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并行却相互关联:在面临伦理挑战的HIV缓解试验中开展行为与社会科学研究的细微差别

Parallel but connected: Nuances of conducting behavioral and social science research alongside ethically challenging HIV remission trials.

作者信息

Henderson Gail E, Rennie Stuart, Corneli Amy, Meagher Karen, Cadigan R Jean, Kroon Eugène, Ananworanich Jintanat, Peay Holly L

机构信息

Department of Social Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.

Departments of Population Health Sciences and Medicine, Duke University, Durham, NC, USA.

出版信息

Contemp Clin Trials Commun. 2020 Jun 16;19:100594. doi: 10.1016/j.conctc.2020.100594. eCollection 2020 Sep.

Abstract

Collaborations between clinical investigators and behavioral and social science researchers (BSSR) produce many benefits, but also may generate challenges and complexities. Ongoing relationships between teams may affect the research carried out by the BSSR team and the way they interpret their findings. Here we describe our experiences conducting the HIV Remission ('Cure') Trials Decision-Making Study (DMS), in Thailand; these trials include potentially risky interventions and interruption of standard antiretroviral treatment, with little personal benefit. The DMS is a longitudinal study of the experiences of individuals recruited to such early-phase trials, and conducted alongside these trials. It originated in clinical investigators' concerns about the ability of those recruited to make voluntary and informed decisions about scientifically complex studies, and is led by an independent group of BSSR and ethics researchers. In conducting this study, we experienced three overarching challenges to achieving a successful and dynamic collaboration: managing emerging findings as data were collected alongside clinical trial participation; evolving interconnectedness and shifting partnership boundaries among investigators; and the process of incorporating new research questions. By describing these challenges, we provide experiential evidence on how to manage multidimensional aspects of these collaborations. We describe how our research teams came together as well as the challenges and opportunities we experienced along the way. Our aim is to raise awareness of the scientific, practical, and ethical complexities of establishing and maintaining this kind of broad multidisciplinary collaboration over time. By describing our experiences, we hope to advance an agenda for others who undertake similar partnerships.

摘要

临床研究人员与行为和社会科学研究人员(BSSR)之间的合作带来了诸多益处,但也可能产生挑战和复杂性。团队之间的持续关系可能会影响BSSR团队开展的研究以及他们对研究结果的解读方式。在此,我们描述我们在泰国开展艾滋病缓解(“治愈”)试验决策研究(DMS)的经历;这些试验包括潜在的风险干预以及中断标准抗逆转录病毒治疗,且个人受益甚微。DMS是一项对招募到此类早期试验的个体经历进行的纵向研究,并与这些试验同步进行。它源于临床研究人员对被招募者就科学复杂研究做出自愿且知情决策能力的担忧,由一组独立的BSSR和伦理研究人员牵头。在开展这项研究过程中,我们在实现成功且充满活力的合作方面遇到了三个总体挑战:在临床试验参与过程中收集数据时管理新出现的研究结果;研究人员之间不断变化的相互联系以及合作伙伴边界的转移;以及纳入新研究问题的过程。通过描述这些挑战,我们提供了关于如何管理这些合作多维度方面的经验证据。我们描述了我们的研究团队是如何走到一起的,以及我们在此过程中经历的挑战和机遇。我们的目标是提高人们对随着时间推移建立和维持这种广泛多学科合作所涉及的科学、实践和伦理复杂性的认识。通过描述我们的经历,我们希望为其他开展类似合作的人推进一项议程。

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