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.

中文翻译：

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数据访问委员会。

背景技术共享去标识化的个人级健康研究数据被广泛推广并具有许多潜在的好处。然而，也有一些潜在的危害，例如滥用数据和违反参与者机密。促进共享好处同时减轻其潜在危害的一种方法是采用管理访问方法，其中数据请求通过数据访问委员会 (DAC) 进行引导，而不是不受限制地公开提供数据。DAC，无论是正式的还是非正式的个人团体，都有责任审查和评估数据访问请求。许多单独的团体、财团、机构和独立的 DAC 已经建立，但目前还没有广泛接受的组织和职能框架。正文 我们建议 DAC，应具有促进数据共享和保护数据主体、他们的社区、数据生产者、他们的机构和科学企业的作用。我们建议，只要数据重用具有潜在的社会价值并且可预见危害的风险较低，就应由 DAC 授予数据访问权限。为促进数据共享和激励数据生产者，DAC 应鼓励符合数据生产者及其机构利益的二次使用。考虑到 DAC 的建议作用，数据访问的应用程序应该透明、简单和清晰。审查申请的方法应与所涉及的潜在风险相称。DACs 应建立在制度和法律框架内，并有明确的问责制，职权范围和成员资格。我们建议 DAC 不应模仿研究伦理委员会 (REC)，因为它们的功能和审查目标与 REC 不同。DAC 审查应遵循公共卫生伦理原则而非研究伦理原则。结论 在本文中，我们提出了一个框架，DAC 应在该框架下运作、如何组织以及如何构成它们。