The Function of—and Need for—Institutional Review Boards - Pacific Standard

The Function of—and Need for—Institutional Review Boards

The system may be flawed, but dismantling it altogether is certainly not the answer.
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The Censor's Hand: The Misregulation of Human-Subject Research. (Photo: The MIT Press)

The Censor's Hand: The Misregulation of Human-Subject Research. (Photo: The MIT Press)

The Censor's Hand: The Misregulation of Human-Subject Research
Carl E. Schneider
The MIT Press

Scientific research can be a laborious and frustrating process even before it gets started—especially when it involves living human subjects. Universities and other research institutions maintain Institutional Review Boards that scrutinize research proposals and their methodologies, consent and privacy procedures, and so on. Similarly intensive reviews are required when the intention is to use human tissue—if, say, tissue from diagnostic cancer biopsies could potentially be used to gauge the prevalence of some other illness across the population. These procedures can generate absurdities. A doctor who wanted to know which television characters children recognized, for example, was advised to seek ethics committee approval, and told that he needed to do a pilot study as a precursor.

Today's IRB system is the response to a historic problem: academic researchers' tendency to behave abominably when left unmonitored. Nazi medical and pseudomedical experiments provide an obvious and well-known reference, but such horrors are not found only in totalitarian regimes. The Tuskegee syphilis study, for example, deliberately left black men untreated over the course of decades so researchers could study the natural course of the disease. On a much smaller but equally disturbing scale is the case of Dan Markingson, a 26-year-old University of Michigan graduate. Suffering from psychotic illness, Markingson was coercively enrolled in a study of antipsychotics to which he could not consent, and concerns about his deteriorating condition were ignored. In 2004, he was found dead, having almost decapitated himself with a box cutter.

Many thoughtful ethicists are aware of the imperfections of IRBs. They have worried publicly for some time that the IRB system, or parts of it, may claim an authority with which even many bioethicists are uncomfortable, and hinder science for no particularly good reason. Does the system need re-tuning, a total re-build, or something even more drastic?

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When it comes to IRBs, Carl E. Schneider, a professor of law and internal medicine at the University of Michigan, belongs to the abolitionist camp. In The Censor’s Hand: The Misregulation of Human-Subject Research, he presents the case against the IRB system plainly. It is a case that rests on seven related charges.

IRBs, Schneider posits, cannot be shown to do good, with regulators able to produce "no direct evidence that IRBs prevented harm"; that an IRB at least went through the motions of reviewing the trial in which Markingson died might be cited as evidence of this. On top of that, he claims, IRBs sometimes cause harm, at least insofar as they slow down medical innovation. They are built to err on the side of caution, since "research on humans" can cover a vast range of activities and disciplines, and they struggle to take this range into proper account. Correspondingly, they "lack a legible and convincing ethics"; the autonomy of IRBs means that they come to different decisions on identical cases. (In one case, an IRB thought that providing supplemental vitamin A in a study was so dangerous that it should not be allowed; another thought that withholding it in the same study was so dangerous that it should not be allowed.) IRBs have unrealistically high expectations of their members, who are often fairly ad hoc groupings with no obvious relevant expertise. They overemphasize informed consent, with the unintended consequence that cramming every possible eventuality into a consent form makes it utterly incomprehensible. Finally, Schneider argues, IRBs corrode free expression by restricting what researchers can do and how they can do it.

These charges, though, are not as damning as they appear; some of the problems are straightforwardly explicable. IRBs can be used as a preemptive defense against negligence charges, allowing institutions to say, when things go wrong, that they had at least taken reasonable precautions. Moreover, the laws that set the terms within which ethics committees work have to be phrased broadly in order to be workable. Combine this with the fact that there is (in many countries) no overarching organization to manage them, and the absence of a uniform ethic is also unsurprising. Besides, one man's incoherence is another man's flexibility and a third's admirable diversity.

A reformist case could accommodate and make use of these considerations, but Schneider's abolitionism does not and cannot. Some of Schneider's accusations, moreover, are straightforwardly ill-founded. Markingson's death, for example, shows the need for more and better IRB input, not less. For sure, IRBs cannot easily be shown to do good, and no one speaks out when IRBs make sensible and efficient suggestions, and no one can say much about disasters that didn't happen. More importantly, though we may laugh at a back-of-the-envelope study about children's TV characters requiring a lot of prep work, the idea that children are vulnerable and that any research involving them should minimize cohort size while maintaining statistical significance seems admirable. Maybe this particular study should have been treated as an exception—but then, isn't it better to have IRBs rather than researchers deciding on what is exceptional?

Most importantly, IRB scrutiny is not censorship. There's no complex argument needed here. It's perplexing, too, that one of the quotations used in Schneider's book to make the assertion that the function of IRBs is "offensive ... to the values protected by the First Amendment [and] a free society" actually comes from Watchtower v. Stratton, a case concerning door-to-door proselytization by Jehovah's Witnesses. Unless one thinks (implausibly) that preaching and research are effectively the same thing, much more would have to be done to show that the point translates. As it stands, it looks as though Schneider has resorted to irrelevant sources to make his case—and it's hard to resist the worry that the lack of a clear reference might have been intended to obscure that irrelevance.

Schneider's suggested alternatives to IRBs are bizarre. He takes it as a given that research is "generally structured to minimize risk" without considering that this may be because of IRBs, not in spite of them. For him, research funders can act as ethical gatekeepers (he doesn't consider any possible conflicts of interest), and if something does go wrong, "injured subjects may sue researchers for damages" or avail themselves of criminal sanctions—which is hardly protection, and comes much too late anyway.

Schneider does himself no favors in his presentation of an already weak case. His targets are personified as "regulationists," a spooky band that seems to be composed of meddling do-gooders of whom all right-thinking people naturally disapprove. But in this, he has done nothing more than to construct an Aunt Sally, and a direct result of the prioritization of complaint over balanced argument is that the book is, sadly, often almost unreadably boring. Points are labored rather than developed, and much of the book is a parade of quotations. There are 1,084 references within this fairly short work, and the effect is dizzying rather than illuminating. Worse, many quotations are poorly or inaccurately referenced, if they're referenced at all. One passage talks about research on adolescent sexuality and on drugs for childhood asthma, with quotations about both, though no reference is provided for the former. This is confusing. Elsewhere, a comment about the role of IRBs in the gene-therapy trial that killed Jesse Gelsinger is supported by a quotation attributed to the Oxford bioethicist Julian Savulescu that is actually from a 2004 paper by Richard Saver, who gets no credit. (The quotation, incidentally, seems to say the opposite of what Schneider thinks it does.) This is a very poor show.

The Censor's Hand is likely to appeal to true believers in the abolitionist cause, but probably will not persuade anyone else. It's not obvious that those whose minds people like Schneider would need to change have the patience to finish his book.

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