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June 2000

Evidence-Based Ethics and Informed Consent in Mental Illness Research

Arch Gen Psychiatry. 2000;57(6):540-542. doi:10-1001/pubs.Arch Gen Psychiatry-ISSN-0003-990x-57-6-ycm9491

SOME MEDICAL ethics questions are age-old and may be best understood through careful conceptual analysis and reflection. Some are not. Indeed, some ethics issues have emerged primarily as empirical questions of tremendous significance within modern biomedical science and clinical care. The current controversy surrounding the ethical acceptability of research involving people with mental illness serves as an important illustration of the way in which data may help to resolve contemporary moral questions. For instance, one argument against the participation of mentally ill individuals in research is the presumption that they are unable to make this choice freely and in a manner that appropriately weighs the personal risks of participation in relation to the potential benefits for themselves, science, and society.1 Recent data on the values, motivations, and risk assessments expressed by psychiatric patients may radically challenge these beliefs regarding their capacity for autonomy and altruism in the context of clinical investigation.2 Another argument offered against mental illness research pertains to the question of psychiatric patients' overall decisional capacity.3 Careful study of informed consent during the past 2 decades,46 including the work presented by Carpenter et al7 in this issue, has yielded compelling findings that bear directly on this issue of ethically sound research. Derived from elegant theoretical work over many generations, these "evidence-based" inquiries may thus offer practical responses to the pressing "applied" ethics questions we now face in medicine.

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