Are research subjects really informed?
To determine how adequately patients who participate as subjects for clinical investigation understand their commitment, 50 patients admitted to the Clinical Research Center of the University of Washington were interviewed. Their responses were compared with the detailed statements in the consent forms for the 23 specific protocols under which they were being studied. In spite of careful controls in accord with guidelines of a review committee, only half the patients were able to describe accurately their expectations of the studies to which they had given signed consent.
D000293:Adolescent; D000328:Adult; D030881:Disclosure; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D012106:Research; D035842:Research Subjects; D018570:Risk Assessment; D014861:Washington