Cheah Phaik Yeong, Jatupornpimol Nattapat, Hanboonkunupakarn Borimas, Khirikoekkong Napat, Jittamala Podjanee, Pukrittayakamee Sasithon, Day Nicholas P J, Parker Michael, Bull Susan
Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK.
BMC Med Ethics. 2018 Nov 7;19(1):86. doi: 10.1186/s12910-018-0326-x.
Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent to data sharing in January 2016.
Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing.
The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders' perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context.
Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants' understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing.
研究资助者、监管机构和期刊越来越期望分享健康研究中的个体层面数据。在低收入和中等收入环境中，对这种数据分享给予广泛同意被认为是合适、可行且可接受的，但迄今为止，为指导此类流程设计而开展的实证研究有限。我们研究了利益相关者对于如何最好地寻求广泛同意以分享玛希隆牛津热带医学研究中心的数据的看法，该中心于2016年1月实施了数据分享政策并对数据分享给予广泛同意。
2017年2月至8月期间，在曼谷和泰缅边境城镇美索两个地点收集了定性数据。我们进行了18次半结构化访谈。我们还进行了4次焦点小组讨论，共有19人参与。描述性和主题编码为分析数据分享的各个方面提供了信息，这些方面被认为对于让参与者了解数据分享以及解释与数据分享相关的复杂和抽象主题的最佳方式最为重要。
研究结果表明，临床试验参与者将数据分享的潜在益处和危害信息列为优先事项。利益相关者就如何澄清在此类主题上提供的数据分享信息提出了多项建议。利益相关者对于应提供多少数据分享信息的看法存在显著差异，而且很明显，有效的信息提供应针对研究、研究人群、个体研究参与者和研究背景做出回应。
在实践中，与研究参与者就数据分享进行有效沟通具有挑战性，这凸显了在此背景下健全且有效的数据分享治理的重要性。广泛同意应纳入对数据分享的有效且高效的解释，以促进明智的决策，同时不妨碍研究参与者对将从中分享数据的研究关键方面的理解。需要进一步开展工作，以完善向所有研究参与者提供的数据分享核心信息的制定，以及应对解释数据分享时出现的特定背景挑战的适当解决方案。
