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As the clinical specialties of emergency medicine and prehospital medicine developed, patients who otherwise would have died in the field began to survive to reach the ED. It soon became apparent that existing emergent treatments for many critical conditions were unsatisfactory and/or were understudied. However, traditional methods of obtaining prospective informed consent for research participation are not feasible when a devastating pathology deprives patients of meaningful decision- making capacity. With that in mind, a set of regulations was developed by the Federal regulatory agencies in USA; this allows for exception from informed consent (EFIC) in emergency research in specific clinical circumstances1 and went into effect in 1996. The emergency medicine community was the key driver in the creation of these regulations.2 ,3
The criteria for EFIC studies are well defined and are briefly summarised in box 1. Among these requirements is prestudy community consultation, aimed at
‘providing the opportunity for discussions with and soliciting opinions from the community(ies) in which the study will take place (geographic area) and from which the study subjects will be drawn (similar demographics of patients with the emergent condition under study). These communities may not be the same; when they are not the same, both communities should be consulted…’.1It is an opportunity to allow information exchange, ensures that the community’s concerns are known when the institutional review boards (IRBs) and ethics committees engage in decision-making about potential EFIC studies and allows investigators to consider information related to the study that may not otherwise have been apparent to the scientific community.
Major criteria for exception from informed consent (EFIC) requirements summarised1
Condition under study is devastating and currently available treatments are unproven or unsatisfactory
Time is critical for application of the study intervention and the …