Nationalizing IRBs for Biomedical Research – and for Justice
Research
Alice Dreger, 10/22/2010

Nationalizing IRBs for Biomedical Research – and for Justice

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I know that when my medical school sends us all an announcement that we’ve broken a record for funded research, I’m supposed to be happy. Wrong week for that.

Shortly before this, we 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 nonelective 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.

Picking up Carl Elliott’s new book only intensified my queasy suspicion. If you’re looking for something to spook you this Halloween season, I recommend this book of horrors. Among a lot of other frights, Elliott traces out how various types of IRBs are riddled with conflicts of interest. How universities who cooperate with drug and device makers by fast-tracking trials get more and more funding from them.

And then, taking a break from Elliott’s book, I came upon Susan Reverby’s findings with regard to John C. Cutler’s experiments in Guatemala. Among other travesties, Cutler purposely infected people with syphilis. Reverby has shown this work was supported by the U.S. Public Health Service, the NIH, the Pan American Health Organization, and so forth. So, yet another case of people putting institutional interest in findings and funding before ethics, even when they knew the project was ethically suspect.

Finally, I had to put down everyone else’s work and face my own recently failed attempts to ask IRBs to take better care of vulnerable subjects of biomedical experimentation. By the end of the week, I couldn’t help but feel like the more things change, the more they look like a fine old tradition. 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.

We have to do something already, no? We’ve reached the point where many people in medicine and medical ethics don’t even expect IRBs to act as something other than liability shields for their universities. But do patients who come to us only to be turned into subjects know that? Do they know that there is literally a price on their heads put there by research recruiters?

I’ve come to believe we need a radical solution. Maybe what we need 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 the IRBs and the people seeking approval.  This system could be run out of the Office for Human Research Protections and involve districts, similar to the federal courts system. Deliberations would be made transparent, so that all interested parties could understand (and question) decisions being made.

Think of the advantages: the possibility of actually focusing on the protection of human subjects first and foremost, free of conflicts of interest; the possibility of having nothing but trained professionals (not rotating unqualified faculty and staff) sitting on review panels; the possibility of marking biomedical research as clearly different from the social science and educational research unreasonably managed by many IRBs; the possibility of much greater transparency to those interested in seeing what’s going on; the possibility of having multi-center trials obtain a single approval from one centralized IRB, rather than trying to manage approvals from multiple local institutions. And the possibility of shutting down the deeply opaque, highly questionable private IRBs Elliott describes as being increasingly used by universities. (Go ahead, call me a Communist for caring about the Common Rule.)

And while I’m at it, one more suggestion about how to make biomedical research more ethical. In my e-mail conversation with the surgical researcher at my medical school, the man had asked me who would sign up for preliminary trials without coercive sums being offered? I think I’ve come up with a modest proposal for that problem.

Years ago, during the first Gulf War, I was walking in New York City with a friend who decades before had managed to escape being drafted into the Vietnam War. He hadn’t done any fancy finagling; he was just plain lucky in terms of his number not coming up. I mentioned to him how bad I thought the draft was, and he surprised me by responding he thought the draft was a great idea. Specifically, he explained, he thought we should draft everyone equally into war: grandmothers, young children, and even pregnant women. His logic? If we really faced who war can kill, we would stop going to war.

Reading Elliott’s account of the 1902 “Poison Squad” (young researchers turned into human subjects to find out which preservatives in food actually poison people) and Reverby’s findings on Guatemala (research carried out on prisoners and orphans), and thinking about the industry-sponsored surgical study at my university – all this brought me back to that long-ago conversation about the draft.

What if we drafted everyone into biomedical research? You know, fairly randomly – though perhaps starting with those who work for drug companies and medical device makers, and going next to their families? Might make us all more concerned with the protection of human subjects, yes? Better yet, maybe we should start with bioethicists. Now, that might really help.

If anybody asks, I’m an historian.

Alice Dreger is a professor of clinical medical humanities and bioethics at Northwestern University’s Feinberg School of Medicine.

Posted by Susan Gilbert at 10/22/2010 10:13:04 AM | 


The universal draft is an interesting idea - but it has been proposed for some years in the work of the UK utilitarian bioethicist, John Harris. Worth checking out.
Posted by: robert.dingwall@ntlworld.com ( Email ) at 11/2/2010 10:30 AM


thanks for his information
Posted by: ririncantik0@gmail.com ( Email | Visit ) at 4/13/2015 4:17 PM


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Posted by: anarcho80@gmail.com ( Email | Visit ) at 8/2/2015 11:16 AM


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