The Journal of surgical research
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As in any area of medicine, clinical trials are crucial to the advancement of trauma care and the establishment of evidence-based guidelines. This work identifies consent regulations that impede advances in trauma resuscitation research and examines several ethical issues underlying current policies in the United States which regulate how clinical trials are conducted in an emergency setting. Trauma is a leading cause of mortality in the U.S. Minorities and those in low socioeconomic groups are subject to a disproportional amount of traumatic injuries and have worse treatment outcomes than non-minority individuals. Current regulations guiding consent requirements in emergency research were enacted to protect such vulnerable populations from exploitation. Ironically, these same regulations also serve as barriers to clinical trials in trauma research, thus depriving these same vulnerable groups from the benefits of advances in trauma care. ⋯ Given the history of past abuses in medical research, the principle of maintaining autonomy of choice is of paramount importance. However, trauma resuscitation is unique in that patients are either unconscious or of limited mental capacity at the time treatment is required, and thus the standard of informed consent is unable to be achieved as in other areas of medicine. While this paradox was recognized by the FDA in 1995 with the creation of an exception to the requirement for informed consent in emergency research (the "Common Rule"), the wording of this exception is ambiguous, and has consequently deterred trauma investigators from pursuing valuable research endeavors. In particular, the language requiring "community consultation" and demonstration that existing treatments are "unproven or unsatisfactory" have been identified as the most problematic terms to satisfactorily address by those aiming to conduct trauma research. It is imperative that the current exemptions to the Common Rule be more thoroughly operationalized, so that greater advancement in emergency medicine research can be promulgated, while concurrently maintaining a high standard of protection for the rights of trauma patients.