This is the repository for the GA4GH Regulatory and Ethics Work Stream (REWS) Consent Policy. Here you can find our Consent Policy documents, as well as related community-led discussions around consent.
This policy provides guidelines for the international sharing of genomic and related health data. Informed consent is a bedrock principle underlying the ethical conduct of research and clinical practice. The Consent Policy aims to guide the sharing of genomic and related health data in a way that respects autonomous decision-making while promoting the common good of international data sharing. Developed by the GA4GH Regulatory & Ethics Work Stream (REWS), the Consent Policy aims to maximise responsible and respectful global data sharing through the design of consent forms for data collection.
The Consent Policy encompasses data that have been consented to by data donors or their legal representatives, or approved for use by competent authorities in compliance with national and international laws, general ethical principles, and best practices that respect restrictions on downstream uses. This includes recognition that the consent process is situated within and overseen by appropriate governance mechanisms.
This policy is founded on the following basic principles:
- consent is an open, communicative and, ideally, continuing relationship;
- there is an intention to share data across clinical or research groups, or jurisdictions and national borders, with appropriate approvals in place;
- plans for data sharing should be transparent, understandable, and accessible;
- data donors have a right to not participate in international data sharing or, if participating, are able to withdraw, with the understanding that it may not be possible to retrieve or destroy data once shared;
- data users and data producers will abide by applicable regulations and ethical norms when seeking and conducting international data sharing.
- Provides translatable best practices to implement informed consent
- Promotes lawful and ethical data sharing consistent with a data subject’s consent, authorisation by competent authorities, and applicable laws
Ethics review committees, and data protection authorities
The associated publication can be found here from (Siu et al. 2016, Nature Medicine): [https://doi.org/10.1038/nm.4089].