IRB: Ethics & Human Research

Capacity to Consent to Research in Patients with Acute Pain: A Pilot Study

Although pain is identified as a characteristic that makes potential research participants a vulnerable population requiring special protections, few studies have formally evaluated the decisional capacity of individuals in acute pain to provide consent for research. Multiple instruments are used to assess capacity to consent for research in populations requiring special protections, but none of these instruments had beentested in patients with acute pain. We used the Macarthur Competence Assessment Tool for Clinical Research (MacCAT-CR) to assess the capacity to consent to research of patients with moderate to severe acute pain in one urban emergency department serving a primarily indigent minority population. The MacCAT-CR measures four components (understanding, appreciation, reasoning, and expression of a choice) that are considered part of the ethical and legal definition of capacity. The data collected indicates that most patient-participants in our study (77%) demonstrated adequate understanding, and there was no correlation between pain and performance on any of the MacCAT-CR subscales. Future multicenter studies using similar methods should be performed on a larger population of patients in acute pain to confirm our results.

Key words: ethics, research, bioethics, decision making, informed consent, pain management

Ethan Cowan, Hadassa Klerman, and Jeffrey Ma. Capacity to consent to research in patients with acute pain: A pilot study. IRB Ethics & Human Research 2015;37(3):1-6.