The Function of—and Need for—Institutional Review Boards

Review by  of 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?

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….(More)”