Behind Closed Doors: IRBs and the Making of Ethical Research

  • Laura Stark
University Of Chicago Press, 2012 240 pp., paperback, $27.50 0226770877 | ISBN: 0-226-77087-7

From my perspective as an institutional review board (IRB) 'insider' (who has established human subject protection programs for both a government agency and an academic institution), I approached reviewing Behind Closed Doors with concern due primarily to what I perceived to be a depreciatory title. In choosing this title, Laura Stark, the book's author, seems to imply that the workings of IRBs are opaque and secretive, although in my view the process itself is transparent and accessible. In fact, after I read the book, many of my apprehensions turned out to be justified.

Stark is a sociologist at Wesleyan University who spent time as a postdoctoral fellow in the US National Institutes of Health (NIH) Office of History. In her book, Stark explores how research guidelines—both legal and ethical—were designed in the aftermath of World War II. She believes that in defining such rules, the NIH catered primarily to the interests of government researchers. This resulted in the present-day models of reviewing human subject research, of which she is critical. From the title to the last page, Behind Closed Doors seems to be written in a style that is not neutral or dispassionate and does not hypothesize alternative motives for IRB conduct.

The book is written in two parts that are so dissimilar that no clear relationship is apparent to me. In addition, the two parts are of unequal scholarly rigor, with the first part being, to my view, anecdotal and the second part being heavily resourced.

The first part of the book relies on a technique frequently employed by academics, whereby a couple of observations are used to represent an entire population. Stark observes one or two IRBs and interviews a handful of IRB members, yet goes on to make sweeping generalizations. Her use of direct quotes from IRB members seems highly selective and creates a very negative, and not necessarily accurate, impression of how IRBs operate. She paints a picture of IRBs kidding themselves into thinking that because they work as a group they will make fair decisions. A competent IRB with a strong chairperson would not be lapsing into the kind of personal one-upmanship that Stark encounters. She also attributes negative value to IRB minutes, which she sees as a shield to protect the motivations of IRB members because the names of attendees are not provided in the minutes. In reality, the content and form of the minutes are carefully defined by federal guidelines, and all controverted issues are documented. IRB discussions are reflected in the minutes only to the extent that they define what expectations are made of the researcher and allow a wide-ranging and frank discussion that individual attribution would prevent.

Stark believes IRB members have too much personal discretion in their enforcement of research regulations. She claims that the status quo is most likely to be enforced, not challenged, by an IRB, resulting in the rigid and bureaucratic way the research review and approval process is currently designed and implemented. Although I agree that IRB procedures can be rigid and bureaucratic, I don't think individual IRB members have the control over IRB decisions that Stark seems to imply. Over time, guidelines and additional oversight have helped to evenly distribute influence among IRB members.

Stark suggests that IRB members are too far removed from the interests of the parties involved in research—the researchers and subjects—and do not always take their needs into account. Thus, Stark claims that the IRB cannot truly be protecting the subjects. However, many IRBs I have observed do allow researchers to be present or to justify their work, and community members are charged with speaking for the interests of the subjects. Ironically, it seems to me that Stark herself omits the voices of researchers and subjects in the book .

Despite the overall negative tone, I did gain many new insights reading the second part of the book. Stark documents how the NIH Clinical Center scientists, acting in their capacity as administrators and policy writers, created a review system to benefit their research ventures rather than risk political intervention. In addition, I learned that when human studies required greater numbers of participants, the research system at the NIH Clinical Center was the first to use normal healthy subjects, including conscientious objectors and prisoners.

Another revelation for me came from Stark's description of the extreme efforts by NIH administrators and researchers to resist proposed mandatory informed consent laws. The reader cannot help but compare the NIH resistance to mandatory informed consent to the experiments conducted by Nazi doctors that had recently been uncovered at the time informed consent procedures were being designed. The current controversy over physicians and mental health professionals involved in coercive 'research' with detainees at Guantanamo Bay, for example, echoes many of these same abuses committed by Nazi doctors. The second part of the book would be better if the extensive notes in the back of the book had been directly incorporated into the material.

People in the field of human subject research protection can agree that the current system is in need of an overhaul. I agree with Stark's premise that IRBs are ambiguous, overly zealous and inconsistent; however, I believe the cause lies with the federal government and its system of interpreting regulations, issuing guidance at whim and demanding rigid adherence to 'rules'. I therefore take issue with Stark's proposed solutions: a universal research code to be applied by individual researchers and a single centralized federal review body responsible for the implementation of the research code. I challenge the reader to identify a centralized federal body that works as intended, and I would not trust the findings that are reported by self-regulating researchers.