• Should IRBs be dismantled?

    If you have any interest at all in ethics and scientific research, read Carl Schneider’s new book. Don’t bother reading this post. Just read the book. It’ll change how you think about the legal regime that we’ve got in place for regulating human-subjects research.

    The book, The Censor’s Hand, targets the Institutional Review Board (IRB) system. Federal law requires university researchers to get approval for any “human subjects research” from their institution’s IRB, a committee comprising mainly members of the faculty. Established in response to the appalling syphilis experiments in Tuskegee, IRBs have a beneficent purpose: to assure that academic research meets the highest ethical standards.

    That beneficent purpose notwithstanding, Schneider draws on a wealth of empirical research to make the case that IRBs do more harm than good. His arresting conclusion is that we’d be better off scrapping IRBs altogether. (Full disclosure: Schneider is a colleague and a friend, and I commented on an early version of the book.)

    Schneider opens by trying to tally the benefits of IRB review. “Surprisingly,” he writes, a careful review of the literature suggests that “research is not especially dangerous. Some biomedical research can be risky, but much of it requires no physical contact with patients and most contact cannot cause serious injury. Ill patients are, if anything, safer in than out of research.” As for social-science research, “its risks are trivial compared with daily risks like going online or on a date.”

    Since the upsides of IRB review are likely to be modest, Schneider argues, it’s critical to ask hard questions about the system’s costs. And those costs are serious. To a lawyer’s eyes, IRBs are strangely unaccountable. They don’t have to offer reasons for their decisions, their decisions can’t be appealed, and they’re barely supervised at the federal level. That lack of accountability, combined with the gauzy ethical principles that govern IRB deliberations, is a recipe for capriciousness. Indeed, in Schneider’s estimation, IRBs wield coercive government power—the power to censor university research—without providing due process of law.

    And they’re not shy about wielding that power. Over time, IRB review has grown more and more intrusive. Not only do IRBs waste thousands of researcher hours on paperwork and elaborate consent forms that most study participants will never understand. Of greater concern, they also superintend research methods to minimize perceived risks. Yet IRB members often aren’t experts in the fields they oversee. Indeed, some know little or nothing about research methods at all.

    IRBs thus delay, distort, and stifle research, especially research on vulnerable subgroups that may benefit most from it. It’s hard to precise about those costs, but they’re high: after canvassing the research, Schneider concludes that “IRB regulation annually costs thousands of lives that could have been saved, unmeasurable suffering that could have been softened, and uncountable social ills that could have been ameliorated.”

    There’s a temptation to shrug and say that, yes, IRBs are sometimes excessive, but they’re necessary to prevent genuine evils. Otherwise, how would we police ethics in research? Wouldn’t ethical breaches be rampant?

    Schneider thinks not. He points out, rightly, that IRBs aren’t the only cops on the beat. “Funders often review research ethics. Injured subjects may sue researchers for damages, as injured patients may sue doctors. Unethical researchers risk formal and informal professional sanctions, including loss of standing, funding, and jobs. Those sanctions can be much increased, even through criminal penalties.” Schneider’s not against regulating research; he’s just against bad regulation.

    But even if you don’t buy Schneider’s argument that IRBs should be dismantled, his book offers a compelling and dismaying portrait of a regulatory scheme in need of a serious overhaul. If you care about research, you should care about finding a better way to regulate it. Take a first step by reading the book.

    @nicholas_bagley

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