“Near-miss” Reporting System Development and Implications for Human Subjects Protection

Background: Reviews of recent research-related fatalities have demonstrated that clinical research system failures likely contributed to the event. Current research safety-reporting mechanisms focus on individual protocols and are therefore less likely to detect system-level failures. Methods: We have implemented the “nearmiss” reporting system for a general clinical research center to detect latent failure within the research environment. Results: An identified research-related near miss includes a research volunteer being mistakenly directed into an incorrect protocol. Before beginning the incorrect study, the participant recognized that the protocol did not coincide with the consent document and the error was detected without harm. Lack of both reliable research-participant tracking and verification programs was believed to be an important latent failure associated with the research unit. Discussion: Collecting research unit-specific information on potential safety concerns could identify system failures that might not be identifiable through traditional human subjects protection programs.