Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey.
Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey.
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DOI：
10.1177/1740774512443594
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发表时间：
2012-06
期刊：
影响因子：
--
通讯作者：
Sugarman J
中科院分区：
文献类型：
--
作者：
Cohen MS;McCauley M;Sugarman J
获得确定使用抗逆转录病毒治疗（ART）以减少异性伴侣中艾滋病毒性传播的安全性和有效性所需的确切数据遇到了一系列道德挑战，这些挑战可能会危及HPTN 052，这是一项解决这一问题的多国临床试验，具有深远的公共卫生影响。描述和分析HPTN 052面临的主要伦理挑战。主要研究者、主要协调员和从事试验的伦理学家对伦理问题和针对这些问题对HPTN 052进行的修改进行了编目。然后描述和分析了试验特有的主要伦理问题，适当参考了已发表的文献和新的指南和政策。在许多临床试验中必须解决的伦理挑战，例如与获得知情同意和提供辅助护理有关的挑战，没有描述。在设计HPTN 052时，出现了与研究问题本身的相关性有关的伦理问题，这些问题来自观察性研究的数据以及关于预防和治疗艾滋病毒感染和艾滋病的适当方法的一系列信念。此外，由于科学上需要在艾滋病毒发病率高的环境中进行研究，因此在选址方面面临伦理挑战，但应提供参与研究的替代方案。在大多数艾滋病毒预防研究中，伦理问题围绕着为所有参与者确定适当的预防方案。在试验过程中，出现了与研究问题直接相关的指导文件和政策，要求平衡对研究受试者和试验完整性的关注。在研究结果公布后，有必要确保人们能够获得被证明有效的治疗，在某些情况下，这种治疗与研究地点使用的指导方针不同。此外，还提出了关于是否有义务通知受试者“无关联”艾滋病毒传播的问题，即在参加研究的指定性伴侣之外获得的感染。所描述的伦理问题仅限于作者发现的问题，而不是其他利益相关者可能发现的其他问题或在分析这些问题时有不同的观点。了解HPTN 052所面临的伦理挑战有望为未来复杂的长期临床试验的设计和实施提供信息，这些临床试验旨在解决关键的科学和公共卫生问题，其中数据和实践模式在试验过程中出现。
Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HPTN 052, the multinational clinical trial addressing this issue that has profound public health implications. To describe and analyze the major ethical challenges faced in HPTN 052. The ethical issues and modifications of HPTN 052 in response to these issues were catalogued by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed, referring as appropriate to published literature and emerging guidance and policies. Ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described. When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV-infection and AIDS. Further, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines used at the sites where the research was being conducted. In addition, questions were raised about whether there was an obligation to notify subjects about “unlinked’ transmissions of HIV, that is, infections acquired outside of the designated sexual partners enrolled in the study. The ethical issues described are limited to those discerned by the authors and not those of other stakeholders who may have identified additional issues or had a different perspective in analyzing them. Understanding the ethical challenges faced in HPTN 052 promises to inform the design and conduct of future complex, long-term clinical trials aimed at addressing critical scientific and public health questions, where data and practice patterns emerge over the course of the trial.
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HAART启动和人类免疫缺陷病毒1型血清抗体的时机。
影响因子：
--
作者：
Funk, Michele Jonsson;Fusco, Jennifer S.;Cole, Stephen R.;Thomas, James C.;Porter, Kholoud;Kaufman, Jay S.;Davidian, Marie;White, Alice D.;Hartmann, Katherine E.;Eron, Joseph J., Jr.
通讯作者：
Eron, Joseph J., Jr.
影响因子：
3.3
作者：
Hawkins, JS;Emanuel, EJ
通讯作者：
Emanuel, EJ
DOI：
10.1136/bmj.c2205
发表时间：
2010-05-14
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Del Romero J;Castilla J;Hernando V;Rodríguez C;García S
通讯作者：
García S
影响因子：
3.3
作者：
Miller, FG;Brody, H
通讯作者：
Brody, H
影响因子：
2.1
作者：
Emanuel, EJ
通讯作者：
Emanuel, EJ