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Defining "Community" and "Consultation" for Emergency Research that Requires an Exception from Informed Consent
1A professor in the Department of Surgery and the Program in Trauma at the University of Maryland School of Medicine in Baltimore. He also serves as director of the Surgical Intensive Care Unit and the Center for Critical Care and Trauma Education at the R Adams Cowley Shock Trauma Center, part of the University of Maryland Medical Center.
Abstract:
Trauma care requires rapid interventions to optimize the chances for survival. Many patients are either in shock or unconscious and are, therefore, unable to provide informed consent even for standard procedures. Research-related interventions must similarly be initiated rapidly with no opportunity to obtain consent from the patient or the patient's legally authorized representative. Federal regulations allow for an exception from informed consent in these circumstances once the investigators complete a process of community consultation and public disclosure. The challenges for investigators include how to define the at-risk community for enrollment in the trial and then how to adequately reach out to that community. Many approaches have been used, with varying success. What constitutes true engagement with the community needs to be further explored.