BackgroundSharing 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 textWe 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.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

Contemporary healthcare practice has been progressively more regulated to increase efficiency, service user safety and practice quality. However, ethical issues in clinical practice that have not been implemented into regulations are undervalued by policymakers and healthcare institutions Considering the issues found by other authors, the use of a simple tool for policymakers to consider recurrent ethical issues could reduce those issues in a policy-driven clinical practice. The lack of tools to support structured ethical assessment of clinical policies was the main (...) reason to create the Clinical Policy Ethics Assessment Tool, but we realised of its possible advantages: limiting ethical dilemmas posed by policies, ensuring ethical practice by the use of policies and developing a consistent process for policymakers, institutions and healthcare professionals. Nonetheless, even if a tool can be implemented and it supports the creation of policies that reduce ethical issues, if the healthcare professionals are not aware of them they will not be implemented and the issues will continue. (shrink)