title: Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.
abstract: Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.
authors.affiliation: School of Applied Human Sciences, University of KwaZulu-Natal, South Africa.
authors.forename: Nicole
authors.initials: N
authors.lastname: Mamotte
authors.affiliation: School of Applied Human Sciences, University of KwaZulu-Natal, South Africa.
authors.forename: Douglas
authors.initials: D
authors.lastname: Wassenaar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002755:Choice Behavior; D002986:Clinical Trials as Topic / Q000941:ethics*; D003906:Developing Countries; D036262:Empirical Research; D005260:Female; D015658:HIV Infections; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D026684:Personal Autonomy; D010865:Pilot Projects; D012189:Retrospective Studies; D013019:South Africa; D036302:Therapeutic Human Experimentation
keywords: HIV research; informed consent; voluntariness