July 5, 2022

Who is watching the IRB watchdogs, asks Nature

A stinging editorial in Nature claims that for-profit institutional review boards need careful supervision to ensure that they are following protocols and protecting patients.

A stinging editorial in Nature claims that for-profit institutional review boards need careful supervision to ensure that they are following protocols and protecting patients. It was prompted by a recent warning letter sent to the  Essex Institutional Review Board, an IRB based in New Jersey. According to the US Food and Drug Administration, Essex reviewed a fictitious clinical trial submitted by FDA investigators and approved it. However, it neglected to put appropriate warnings in the informed consent form and failed to notice that that the trial sponsor and the lead investigator were fictitious. It was not the first time that Essex had received a warning.

The Department of Health and Human Services is currently studying ways to streamline the burdensome paperwork involved in doing research on human subjects. Informed consent is required not only from patients in psychology experiments and drug trials, but also in oral history projects and journalism research. One proposed change would allow a single institutional review board to approve studies conducted at multiple sites. This would help researchers from several collaborating universities to get a single approval rather than several different and possibly conflicting responses from IRBs.

Nature has rung a warning bell:

“IRBs at academic institutions have their own ulterior motives to approve trials — among them institutional profile and prestige. And they, too, make mistakes. But the dollar remains the most powerful incentive to cut corners. The volunteers on whom clinical trials depend deserve the highest possible protection. Before implementing change that could see private companies overseeing an increased number of multi-site trials, the government should ensure that scrutiny of these IRBs is expanded to match.” ~ Nature, Aug 11

Michael Cook