Gilbertson Adam, Kelly Elizabeth Poole, Rennie Stuart, Henderson Gail, Kuruc JoAnn, Tucker Joseph D
1 Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
2 UNC Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
AIDS Res Hum Retroviruses. 2019 Jan;35(1):100-107. doi: 10.1089/AID.2017.0224. Epub 2018 Aug 22.
Currently, much of early phase HIV cure research involves unknown and potentially serious risks, with little or no chance of direct health benefits. During informed consent, researchers emphasize this lack of personal medical benefit to minimize misconceptions that undermine genuine consent. We explored participants' and researchers' perspectives on HIV cure clinical research participation and its potential benefits. We conducted semistructured interviews with 17 HIV cure research participants and nine researchers in North Carolina, USA. We analyzed interviews to identify participant experience-related themes. We were particularly interested in indirect benefits, such as psychological support or improved care. We also assessed five consent documents for benefit/risk-related language. Research participants were male, with a median age of 50 (range: 28-62); most were non-Hispanic white (15/17) and men who have sex with men (13/17). All 17 trial participants found research participation meaningful and beneficial. Reported benefits included improved healthcare (16/17), HIV knowledge (13/17), intimate relationships (10/17), and positive behaviors (6/17). In addition, all participants described psychological benefits, including increased positive outlook, improved sense of purpose, emotional support, and enriched self-image. Participants reported risks such as quality of life concerns, uncomfortable procedures (e.g., leukapheresis), latency reversal, and HIV status disclosure. While the consent documents included discussion of these and other risks, they did not mention potential indirect benefits. Individuals involved in HIV clinical research have recognized participant psychological, social, and behavioral benefits. We recommend that researchers and institutional review boards consider these benefits for inclusion during risk/benefit assessments, consent procedures, and other discussions with prospective participants.
目前，许多早期阶段的艾滋病治愈研究涉及未知且可能严重的风险，几乎没有或完全没有直接的健康益处。在知情同意过程中，研究人员强调缺乏个人医疗益处，以尽量减少破坏真正同意的误解。我们探讨了参与者和研究人员对艾滋病治愈临床研究参与及其潜在益处的看法。我们在美国北卡罗来纳州对17名艾滋病治愈研究参与者和9名研究人员进行了半结构化访谈。我们分析访谈以确定与参与者经历相关的主题。我们特别关注间接益处，如心理支持或改善护理。我们还评估了五份关于益处/风险相关语言的同意文件。研究参与者为男性，中位年龄为50岁（范围：28 - 62岁）；大多数是非西班牙裔白人（15/17）以及男同性恋者（13/17）。所有17名试验参与者都认为参与研究有意义且有益。报告的益处包括改善医疗保健（16/17）、艾滋病知识（13/17）、亲密关系（10/17）以及积极行为（6/17）。此外，所有参与者都描述了心理益处，包括更积极的人生观、更强的目标感、情感支持以及丰富的自我形象。参与者报告了诸如生活质量担忧、不舒服的程序（如白细胞分离术）、潜伏期逆转以及艾滋病病毒状态披露等风险。虽然同意文件包括了对这些及其他风险的讨论，但它们没有提及潜在的间接益处。参与艾滋病临床研究的人员已经认识到参与者的心理、社会和行为益处。我们建议研究人员和机构审查委员会在风险/益处评估、同意程序以及与潜在参与者的其他讨论中考虑纳入这些益处。
