Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok, Thailand.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, UK.
BMC Med Ethics. 2020 Feb 3;21(1):12. doi: 10.1186/s12910-020-0453-z.
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.
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.
In this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them.
共享去识别化的个体健康研究数据被广泛提倡，具有许多潜在的益处。然而，也存在一些潜在的危害，如数据滥用和违反参与者的保密性。通过采用管理访问方法，可以在促进数据共享的同时减轻其潜在危害，即将数据请求通过数据访问委员会（DAC）进行引导，而不是无限制地公开提供数据。DAC 无论是由个人组成的正式或非正式团体，都有责任审查和评估数据访问请求。许多独立的、机构的、联盟的 DAC 已经建立，但目前还没有广泛接受的组织和功能框架。
我们建议 DAC 应该扮演促进数据共享和保护数据主体、其社区、数据生产者、其机构和科学事业的角色。我们认为，只要数据再利用具有潜在的社会价值，并且可以预见的危害风险较低，DAC 就应该授予数据访问权限。为了促进数据共享并激励数据生产者，DAC 应该鼓励符合数据生产者及其自身机构利益的数据的二次使用。鉴于 DAC 的建议角色，应该有透明、简单和明确的数据访问申请程序。审查申请的方法应与所涉风险成比例。DAC 应在具有明确问责制、职权范围和成员资格的机构和法律框架内设立。我们建议，DAC 不应仿照研究伦理委员会（RECs）设立，因为它们的审查职能和目标与 RECs 不同。DAC 审查应遵循公共卫生伦理原则，而不是研究伦理原则。
在本文中，我们提出了 DAC 应该运作的框架，如何组织它们，以及如何构成它们。
