Many of the current human subject protections were formed with the disastrous consequences of the well-known Tuskegee Syphilis Study in mind. While we all hope that these rules have made the practice of human subjects research safer, they cannot prevent future disasters without the reliable performance of the individuals and organizations. The Kennedy Krieger Institute Lead-Based Paint Study (KKI), in which researchers measured the blood lead levels of children living in homes that received differing methods of lead abatement, for example, became a public scandal and legal disaster many years after Tuskegee, even though the study was reviewed by institutional review boards (IRBs). Will IRBs fail to stop similar studies in the future? What can institutions do to decrease the likelihood of seeing another Tuskegee or KKI debacle in the future?
To begin to answer these questions, Barry Bozeman, Catherine Slade and Paul Hirsch in “Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board” propose studying the organizational behavior of IRBs. The authors assert that IRBs as organizational systems are functioning well with a large number of low-risk, routine decisions, but are more likely to fail when confronting idiosyncratic and novel decisions. The authors point to the KKI case as an example and note: “There is no evidence that IRB procedures differed significantly in this case from hundreds of other instances, ones that drew less attention and escaped the wrath of the press and the public.” In other words, the day the KKI study was approved, the IRB was just doing its job, but (we know now) that clearly was not enough.
Before addressing these potential vulnerabilities in IRB decision making, the authors propose that IRBs themselves become the subject of future behavioral research studies. They propose three well-used methods: case studies, survey research, and experiments or simulations. While IRB members and the institutions they serve might resist studies of their decision making behavior, the authors remind us: “There is no reason to assume that IRB processes should prove a more intractable learning environment than, say, corporate board rooms, air control towers, space centers, or war rooms.”
Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health. 2009 Sep;99(9):1549-56. PMID: 19608947
Bozeman B, Hirsch P. Science ethics as a bureaucratic problem: IRBs, rules, and failures of control. Policy Sci. 2006; 38:269–291. doi:10.1007/s11077-006-9010-y
Buchanan DR, Miller FG. Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions. Am J Public Health. 2006 May;96(5):781-7. PMID: 16571697
Candilis PJ, Lidz CW, Arnold RM. The need to understand IRB deliberations. IRB. 2006 Jan-Feb;28(1):1-5. PMID: 16680872
— J. O.