title: Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials.
abstract: American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of "respect for persons," which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the "respect for persons" principle.
authors: Ruqaiijah A. Yearby, J.D., M.P.H., is the Associate Dean of Institutional Diversity and Inclusiveness, Professor of Law, Oliver C. Schroeder Jr. Distinguished Research Scholar, and Associate Director of the Law-Medicine Center at Case Western Reserve University School of Law.
authors: Ruqaiijah A
authors: RA
authors: Yearby
mesh_terms: D001675:Bioethics; D006297:Health Services Accessibility; D006801:Humans; D007258:Informed Consent; D008913:Minority Groups; D012108:Research Personnel