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.
Additionally, the therapeutic window does not allow sufficient time to contact a legally authorized representative (as defined by the state in which the research is being conducted) to obtain prospective consent. Further, the possibility must exist that the subject will directly benefit from participation in the study.