title: Clinical research with healthy volunteers: an ethical framework.
abstract: Clinical research involving healthy volunteers is important for advancing medical knowledge but raises a variety of ethical issues, many of which stem from the fact that such studies pose risks to research participants without the prospect of medical benefits to them. Ethical issues in research with healthy volunteers are identified and analyzed with the help of an ethical framework consisting of seven ethical requirements for clinical research. These ethical requirements include (1) scientific or social value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-to-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects.
authors.affiliation: Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation / Q000941:ethics*; D018579:Patient Selection; D035842:Research Subjects; D018570:Risk Assessment