Research participant safety and systems factors in general clinical research centers.

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patient injuries has identified important and common system failures.2 One definition describes system as a collection of interdependent elements that interact to achieve common purpose.3 In clinical medicine, this would include healthcare system elements relevant to patient care. These include everything from emergency rooms to ambulatory clinics, laboratory services, and hospital services. Qualitative research in non-medical industries such as aviation and nuclear power reveals that organizational factors such as poor communication, inadequate training, and excess workloads appear to produce environments that facilitate human errors.4 A systems approach towards organizational safety steers away from blaming single individual and looks to identify and correct other organizational factors that might have triggered an adverse event.5 Clinical research shares many features with clinical medicine. In both situations, patients or participants may be exposed to high-risk procedures or medications. For example, both research participants and clinical patients undergo similar routine procedures, such as the insertion of an intravenous or Foley catheter. Identifying toxicities or side effects requires use of similar monitoring procedures, whether in the research or clinical context. Just as with clinical medicine, system failures likely exist within clinical research6 and might result in adverse outcomes.7 One salient example comes from the case involving the tragic death of Ellen Roche, research subject in study conducted at Johns Hopkins University.8 During the time period in which Ms. Roche was research participant, protocols submitted to the university's Institutional Review Board (IRB) were only formally discussed by

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