Decision‐making capacity and disaster research

The extent to which victims of a disaster are able to make capacitated and voluntary decisions to enroll in research is an important and virtually unexplored question. Although there are no compelling data to suggest that experiencing a severe trauma, in and of itself, renders all or even most individuals incapable of making autonomous decisions, the assessment of decision‐making capacity (DMC) for research participation warrants serious consideration. This paper provides a framework for and procedural approach to the assessment of DMC in research with individuals exposed to disaster. Particular attention is paid to the implementation of additional safeguards to protect subjects who are vulnerable by virtue of impaired DMC. Recommendations are offered to clinical investigators, ethical review boards, and policymakers with regard to the design, review, and conduct of research in the aftermath of disaster.