Abstract
BackgroundResearch 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.MethodsBetween 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.ResultsThe 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.ConclusionsEffectively 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.
Highlights
Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared
What is it important to know about data sharing? The majority of clinical trial participants interviewed were of the opinion that as long as data sharing had potential benefits to society and they would not be harmed or inconvenienced by such sharing they were happy to consent to it
We found that the words “data”, “sharing” and “data sharing”, as we understand them in this context, and as they were translated into Thai, were not immediately understood by the clinical trial participants, and as a consequence they exhibited a wide range of interpretations of data sharing
Summary
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. Regulatory agencies, and journals are increasingly expecting that individual-level data obtained from health research will be shared more widely [1,2,3,4]. To date there have been few empirical investigations into best practices in seeking broad consent for data sharing in LMICs, including considerations of how much information to provide to research participants and how best to explain concepts comprehensibly. The experience of others conducting research in LMICs shows that research participants often do not comprehend some aspects of research, including abstract and unfamiliar concepts [15,16,17,18]
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