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. 2019 Mar 28;20(1):21.
doi: 10.1186/s12910-019-0359-9.

Responsible data sharing in international health research: a systematic review of principles and norms

Shona Kalkman  1 , Menno Mostert  2 , Christoph Gerlinger  3   4 , Johannes J M van Delden  2 , Ghislaine J M W van Thiel  2
Affiliations

Responsible data sharing in international health research: a systematic review of principles and norms

Shona Kalkman et al. BMC Med Ethics. .

Abstract

Background: Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation (GDPR), the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, we set out to explore relevant ethical principles and norms.

Methods: We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research.

Results: We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used.

Conclusions: While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust.

Keywords: Big data; Data sharing; Ethical governance; Research ethics; Secondary use.

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The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Flow diagram of the selection and inclusion of publications
See this image and copyright information in PMC

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