Preliminary findings from an investigation of informed consent processes in four psychiatric research projects (two being carried out at a university medical center and two at a public psychiatric hospital) are reported. Study methods include the systematic observation of investigator/subject information disclosure sessions using audio and videotape, as well as the use of standardized interaction rating forms and subject understanding interviews. In an attempt to determine if subjects' understanding of research can be improved through increased subject education, several modes of information disclosure are compared. Partial results from the public psychiatric hospital portion of the investigation suggest low subject understanding in many areas with subjects often demonstrating difficulty differentiating between treatment and biomedical research. Subjects' problematic understanding of research purposes and methodology was compounded by investigator disclosures which often emphasized the therapeutic, personalistic and nonresearch-oriented aspects of the project. Nevertheless, even when information disclosures were significantly improved, subject understanding in many cases continued to be low--suggesting that additional factors aside from the quality of investigator disclosure are involved in psychiatric subjects' comprehension and understanding of research. The implication of these findings for informed consent, regulation of biomedical research and the protection of human subjects are discussed.
KIE: Preliminary findings from a multi-institutional investigation of the informed consent process in drug studies with psychiatric patients are reported, and several modes of information disclosure are compared in an attempt to determine if subjects' understanding of research can be improved through increased education. Many prospective subjects were found to lack adequate understanding of the nature and purpose of the research in which they were asked to participate. The subjects' problematic understanding was compounded by investigator disclosures which often emphasized the therapeutic, personalistic, and nonresearch-oriented aspects of the project. Understanding often continued to be low, however, even when information disclosures were significantly improved, suggesting that additional factors are involved. The implications of these findings for informed consent and the regulation of human experimentation are discussed.