title: Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study.
abstract: Controversy exists regarding an ethical requirement to make products proven effective in research available after the trial. Little is known about the views of several stakeholders. Phone or self-administered questionnaires were completed by 65 IRB/REC chairs, 117 investigators, and 500 research participants in a multinational HIV trial to assess their views about posttrial access to interventions proven effective in the study. A total of 83% of research participants, 29% of IRB/REC chairs, and 42% of researchers (p = 0.046) thought IL-2 should be guaranteed for every HIV-infected person in the world if proven effective. Most European and Latin American research participants thought IL-2 should be provided free, while North American, Australian, and Thai participants commonly said at a price the average person could afford (p < 0.001). Most IRB/REC chairs and researchers thought the CIOMS "reasonable availability" requirement applied to people in the country where the study was conducted and meant a drug should be available at a price the average person could afford and that host country governments had primary responsibility for making it available. Most research participants believe an HIV drug proven effective in research should be made available to everyone in the world who needs it. IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed.
authors.affiliation: Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Mayland 20892, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Pace
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
authors.forename: David
authors.initials: D
authors.lastname: Wendler
authors.forename: Judith D
authors.initials: JD
authors.lastname: Bebchuk
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Tavel
authors.forename: Laura A
authors.initials: LA
authors.lastname: McNay
authors.forename: Heidi P
authors.initials: HP
authors.lastname: Forster
authors.forename: Jack
authors.initials: J
authors.lastname: Killen
authors.forename: Ezekiel J
authors.initials: EJ
authors.lastname: Emanuel
mesh_terms: D000328:Adult; D026683:Advisory Committees; D000368:Aged; D019380:Anti-HIV Agents / Q000191:economics / Q000600:supply & distribution* / Q000627:therapeutic use; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000941:ethics / Q000706:statistics & numerical data; D003625:Data Collection; D016527:Drug Costs; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006291:Health Policy; D006297:Health Services Accessibility / Q000941:ethics*; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011639:Public Opinion; D012108:Research Personnel; D035842:Research Subjects; D011795:Surveys and Questionnaires
chemical_list: D019380:Anti-HIV Agents; D007376:Interleukin-2