Impediments to obtaining informed consent for clinical research in trauma patients

Abstract

Background: Informed consent is required for, but a substantial barrier to, clinic research in trauma care. Exceptions have been established but remain controversial, and little objective data are available to illuminate this debate.

Methods: We prospectively assessed 2,011 consecutive patients admitted to the R Adams Cowley Shock Trauma Center of the University of Maryland Medical System for the potential to give consent for a hypothetical research trial within 1 hour of admission or whether consent could be obtained from a legally authorized representative (LAR) within 3 hours. These data were then linked with demographic, transport, physiologic, and injury data.

Results: Complete data were available for 1,734 patients: 982 (57%) appeared able to consent and 752 (43%) appeared unable to consent. Of the latter, LAR consent was potentially available for 404, leaving 348 (46%, 20% of all admissions) unconsentable. Those apparently able to consent were significantly less injured than those unable, but a third were subsequently found to have objective barriers to giving consent, and a further third had findings strongly suggestive of impairment. For those unable to consent, subsequent LAR consent was strongly associated with being a minor or being a woman. Lack of LAR consent was strongly associated with being the victim of intentional injury, with being an African-American male and-for European-American men only-with being transported greater distances.

Conclusions: Severely injured trauma patients can seldom provide consent for research studies, and LARs are often unavailable. Further efforts to develop workable mechanisms for exception from informed consent are justified.