Impediments to obtaining informed consent for clinical research in trauma patients

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.

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.

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.

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.