Pace Christine, Grady Christine, Wendler David, Bebchuk Judith D, Tavel Jorge A, McNay Laura A, Forster Heidi P, Killen Jack, Emanuel Ezekiel J
Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Mayland 20892, USA.
AIDS Res Hum Retroviruses. 2006 Sep;22(9):837-41. doi: 10.1089/aid.2006.22.837.
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.
关于在试验结束后提供经研究证明有效的产品这一伦理要求存在争议。对于几个利益相关者的观点知之甚少。在一项多国艾滋病病毒试验中，65名机构审查委员会/伦理审查委员会主席、117名研究人员和500名研究参与者完成了电话或自行填写的问卷，以评估他们对试验后获取在研究中被证明有效的干预措施的看法。共有83%的研究参与者、29%的机构审查委员会/伦理审查委员会主席和42%的研究人员（p = 0.046）认为，如果白细胞介素-2被证明有效，应该为世界上每一位感染艾滋病病毒的人提供。大多数欧洲和拉丁美洲的研究参与者认为白细胞介素-2应该免费提供，而北美、澳大利亚和泰国的参与者通常表示应以普通人能够承受的价格提供（p < 0.001）。大多数机构审查委员会/伦理审查委员会主席和研究人员认为，国际医学科学组织理事会的“合理可及性”要求适用于开展研究所在国家的人群，这意味着一种药物应以普通人能够承受的价格提供，并且东道国政府负有提供该药物的主要责任。大多数研究参与者认为，在研究中被证明有效的艾滋病药物应该提供给世界上每一个有需要的人。机构审查委员会/伦理审查委员会主席和研究人员在认为应该保障药物的对象以及保障方式上则没有那么宽泛。
