Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda

Cheah, Phaik Yeong; Npj., Day; Parker, Michael; Bull, Susan

doi:10.1007/s41649-017-0029-5

Cited by 8 publications

(14 citation statements)

References 12 publications

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“… 7 Other studies in LMICs have stressed the importance of capacity building and investment in data management and data science skills, as well as in data-sharing platforms. 27 , 29 , 40 In the present study, the researchers may not have been widely aware of the requirement for data-sharing or prepared the resources necessary to do so, or did not fully comprehend what data-sharing entails. This could be one barrier inhibiting data-sharing in Thailand and possibly other LMICs.…”

Section: Discussionmentioning

confidence: 94%

“…5,37–39 However, an empirical study showed that providing information on data-sharing and obtaining broad consent for data-sharing, in addition to consent for the primary study, made the consent process more complex and difficult to comprehend by the study participants, particularly when the study was conducted in rural areas of LMICs. 40 A qualitative study among stakeholders of a research unit based in Thailand demonstrated that clinical-trial participants mainly focused on information about the potential benefits and harms of data-sharing and how much information should be provided about data-sharing. 28 It is important to have effective, valid, consent process.…”

Section: Discussionmentioning

confidence: 99%

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Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand

Kaewkungwal

Adams

Sattabongkot

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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. Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This study examined the views of researchers in a middle-income country, Thailand, regarding the most important data-sharing challenges. The target researchers worked in biomedical and related research. The survey was distributed to 38 academic and health-science institutes, 18 university hospitals, 84 nonuniversity hospitals, and 22 research institutes across Thailand; 229 researchers in clinical/basic and social/behavioral sciences, and pubxxlic health/policy participated. Thai researchers were less concerned with informed consent and the feasibility of conducting research and sharing data, focusing on the importance of safeguards when handling data, including transfer to others, and possible lack of control over subsequent data use. The respondents felt that researchers should decide what types of project data are shareable and which data are likely useful to the scientific community. They were more concerned with appropriate acknowledgment and protecting the legal rights of the primary data collectors and providers. Although they had concerns about data access conditions, they rated sharing sufficient data and metadata to reproduce the analysis of the primary outcomes as highly important. These results are important for future efforts of the LMIC countries to develop efficient data-sharing frameworks and establish institutional data access committees. They highlight the importance, for the sustainability and fairness of these efforts, to ensure that parties in LMIC countries receive appropriate credit and are involved in determining where/when/how their data may be used.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand

Kaewkungwal

Adams

Sattabongkot

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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“…This study examined perspectives about how best to seek broad consent to data sharing at MORU, which implemented a data sharing policy and the use of broad consent in January 2016 [ 23 , 24 ]. To date there are very few empirical accounts on the challenges of seeking broad consent in low- and middle-income settings, the majority of previous studies have been conducted in the context of genomic and biobanking research and in high-income settings [ 14 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

“…It has been MORU’s policy for many years to support sharing of data across collaborative research networks and more widely to maximize its research impact. In order to formalize the process of data sharing, in January 2016, MORU established a data sharing policy in which requests for data are channeled through a Data Access Committee (DAC) and discussed with the senior investigators of the relevant studies [ 22 – 24 ]. The MORU data sharing policy was informed by a collaborative study into best practices in sharing individual level data generated in LMICs in 2014–2015 [ 13 , 14 ].…”

Section: Methodsmentioning

confidence: 99%

Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand

et al. 2018

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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.

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“…Our normative proposal is supported by experience of establishing and coordinating the Mahidol Oxford Tropical Medicine Research Unit (MORU) DAC, which has reviewed over 40 applications since its establishment in January 2016 [51][52][53]. The MORU DAC has reviewed many types of data requests including data in real time from an ongoing clinical study, from historical trials done without participant consent for data sharing, and from pharmaceutical companies for data from trials conducted in low-resource settings for registering products in developed countries [52,54].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Data Access Committees

Cheah

Piasecki

2020

BMC Med Ethics

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Background: Sharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function. Main text: We propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics. Conclusions: In this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them.

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Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda

Cited by 8 publications

References 12 publications

Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand

Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand

Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand

Data Access Committees

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