ABSTRACT
Roche was participating in an asthma research study to 'explore how the tubes that carry air into the lungs can stay open when irritants are inhaled'. Roche inhaled a chemical called hexamethonium, which was used for treating high blood pressure, but the FDA removed it from the market in 1972 because it was ineffective. Roche died of progressive low blood pressure and multiple organ failure. Roche's death triggered an investigation into the Institutional Review Board (IRB) and research practices at Hopkins. Details of the Roche incident and the analysis of the event were shared with the interested public in a transparent manner. This incident provides a well-documented failure with specific changes enacted to improve the reliability and validity of a clinical trial program. In addition, the EI&K failures inherent in several aspects of this incident are available for deconstruction toward the goal of learning from tragic human error and systemic incidents.
