Pratt Bridget, Zion Deborah, Lwin Khin Maung, Cheah Phaik Yeong, Nosten Francois, Loff Bebe
Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe St,, Baltimore, MD 21205, USA.
BMC Med Ethics. 2014 Jun 26;15:49. doi: 10.1186/1472-6939-15-49.
In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
Case study research was undertaken on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial, which was performed on the Thai-Myanmar border with Karen and Myanmar refugees and migrants. We conducted nineteen in-depth interviews with trial stakeholders, including investigators, trial participants, community advisory board members, and funder representatives; directly observed at trial sites over a five-week period; and collected trial-related documents for analysis.
The vivax malaria treatment trial drew attention to contextual features that, when present, rendered the 'research for health justice' framework's guidance partially incomplete. These insights allowed us to extend the framework to consider external research actors' obligations to stateless populations. Data analysis then showed that framework requirements are largely fulfilled in relation to the vivax malaria treatment trial by Wellcome Trust (funder), Oxford University (sponsor), and investigators. At the same time, this study demonstrates that it may be difficult for long-term collaborations to shift the focus of their research agendas in accordance with the changing burden of illness in their host communities and to build the independent research capacity of host populations when working with refugees and migrants. Obstructive factors included the research funding environment and staff turnover due to resettlement or migration.
Our findings show that obligations for selecting research targets, research capacity strengthening, and post-trial benefits that link clinical trials to justice in global health can be upheld by external research actors from high-income countries when working with stateless populations in LMICs. However, meeting certain framework requirements for long-term collaborations may not be entirely feasible.
为响应扩大研究伦理范围以解决全球健康领域正义问题的呼吁，近期的学术研究试图阐明高收入国家的外部研究行为体如何履行其减少国家间和国家内部健康差距的义务。一个伦理框架——“健康正义研究”——源自一种正义理论（健康能力范式），并具体规定了国际临床研究如何有助于改善东道社区的健康状况和研究能力。本文探讨外部资助者、主办方和研究人员是否以及如何能够履行该框架下的义务。
对设在泰国 - 缅甸边境针对克伦族以及缅甸难民和移民开展间日疟治疗试验的肖洛疟疾研究单位（SMRU）进行了案例研究。我们对试验利益相关者进行了19次深入访谈，包括研究人员、试验参与者、社区咨询委员会成员和资助者代表；在为期五周的时间里直接观察了试验地点；并收集了与试验相关的文件进行分析。
间日疟治疗试验凸显了一些背景特征，这些特征一旦出现，就会使“健康正义研究”框架的指导部分不完整。这些见解使我们能够扩展该框架，以考虑外部研究行为体对无国籍人群的义务。数据分析随后表明，威康信托基金会（资助者）、牛津大学（主办方）和研究人员在间日疟治疗试验方面基本履行了框架要求。与此同时，本研究表明，长期合作可能难以根据东道社区不断变化的疾病负担转移其研究议程重点，并且在与难民和移民合作时难以建立东道人群的独立研究能力。阻碍因素包括研究资金环境以及因重新安置或移民导致的人员流动。
我们的研究结果表明，高收入国家的外部研究行为体在与低收入和中等收入国家的无国籍人群合作时，可以履行在选择研究目标、加强研究能力以及将临床试验与全球健康正义相联系的试验后获益等方面的义务。然而，满足长期合作的某些框架要求可能并不完全可行。
