Data Access Committees

Phaik Yeong Cheah,Jan Piasecki

doi:10.1186/s12910-020-0453-z

Abstract

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.

Highlights

We propose that Data Access Committee (DAC), 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
The landscape of research ethics is evolving and after the eras of researcher and regulatory paternalism [11], a new paradigm shift is being discussed: an ethical framework for learning healthcare systems [12]. This paradigm brings a few new ideas. It puts into question the difference between research and routine clinical practice: new information technologies alter the nature of medical practice, which has recently become a learning activity where its goals are not limited to benefiting an individual patient, and embraces the generation of knowledge
We suggest that DACs should not be modelled after research ethics committees (RECs) and give reasons why

Summary

Introduction

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. Unlike primary research, data access should be granted as long as the data reuse fulfils the criterion of having even a minimal social value [7], and minimal risk to data subjects and their communities (we discuss risks to primary researchers and their institutions later in the paper). Sharing de-identified individual-level health research data is widely promoted and has many potential benefits.

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Conclusion