title: The potential exploitation of research participants in high income countries who lack access to health care.
abstract: There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low- and middle-income countries are not exploited are unlikely to protect participants in high-income countries. The present manuscript argues that one way to address concerns about exploitation in high-income countries would be to require sponsors to provide targeted benefits such as medical treatment during the trial, or the study drug after the trial. The latter could be achieved through extension studies, expanded access programs, or named-patient programs. Sponsors also might provide non-medical benefits, such as education or social support. Ethical and regulatory guidance should be revised to ensure that research participants in high-income countries who lack access to healthcare services receive sufficient benefits.
authors.affiliation: Clinical Research, BUC (Biosciences UAM + CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, Madrid, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
authors.affiliation: Department of Social Science, Health and Medicine, King's College, London, UK.
authors.forename: Annette
authors.initials: A
authors.lastname: Rid
authors.affiliation: Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania,, USA.
authors.forename: Ezekiel
authors.initials: E
authors.lastname: Emanuel
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
authors.forename: David
authors.initials: D
authors.lastname: Wendler
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence; D019049:Developed Countries; D003906:Developing Countries; D033161:Government Regulation; D006297:Health Services Accessibility / Q000191:economics / Q000941:ethics*; D006801:Humans; D007182:Income; D007258:Informed Consent; D018579:Patient Selection / Q000941:ethics*; D011203:Poverty / Q000941:ethics*
keywords: clinical trials regulation; drug development; ethical trial conduct; exploitation of participants; fair benefits framework; poor trial participants