This paper examines the death of Jesse Gelsinger in 1999 during a clinical trial at the University of Pennsylvania using an analytic approach derived from Vaughan’s synthesis of thinking about organisational failure and white-collar deviance. It describes the competing narratives from Federal regulators and the University before outlining the relevant theoretical sources. The nature of science as a quasi-economic enterprise is discussed, noting the similarities to, and differences, from the capitalist organisations studied by Vaughan. The constraints on regulatory effectiveness in innovative organisations are explored and the problems of authority leakage and internal censorship are shown to be endemic. In conclusion, the effectiveness of organisational responses that depend either on more elaborate command and control or on the outsourcing of risk are questioned. The most effective reconciliation of human subjects protection with the potential collective benefits of scientific research does not seem likely to be achieved by more elaborate rules and organisational obligations.
© 2001 by Lucius & Lucius, Stuttgart