Study: Are IRBs discussing the Common Rule? Report from AAHRPP Conference

January 12th, 2015

A study presented today at the AAHRPP conference in Miami suggests that IRB members may not be discussing Common Rule requirements as they should.

The study was performed by Paul S. Appelbaum, MD, and colleagues at Columbia University. The researchers observed 10 IRBs around the country by recording meetings and performing interviews with 263 IRB members. In 20 different meetings the researchers attended, 114 protocols were reviewed. After poring over hours of transcribed interviews and meeting, the researchers found that IRBs frequently failed to discuss many of the human subjects protection criteria mandated by the Common Rule:

--Equitable recruitment of research subjects was not discussed 80% of the time, and most discussions involved exclusion of pregnant women.

--Vulnerable populations were not discussed 50% of the time

--Safety monitoring was not discussed 73% of the time

--Risk minimization left out 37% of the time

“These data imply significant issues with not discussing required CR issues and perhaps excessive focus on consent issues – those were spoken of the most,” Appelbaum said to the audience. Indeed, the results show that informed consent was left out of discussion merely 2% of the time.

Of course – and as the audience full of members of AAHRPP-accredited IRB members were quick to point out – there are limitations to the study. A mere 10 IRBs were studied. There is no consideration given to why the issues were not discussed in meetings. And much work is done in the pre-meeting stages. Appelbaum conceded that the study data do not capture the work that is done in preparation for meetings. “But what these data do capture are aspects of what goes on inside the room and how it might differ from the regulatory or administrative vision of what should be going on,” he said.

Appelbaum also reported high numbers among the interviewed IRBs – usually around 15, with one study reporting a high of 44 members. Federal regulations only require five. “IRBs are filling the rooms of meetings with many more people than are required. This may be a good thing, it may not be a good thing… There may be too many people around the table.”

What are your thoughts? Are your IRBs discussing the necessary issues? Are you overstaffed – or even understaffed?