using the consent form, which was vetted by the central IRB. We think some of this is common sense. As far as liability goes, [it pertains to] whoever does something wrong.

IRB Advisor: Is there any other message about central IRBs that you'd like to send to research sites?

Menikoff: I don't know the message is any different than what the letter is trying to get out. That is why when we received this query [from Carolinas Medical Center in Charlotte, NC] we viewed it as a good opportunity to make our response public. We do very much think the use of a central IRB can be a very good thing. We do encourage their use, and I want to clarify on this issue there's a great deal of harmony between FDA's and OHRP's viewpoints. Both entities are very much in favor of this.