In June 2001, Ellen Roche, a healthy young technician at the Johns Hopkins Asthma and Allergy Center, died during an asthma study. The tragedy prompted several intensive investigations of research oversight at Johns Hopkins and led to the temporary suspension of all federally funded research projects at the institution. In this Health Policy Report, Steinbrook provides a detailed discussion of the outcome of the investigations, the response from Johns Hopkins, and the wider lessons for all involved in clinical investigation.