Planned Emergency Research And Exception From Informed Consent

Informed consent is a cornerstone of ethical research, but the United States (U.S.) federal regulations permit institutional review boards (IRBs) to waive consent under certain conditions. One such situation is planned emergency research (often referred to as research involving an exception from informed consent, or EFIC). This white paper focuses on key issues of interest to sponsors who may be interested in planning and designing EFIC studies, sites and investigators conducting EFIC research, and IRBs charged with reviewing EFIC studies. This paper explains the defining features of planned emergency research and unpacks the regulatory criteria that must be satisfied for this research to proceed. It also looks closely at two defining features of EFIC research: the requirement for community consultation and public disclosure of key research features prior to the clinical investigation’s initiation. 

To learn more about Advarra, visit their Clinical Leader page.