Time to Nationalize IRBs?
Drawing upon Carl Elliott’s new book on “the dark side of medicine” and historian Susan Reverby’s stunning revelations concerning US researchers’ unethical experiments in Guatemala, Alice Dreger makes a proposal worth paying attention to: nationalize institutional review boards (IRBs). In her recent article in Bioethics Forum, Dreger begins with a story from her experiences as a faculty member at Northwestern:
[W]e faculty got an e-mail from one of our clinician-researchers looking for subjects for an industry-sponsored trial of an experimental surgery aimed at a non-elective medical need. I was disturbed to see what our IRB had approved; the set-up looked seriously coercive, with subjects having all expenses paid – to the tune of thousands upon thousands of dollars – if they would subject themselves to surgical experimentation to get their medical needs (hopefully) met. Mind you, a perfectly standard surgery exists for the problem in question, but you can’t get that paid for if you’re uninsured and not in dire poverty. Meanwhile, the experimental surgery sounded so bizarre that my internist husband assured me the e-mail solicitation was just an out-of-season April Fools’ joke.
No joke. And I tried talking to the researcher about it. He seemed like a genuinely concerned guy. But he was sure our IRB wouldn’t have approved a coercive study. Me, I was sure you don’t get to be as rich in industry funding as my school is by putting up lots of “roadblocks” to IRB approval.
Dreger is concerned that the current system for human subject protection is largely designed to prevent overt intentional wrongdoing without acknowledging the dynamics that can lead well-intentioned researchers astray. Or, as Dreger puts it: “It should practically be a standard set of directions on Google Maps: begin at good people, turn right while blinded by intense focus on one’s biomedical research, arrive at Hell. Rest assured, the road is well paved. Fully beta tested.”
Her solution is a “nationalized system of IRBs for biomedical research, one that operates on the model of circuit courts, so that relationships cannot easily develop between IRBs and the people seeking approval.” Taking IRB approval out of universities and for-profit review boards may very well improve things, since both can have financial incentives that result in failures to prioritize human subject protections. And modeling a new system around the circuit court system can bring much needed transparency and reduce conflicts of interest.
Sadly, Dreger ends her article with a second call that’s much more difficult to support: randomly “drafting” individuals for biomedical research as opposed to relying upon what she calls the sometimes “coercive” sums of money used to generate volunteers. The impetus for this suggestion comes from the right place; by making everyone a potential human research subject, perhaps more attention would be paid to protection.
However, the fatal flaw behind this proposal can be found in the first line of the Nuremberg Code: “The voluntary consent of the human subject is absolutely essential.” The research industry already engages in enough questionable practices that may violate basic ethical and human rights principles. Let’s not take one step forward in the name of fairness and equity to only take two steps back in taking our overall ethical responsibilities seriously.