ABSTRACT

Henry Beecher, a pioneer of research ethics, wrote in 1959 that this principle would “effectively cripple if not eliminate most research in the field of mental disease.” The National Bioethics Advisory Commission (NBAC) considered some of these changes, but nevertheless made the fundamental and highly controversial decision to focus its report on persons with mental disorders that may affect the capacity to make decisions rather than on all potential research subjects with actual or probable impaired capacity. The NBAC considers the present system for evaluating a patient's capacity to consent to dangerous treatment inadequate even to assess the capacity to consent to magnetic resonance imaging for research purposes. Another good suggestion is that funds be provided to cover the additional expenditures that the commission's recommendations would require.