Competence and consent to research: A critique of the recommendations of the national bioethics advisory commission*

An earlier version of this paper was presented at the 2nd National Ethics Conference on Research Involving Persons with Mental Disorders that May Affect Decision‐making Capacity, Baltimore, MD, November 1998.

Concern about the participation of incompetent subjects in psychiatric research has grown in the last several years. In response, the National Bioethics Advisory Commission (NBAC) recommended in its recent report that all investigations involving persons with mental disorders that may be associated with cognitive impairment that may pose greater than minimal risk to subjects utilize independent assessors to verify the capacities of subjects prior to entry into the study. This recommendation poses several problems for the conduct of research and the protection of research subjects. First, it fails to target that group of subjects most likely to be at risk for incapacity. Second, it focuses on too broad a range of research projects, many of which pose little risk to participants. The substantial costs of this approach are therefore not likely to be outweighed by concomitant benefits. In place of the NBAC recommendation, the author proposes a more flexible system of capacity assessment, designed to balance the costs with a greater likelihood of achieving meaningful protection for research subjects with mental disorders.

Keywords:

• Informed consent
• research
• human subjects
• competence
• decisionmaking capacity

Notes

An earlier version of this paper was presented at the 2nd National Ethics Conference on Research Involving Persons with Mental Disorders that May Affect Decision‐making Capacity, Baltimore, MD, November 1998.