Planned Emergency Research
FDA regulations allow certain planned emergency research to be undertaken when the intervention or interaction will be used on subjects unable to provide consent because of the emergency situation. A novel mechanism called “community consultation” must be utilized to alert the relevant community of this planned research before the IRB can give final approval. The regulations require consultation with representatives of (and public disclosure to) the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation. The conditions required to conduct this type of research with exception from informed consent are described in 21 CFR 50.24. and detailed in USC Human Research Protection Program Policies and Procedures.