Title |
Exception from informed consent for emergency research
|
---|---|
Published in |
Journal of Trauma and Acute Care Surgery, The, January 2013
|
DOI | 10.1097/ta.0b013e318278908a |
Pubmed ID | |
Authors |
Carrie A. Sims, Joshua A. Isserman, Daniel Holena, Latha Mary Sundaram, Nikolai Tolstoy, Sarah Greer, Seema Sonnad, Jose Pascual, Patrick Reilly |
Abstract |
Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member. |
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