Regulatory and Ethics Work Stream Lead: Professor Bartha Maria - - PowerPoint PPT Presentation

genomicsandhealth.org

Regulatory and Ethics Work Stream

Lead: Professor Bartha Maria Knoppers Lead: Professor Madeleine Murtagh Manager: Adrian Thorogood

16 October 2017 WS Presentations

genomicsandhealth.org

Regulatory and Ethics Work Stream (Overview)

Roles:

• Ac>vate the human right of everyone to

benefit from the progress of science

• Promote forward-looking governance
• Harmonize governance across countries,

sectors, insAtuAons, and projects.

genomicsandhealth.org

REWS Toolkit

3

• Consent Policy
• Consent Clauses

and Template for InternaAonal Data Sharing

• Consent Codes
• Privacy &

Security

• Lexicon
• Accountability
• Ethics Review

Equivalency Framework for Responsible Sharing of Genomic and Health-Related Data

genomicsandhealth.org

Regulatory and Ethics Work Stream (Plans)

• 1. Ensure Data sharing serves and is informed by

paAents/parAcipants à YourDNAYourSay.org

• 2. Harmonize processes for handling individual

genomic findings of clinical relevance à Return of Results Task Team

• 3. Clarify Data ProtecAon Rules à Interna>onal data

sharing Code of Conduct

genomicsandhealth.org

Regulatory and Ethics Work Stream (Plans)

• Review Work Stream Products
• Engage with Driver Projects to idenAfy common and

emerging issues and to harmonize real-world governance:

ClinGen Erin Riggs/Danielle AzzariA MME BRCA Challenge VICC ICGCmed ARGO Howard Simkevitz/Emily Kirby NIH & NCI Commons/GDC ELIXIR Beacon Stephanie Dyke ENA/EVA/EGA Giselle Kerry Monarch Ini>a>ve Melissa Haendel PMI / All of Us Meg Doerr/Kate Blizinsky CanDIG Genomics England Laura Riley/Augusto Rendon Australian Genomics Clara Gaff Human Cell Atlas

genomicsandhealth.org

Work Stream Name

Q&A