A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing.

Rebekah Mcwhirter,Dianne Nicol,Don Chalmers,Jane Nielsen,Margaret Otlowski,Lisa Eckstein,Christine Critchley

doi:10.1177/1556264620920460

Abstract

Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sharing presents a significant challenge, given the diversity of practices: from defined sharing of individual patient data, to broad-scale public sharing of research data, to uploading of direct-to-consumer test data by community members. Most commentary to date has discussed these issues in broad terms, but the debate can only progress if we engage with more granularity, grounded in jurisdictional and contextual specifics. We developed an empirical approach, creating a set of prototypical scenarios that capture the diversity of current genomic data sharing practices, which allows legal and ethical analysis of key issues at a granular level. The specificity of this approach provides a strong foundation for developing useful and relevant regulatory recommendations.

Highlights

Genomic data sharing (GDS) is an increasingly expected component of genomic research and clinical practice
There is already evidence of this new wave of genomic data use translating to improved clinical care, with precision medicine offering targeted treatments tailored to individual patient’s genetic characteristics and medical history (Gagan & Van Allen, 2015; Green et al, 2011)
A culture of sharing genomic sequence data has its origins in a 1996 meeting in Bermuda, at which representatives from five major sequencing centers agreed to daily release of DNA information generated from the Human Genome Project to assemble the original human reference sequence (Cook-Deegan & McGuire, 2017)

Summary

Introduction

Genomic data sharing (GDS) is an increasingly expected component of genomic research and clinical practice. Regulatory and other governance obligations (such as privacy laws, formalized data transfer requirements, and research ethics requirements) may potentially constrain free and open GDS. These same obligations may collectively provide the assurances necessary to protect donors, encourage research and innovation, and promote ongoing public trust in GDS activities. Opportunities for widescale GDS go beyond research data to capture data generated in clinical care, with the American College of Medical Genetics Board of Directors (2017) advocating extensive sharing of both sources of genomic data to “provide the robust information necessary to improve clinical care” Opportunities for widescale GDS go beyond research data to capture data generated in clinical care, with the American College of Medical Genetics Board of Directors (2017) advocating extensive sharing of both sources of genomic data to “provide the robust information necessary to improve clinical care” (p. 721)

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Conclusion