Enrolling Brain-Dead Humans in Medical Research: Stakeholder Opinions

Abstract

Background: Brain-dead humans retain many of the physiologic functions of living humans, but they are legally dead and cannot be physically harmed by participation in research. Stakeholder opinions about enrolling brain-dead humans in medical research are largely unknown. Methods: Exploratory interviews were conducted with members of three stakeholder groups—medical researchers, intensive care clinicians, and laypeople—to gauge support for and identify barriers to the conduct of research with brain-dead humans. Thematic analysis of interview transcripts was conducted based on a priori hypotheses and content analysis of interview transcripts. Results: Twenty-three of 31 participants (7/9 researchers, 8/10 clinicians, and 8/12 laypeople) indicated that research enrolling brain-dead humans who are not eligible for organ donation should be permitted, though all cited restrictions that should apply. Reservations about research involving brain-dead humans included (1) concern about maintenance of dignity or avoidance of desecration of the subject; (2) potential for a negative impact on surviving family members; (3) potential for a negative public reaction; and (4) potential for psychological harm to participating personnel. Specific restrictions that participants felt should be in place included (1) requiring consent from surviving families; (2) that such consent should be based on the substituted judgment standard; (3) that the research must have a high significance level; and (4) that the research must not interfere with organ donation or other clinical functions in the hospital. Conclusions: We found widespread support among key stakeholders for permitting research with brain-dead humans. Serious conceptual and pragmatic concerns dictate that research involving brain-dead humans should only be conducted in the context of careful limitations and safeguards.