背景:在美国和其他地方,针对艾滋病毒治愈的生物医学研究正在推进,然而,对潜在研究参与者和其他利益相关者对风险和收益的看法知之甚少。我们进行了一项定性研究,以探索在HIV感染者(PLWHIV)中进行的实验性HIV治愈研究的感知风险和收益。生物医学HIV治疗研究人员,政策制定者和生物伦理学家。
方法:我们对PLWHIV的目的样本进行了深入访谈,进行了定性研究。生物医学HIV治疗研究人员,2015-2016年的政策制定者和生物伦理学家。我们使用扎根理论的主题分析来分析访谈笔录。
结果:我们进行并分析了36个关键的线人访谈。定性分析揭示了四个主要发现。1)潜在的HIV治愈研究志愿者指出,需要更多关于HIV治愈研究的潜在风险的信息和教育。2)生物医学HIV治疗研究人员,政策制定者和生物伦理学家对艾滋病毒治疗研究的社会和财务风险的认识低于PLWHIV。3)大多数受访者在不同类别的线人中发现了一些风险,这些风险在HIV治愈研究中无法接受,尽管PLWHIV的一个子集没有对可接受的风险设定上限.4)与其他利益相关者相比,PLWHIV对参与HIV治愈研究的潜在心理益处有更好的认识。
结论:我们的研究表明,PLWHIV对个体风险有不同的理解,有时是实质性的,参与生物医学HIV治愈研究。社区参与和提高研究素养可能有助于提高社区理解。严格的知情同意程序对于实施伦理研究是必要的。艾滋病毒治疗研究的现状为社会提供了比参与者更大的潜在利益。监管机构之间可能存在分歧,研究人员,临床医生,以及潜在参与者关于什么构成HIV治愈研究的可接受风险。
BACKGROUND: Biomedical research towards an HIV cure is advancing in the United States and elsewhere, yet little is known about perceptions of risks and benefits among potential study participants and other stakeholders. We conducted a qualitative study to explore perceived risks and benefits of investigational HIV cure research among people living with HIV (PLWHIV), biomedical HIV cure researchers, policy-makers and bioethicists.
METHODS: We conducted a qualitative research study using in-depth interviews with a purposive sample of PLWHIV, biomedical HIV cure researchers, policy-makers and bioethicists in 2015-2016. We analysed interview transcripts using thematic analysis anchored in grounded theory.
RESULTS: We conducted and analyzed 36 key informant interviews. Qualitative analysis revealed four main findings. 1) Potential HIV cure study volunteers noted needing more information and education about the potential risks of HIV cure research. 2) Biomedical HIV cure researchers, policy-makers and bioethicists showed less awareness of social and financial risks of HIV cure research than PLWHIV. 3) Most respondents across the different categories of informants identified some risks that were too great to be acceptable in HIV cure research, although a subset of PLWHIV did not place an upper limit on acceptable risk. 4) PLWHIV showed a better awareness of potential psychological benefits of participating in HIV cure research than other groups of stakeholders.
CONCLUSIONS: Our research suggests that PLWHIV have a variable understanding of the individual risks, sometimes substantial, associated with participating in biomedical HIV cure research studies. Community engagement and increased research literacy may help improve community understanding. Intensive informed consent procedures will be necessary for ethical study implementation. The current state of HIV cure research offers greater potential benefits to society than to participants. There is likely to be disagreement among regulators, researchers, clinicians, and potential participants about what constitutes acceptable risk for HIV cure studies.