Do we need IRBs for IRBs? And should they be for-profit?

“These are black boxes,” said Dr. Steven Joffe, a pediatric oncologist and bioethicist of the University of Pennsylvania, who serves on the FDA’s Pediatric Ethics Committee. “IRBs as a rule are incredibly difficult to study. Their processes are opaque, they don’t publicize what they do. There is no public record of their decision or deliberations, they don’t, as a rule, invite scrutiny or allow themselves to be observed. They ought to be accountable for the work they do.”

That is part of a longer and very interesting article on whether IRBs should be for-profit, or if we even at this point have a choice:

“This shift to commercial IRBs is, in effect, over,” said Caplan, who heads the division of bioethics at New York University Langone Medical Center. “It’s automatic and it’s not going back.”

Institutional review boards — which review all research that involves human participants — have undergone a quiet revolution in recent years, with many drug companies strongly encouraging researchers to use commercial boards, considered by many more efficient than their nonprofit counterparts.

Commercial IRBs now oversee an estimated 70 percent of US clinical trials for drugs and medical devices. The industry has also consolidated, with larger IRBs buying smaller ones, and even private equity firms coming along and buying the companies. Arsenal Capital Partners, for example, now owns WIRB-Copernicus Group.

But even if the tide has already turned, the debate over commercial review boards — and whether they can serve as human subject safety nets, responsible for protecting the hundreds of thousands of people who enroll in clinical trials each year — continues to swirl.

I am not well-informed in this area, but if you refer back to the first paragraph, perhaps nobody is.  That’s worrying.

For the pointer I thank Michelle Dawson.


Comments for this post are closed