ASSOCIATION FOR ACADEMIC SURGERY Ethical and Legal Issues in Emergency Research: Barriers to Conducting Prospective Randomized Trials in an Emergency Setting

Introduction. 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. Methods. A literature review was conducted on areas affecting emergency medical research including: informed consent, socioeconomic and racial disparities, federal regulations in trauma research and biomedical ethics. Results. Inthetenyearperiod followingthepassage of the FDA’s Common Rule (21 CFR 50.24) in 1995, 21 published emergencyresearch studieswereconducted under the waiver of informed consent. Misconceptions regarding federal regulations and cumbersome internal review board approval processes are frequently cited as significant barriers to conducting prospective randomized trials in the emergency setting. Conclusions. 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 ofinformedconsentisunabletobeachievedasinother