FROM OVERSIGHT TO OVERKILL

Medical research is being stymied by the institutions charged with ensuring its safety, according to this exposé.

Whitney, a Baylor College of Medicine physician and bioethicist, pens a stinging critique of institutional review boards—the panels of scientists at universities and hospitals charged with vetting research proposals to ensure that human subjects are protected. They were created in 1974 to protect people from grossly abusive experiments, such as the infamous, decadeslong Tuskegee Study that withheld lifesaving treatment, resulting in more than 100 deaths. However, in the present day, Whitney argues, these boards have become so bureaucratic and risk-averse that they’re impeding important research projects. One board, he notes, demanded that a doctor submit an extensive bibliography on safety issues for a study that had no participants at all, as it consisted of analyzing proteins in leftover urine samples from a kidney-stone clinic. Equally absurd, he asserts, are extensive consent forms, full of dense legalese, which participants must understand before signing. In one study of the benefits of commonly prescribed anti-clotting drugs for cardiac patients, he says, subjects were asked to read and sign four-page consent forms while experiencing the early stages of heart attacks. Whitney ties such dysfunctional elements to the federal Office of Human Research Protections, whose dictates, he says, drive the excesses of such boards. In one incident that he spotlights, the office tried to stop a study aimed at preventing infections when implanting center-line tubes because the doctors and nurses involved didn’t also sign consent forms along with their research subjects. The upshot of all of this, Whitney asserts, is that crucial studies are being delayed or abandoned at a high cost for patients whose lives might be saved by faster research.

Whitney, who served on a Stanford University institutional review board in the 1990s, brings a canny insider’s perspective to a convoluted issue. He deftly analyzes the ethics that underpin board dysfunctions, noting that they fixate on trivial risks without balancing them against the needs of patients who need lifesaving treatments—or granting subjects the moral autonomy to take measured risks for greater humanitarian ends. Also, he’s shrewdly critical of the sorts of regulatory box-checking that affects every step of the review process. These problems can be hard to see in the obscure nuances of complex scientific studies, and Whitney does an admirable job of teasing them out and clarifying them for an audience of laypeople. He conveys all of this in a prose style that’s lucid, down-to-earth, and tartly entertaining: “I am sure that, acting alone, no single member could reach this level of crazy. It took a village,” he writes of a board that saw a potential threat of AIDS or smallpox in a study that involved swabbing the skin of healthy volunteers and rubbing the swabs on other healthy volunteers in order to explore changes in the microbiome.Overall, this is a telling study of administrative overreach that makes a case that institutional imperatives sometimes eclipse rational purposes.

A carefully reasoned and disturbing portrait of potential hazards of excessive regulation.