Department of Bioethics and Health Professionalism, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.
Department of Behavioral Sciences, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.
BMC Med Ethics. 2024 May 14;25(1):54. doi: 10.1186/s12910-024-01058-4.
A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case.
The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software.
The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research.
In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.
制定一个道德合理的利益共享框架对于减少发展中国家开展的研究中的研究剥削至关重要。然而，在实践中，对于哪些利益相关者应该参与关于利益共享的决策过程以及可能产生的影响仍然存在不确定性。因此，本研究旨在以艾滋病毒疫苗试验为例，通过实证提出研究中利益共享谈判的框架。
本研究在坦桑尼亚进行，采用案例研究设计和定性方法。使用深入访谈（IDI）和焦点小组讨论（FGD）收集数据。总共选择了 37 名研究参与者，包括机构审查委员会（IRB）成员、研究人员、社区咨询委员会（CAB）成员、政策制定者和艾滋病毒/艾滋病倡导者。采用演绎和归纳主题分析方法，借助 MAXQDA 版本 20.4.0 软件分析收集的数据。
研究结果表明，研究社区、研究社区和中介机构之间存在三角关系。然而，这种关系应该考虑到谈判的时间、各方的理解程度以及临床试验的阶段。拟议的框架使基于社区的参与式研究中的伙伴关系互动具有操作性。
在本研究的背景下，建议的框架纳入了研究社区、被研究社区和中介方。该框架将确保在艾滋病毒疫苗试验和在资源有限环境中进行的其他健康相关研究中就利益共享进行知情和包容的决策。
