title: Enrolling the uninsured in clinical trials: an ethical perspective.
abstract: Research participation by individuals who lack health insurance raises significant but seldom-discussed ethical issues for clinical investigators. Of particular concern are the possibility that their lack of options for getting care at the time of enrollment makes the uninsured susceptible to undue inducement to join trials and the possibility that their inability to access research products after trials leads to their exploitation. In tension with these concerns, however, is the right of the uninsured to fair consideration for research participation. We discuss these competing issues and make recommendations for how investigators can both protect uninsured research participants and provide the uninsured with fair access to research in their recruitment and enrollment strategies.
authors.affiliation: Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. cpace@cc.nih.gov
authors.forename: Christine
authors.initials: C
authors.lastname: Pace
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
authors.forename: Marion
authors.initials: M
authors.lastname: Danis
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D032984:Ethics, Research; D006297:Health Services Accessibility; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D017057:Medically Uninsured; D018579:Patient Selection / Q000941:ethics*; D014481:United States; D035862:Vulnerable Populations