Informed Consent in Psychiatric Research: Preliminary Findings From an Ongoing Investigation

Abstract

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. (KIE abstract)