Research Ethics and Policy Series (REPS): Justin Clapp, PhD, MPH

Exception from informed consent (EFIC) regulation: Good intentions, indeterminate concepts, bureaucratic absurdities

Justin Clapp, PhD, MPH 
Assistant Professor, Anesthesiology & Critical Care and Medical Ethics & Health Policy, Perelman School of Medicine; Associated Faculty, Anthropology, School of Arts and Sciences 

 Abstract: Prospective informed consent is sometimes not feasible in emergency medical research due to patient incapacitation, short therapeutic windows, and the unavailability of surrogates. In 1996, the U.S. Food and Drug Administration (FDA) established the exception from informed consent (EFIC) regulatory pathway, which allows trials of emergency medical interventions to proceed without prospective consent so long as researchers fulfill an array of pre- and post-study requirements. The most substantial of these requirements is ‘community consultation.’ Ostensibly a substitute for individual consent, community consultation requires researchers to solicit public concerns about their trials and report them to the institutional review board before obtaining approval. However, there has been considerable uncertainty among EFIC investigators about the methods and goals of community consultation. Drawing on interviews with EFIC investigators and my own ongoing involvement in a community consultation process, this talk will critically reflect on what EFIC regulation is accomplishing 25 years after its establishment. 

Via Zoom. Register in advance: https://upenn.zoom.us/meeting/register/tJErceuuqTojE93V_Urey7lt9ghi1pqq9tD8 

Information: Mary Pham, Mary.Pham@pennmedicine.upenn.edu