title: Formal assessment of voluntariness with a three-part consent process.
abstract: Informed consent that is voluntary and made by an individual who is knowledgeable and competent is a foundational requirement for protecting human subjects from harm and exploitation that could result from research participation. In 1974 Miller and Willner proposed a two-part consent process that involved disclosure of information and assessment of comprehension. The authors propose a brief third component to the consent process: assessment of voluntariness. Three steps are involved: generate a list of potential coercive influences on the basis of the research population and the study context, develop a set of questions to assess the presence and intensity of the impact of these influences, and identify alternative courses of action should coercion be identified.
authors.affiliation: Department of Mental Health Law and Policy, University of South Florida, 13301 Bruce B. Downs Blvd., Tampa, FL 33612, USA. stiles@fmhi.usf.edu
authors.forename: Paul G
authors.initials: PG
authors.lastname: Stiles
authors.forename: Monica K
authors.initials: MK
authors.lastname: Epstein
authors.forename: Norman G
authors.initials: NG
authors.lastname: Poythress
authors.forename: John F
authors.initials: JF
authors.lastname: Edens
mesh_terms: D032882:Comprehension; D030881:Disclosure; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008962:Models, Theoretical; D018579:Patient Selection / Q000941:ethics*; D035842:Research Subjects; D014481:United States