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

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

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

Rebekah McWhirter 1, Lisa Eckstein 1, Don Chalmers 1, Christine Critchley 1 2, Jane Nielsen 1, Margaret Otlowski 1, Dianne Nicol 1

Affiliations 

• PMID: 32425102
 
• 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.

Keywords: ELSI; data sharing; ethics; genomics; law.

Similar articles

• Genomics and High-Consequence Infectious Diseases: A Scoping Review of Emerging Science and Potential Ethical Issues.

  Boyce AM, Garibaldi BT.Health Secur. 2019 Jan/Feb;17(1):62-68. doi: 10.1089/hs.2018.0108. Epub 2019 Feb 6.PMID: 30724614 Free PMC article. Review.
• Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?

  Shabani M, Dove ES, Murtagh M, Knoppers BM, Borry P.Biopreserv Biobank. 2017 Oct;15(5):469-474. doi: 10.1089/bio.2017.0045. Epub 2017 Aug 24.PMID: 28836815 Review.
• Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative.

  Matimba A, Chimatira A, Kuguyo O, January J, Mupambireyi Z, Marimbe-Dube B, Chikwasha V, Nyati-Jokomo Z, Muteti S, Mangezvo P, Kangwende A, Chingono A, Chidzonga M, Gandari J, Hakim J, Nathoo K, Samkange C, Mangezi W, Lee S, Gwanzura L, Cho M, Ndebele P.Version 2. AAS Open Res. 2019 Jun 12;2:1. doi: 10.12688/aasopenres.12917.2. eCollection 2019.PMID: 32382699 Free PMC article.
• Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study.

  Manion FJ, Robbins RJ, Weems WA, Crowley RS.BMC Med Inform Decis Mak. 2009 Jun 15;9:31. doi: 10.1186/1472-6947-9-31.PMID: 19527521 Free PMC article. Clinical Trial.
• Clinical genetic research 3: Genetics ELSI (Ethical, Legal, and Social Issues) research.

  Pullman D, Etchegary H.Methods Mol Biol. 2015;1281:369-82. doi: 10.1007/978-1-4939-2428-8_22.PMID: 25694322