Views of Ethical Best Practices in Sharing Individual-Level Data From Medical and Public Health Research: A Systematic Scoping Review.

Susan Bull,Michael Parker,Nia Roberts

doi:10.1177/1556264615594767

Susan Bull, Michael Parker + Show 1 more

Open Access

https://doi.org/10.1177/1556264615594767

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Abstract

There is increasing support for sharing individual-level data generated by medical and public health research. This scoping review of empirical research and conceptual literature examined stakeholders’ perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings. Sixty-nine empirical and conceptual articles were reviewed, of which, only five were empirical studies and eight were conceptual articles focusing on low- and middle-income settings. We conclude that support for sharing individual-level data is contingent on the development and implementation of international and local policies and processes to support ethical best practices. Further conceptual and empirical research is needed to ensure data sharing policies and processes in low- and middle-income settings are appropriately informed by stakeholders’ perspectives.

Highlights

Policies mandating the sharing of individual-level data from biomedical and public health research are becoming widespread and commanding increasing support from large funding bodies, regulatory agencies, and the pharmaceutical industry (Medical Research Council, 2011; National Institutes of Health, 2003; Nisen & Rockhold, 2013; Research Information Network, 2008; Toronto International Data Release Workshop Authors 2009; UK Data Archive, 2011; Walport & Brest, 2011; Wellcome Trust, 2009)
Experiences of data release for genomic research suggest that challenges raised by individual-level data sharing in low- and middle-income settings will be different in important and morally significant ways from those arising in high-income settings (Parker et al, 2009)
Significant consensus about some aspects of best practice is evident, such as the need to protect the privacy of research participants, there are differences of opinion about practical achievement of these, such as the measures needed to protect privacy and the extent to which privacy can be assured (Gotzsche, 2011b; Mello et al, 2013; Nisen & Rockhold, 2013)

Summary

Introduction

Policies mandating the sharing of individual-level data from biomedical and public health research are becoming widespread and commanding increasing support from large funding bodies, regulatory agencies, and the pharmaceutical industry (Medical Research Council, 2011; National Institutes of Health, 2003; Nisen & Rockhold, 2013; Research Information Network, 2008; Toronto International Data Release Workshop Authors 2009; UK Data Archive, 2011; Walport & Brest, 2011; Wellcome Trust, 2009). The increasing amount of clinical and public health research being conducted in low- and middle-income settings has the potential to generate datasets of significant value to researchers seeking to address disease burdens in such settings (Manju & Buckley, 2012). Experiences of data release for genomic research suggest that challenges raised by individual-level data sharing in low- and middle-income settings will be different in important and morally significant ways from those arising in high-income settings (Parker et al, 2009). Timely data sharing may be important in low- and middle-income settings to inform effective and urgently needed public health interventions, it is important that data sharing is conducted in a way that does not disadvantage or harm researchers, research institutions, communities, and participants in such settings.

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