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

Cheah, Phaik Yeong; Jatupornpimol, Nattapat; Hanboonkunupakarn, Borimas; Khirikoekkong, Napat; Jittamala, Podjanee; Pukrittayakamee, Sasithon; Npj., Day; Parker, Michael; Bull, Susan

doi:10.1186/s12910-018-0326-x

Cited by 22 publications

(32 citation statements)

References 36 publications

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“…Broad consent could be valid if there was some clarity at the time of consent, the kinds of people, or institutions to be shared with, and how, in broad terms, the data would likely be used. 28 , 29 In this study, only about half of the researchers rated the use of broad consent in acquiring data for sharing as very important. It is postulated that many researchers might have usually applied broad consent in their studies.…”

Section: Discussionmentioning

confidence: 81%

“… 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. Broad consent could be valid if there was some clarity at the time of consent, the kinds of people, or institutions to be shared with, and how, in broad terms, the data would likely be used.…”

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: 81%

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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“…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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“…However, from our experience and that of others conducting studies in LMICs, participants rarely fully comprehend the information in primary studies [22–24]. Our recent empirical study showed that providing information on data sharing and obtaining broad consent for data sharing in addition to the consent for the primary study adds another layer of complexity to the consent process [25].…”

Section: Elements Of a Data Management And Sharing Policymentioning

confidence: 99%

Data management and sharing policy: the first step towards promoting data sharing

Waithira

Mutinda

Cheah

2019

BMC Med

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Background Health-related research funders, regulators and journals expect that de-identified individual-level health data be shared widely, with as few restrictions as possible; yet, in reality, the volume of shared data remains low. Main body Health researchers and other data producers are reluctant to share their data unless they are confident that their datasets are of high quality and reliable, and that they are used in accordance with the values and aims of their institutions. We argue that having an institutional, departmental or group data management and sharing policy is the first step towards encouraging researchers and healthcare professionals to share their data more widely. Our paper outlines the elements of a data management and sharing policy, which should include aims consistent with those of the institution as well as with data management procedures, models of data sharing, request procedures, consent models and cost recovery mechanisms. A policy would help an institution, department or group maximise the use of its data and protect the interests of the institution and its members. We base our recommendations on our experience collecting and curating data for large clinical trials conducted in low- and middle-income countries, facilitating the sharing of datasets with secondary users, whilst teaching data management and conducting empirical research on data sharing. Although the fundamentals of a policy are general, the paper is focused on the low- and middle-income country context. Conclusion We argue that having an institutional, departmental or group data management and sharing policy is the first step in promoting data sharing.

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

Cited by 22 publications

References 36 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

Data Access Committees

Data management and sharing policy: the first step towards promoting data sharing

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