Emily Anderson

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s.

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research.