Original ArticlesVoluntariness of Consent for Research An Empirical and Conceptual ReviewNelson, Robert M. MD, PhD*; Merz, Jon F. MBA, JD, PhD† Author Information *From the Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania. †From the Department of Molecular and Cellular Engineering and Center for Bioethics, University of Pennsylvania, Philadelphia, Pennsylvania. Funded in part by grants from the National Institute of Neurologic Disorders and Stroke (KO1-NS02151, to R.M.N.) and from the National Institutes of Health, Department of Energy and the Veterans Administration Consortium on Informed Consent Research (RO1-HG-01765, to J.F.M.). Prepared for the March 2001 Veterans’ Administration Research and Development State-of-the-Art Conference Making Informed Consent Meaningful. Address correspondence and reprint requests to: Robert M. Nelson, MD, PhD, Department of Anesthesia/CCM, 9th Floor, The Children’s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104-4399. E-Mail: [email protected] Medical Care 40(9):p V-69-V-80, September 2002. Buy Abstract This article explores the vulnerability of research subjects either to undue influence or to coercion. The authors present a brief review of the requirement for voluntariness in research, and what is known about research participation. They then examine characteristics of potential subjects, researchers, researcher actions, and the research setting that can influence the voluntariness of subject’s decisions to participate. Throughout the paper, empirical work that relates to voluntariness is used to illustrate the conceptual material. Voluntariness is viewed as an issue of self-control. Threats to voluntariness can arise from vulnerabilities of potential subjects as well as from characteristics of the researcher, the researcher’s acts, and the research setting. Moral concerns about potential influences may be assessed by the likelihood that they will control or dominate a potential subject’s decision to participate in research. Policy responses may be appropriate where the probability of control is too high. © 2002 Lippincott Williams & Wilkins, Inc.