The Censor’s Hand: The Misregulation of Human-Subject Research by Carl E. Schneider (review)

The Censor’s Hand invites us to explore the murky side of formal research-ethics review in the United States, as embodied in “Institutional Review Boards” (IRBs). Amidst some 340 publications and several blogs that have taken formal research-ethics review to task, this book is the seventh detailed monograph on this topic—the others are Robert Klitzman’s The Ethics Police? (2015), Zachary Schrag’s Ethical Imperialism (2010), Laura Stark’s Behind Closed Doors (2011), and my own works, Walking the Tightrope (2002), The Seduction of Ethics (2011), and The Ethics Rupture (forthcoming). This is a particularly welcome volume. It is the second that comes from the hands of someone in medicine (Schneider is a professor of internal medicine). With surgical precision, The Censor’s Hand lays bare the inner workings and the social context of IRBs.

The Introduction traces the history and evolution of research-ethics review. The authority of the IRBs is total. They “not only have virtually plenary discretion, their decisions are procedurally insulated from challenge” (xxi). Schneider divides The Censor’s Hand into two thematic parts. Part I explores the IRB system’s costs and benefits. Part II avers that the very structure, incentives, and ethos of IRBs impair the ability of IRBs to make decisions relevant to ethics in research (xxviii). In chapter 1, Schneider asks how much good IRBs can do; they can hardly help doing more harm than good. He centers the whole question on the assessed risks that research participants are subjected to. In a procedure that significantly reduced fatalities in intensive care, the Office of Human Research Protections (OHRP) was alarmed that this procedure-turned-research was conducted without informed consent. In this and other cases, IRBs define just ordinary medical care as “research,” and are thereby creating obstacles to saving lives. Resorting to “emblematic” disgraces, the IRB systems use “scandals” to fortify their belief that the protection of human participants must always be at the forefront of their concerns (5). “With mounting zeal but minimal evidence,” Schneider writes, “regulationists treat nonphysical harm as both serious and probable” (15). This “panoptic gospel” thrives on warning researchers about the risks inherent in all research (24–25). The section, “Justifying the IRB System,” constitutes a very fine account of how alleged scandals feed into the risk frenzy that beset IRBs (122–124). [End Page E-11]

Chapter 2 reiterates what The Censor’s Hand argues in the Introduction, namely that the IRB system is an “extravagant system” of “command and control,” animated by “the distrust, even demonization, of researchers” (xxvii). Bureaucratization, Schneider avers, delays, distorts, stops, and deters research (xxviii). The costs and the fetishization of paperwork constitutes the system’s extravagance (34). They also comprise a “tax” on research, reducing available funds for research as well as time for researchers to do their work (40). In this context, the system “pushes scholarship towards the blandness that leave IRBs unperturbed” (60).

The book reminds us of some cases of the glaring misapplication of ethics rules such as asthma-surgery (49); observed children who play tag must fill out consent form (53); adult respiratory distress syndrome (73–74); Vitamin A (75–78); fired patients (91–93); tonsils and use of codeine (95–96); terror (108–109)—all of which Schneider has indexed in the book. Even exploring free hospital parking to encourage parents to visit their premature babies in neonatal intensive care units falls under “research.” The hospital wanted proof that free parking would help parents and their babies. IRBs also intrude into administrative issues and pedagogy (61). “IRB regulation,” we learn, “annually costs thousands of lives that could have been saved” (62). Daringly, The Censor’s Hand proclaims that since the IRB system costs in human life, health, welfare, and dignity outstrips its benefits, the system cannot be justified and thus ought not be retained” (66). The IRBs’ “indeterminate” and “perverse ethics” drives those decisions; lawlessness and unaccountability degrade their decisions (67). Chapter 3 moves...