Access and adopt ready-to-use regulatory and ethics guidance for genomic and health-related data sharing.
The GA4GH Framework for Responsible Sharing of Genomic and Health-Related Data provides a principled and practical framework for the responsible sharing of genomic and health-related data. It contains foundational principles and core elements for responsible data sharing and is guided by human rights, including the right to benefit from the progress of science, as well as privacy, non-discrimination, and procedural fairness.
The GA4GH GDPR Forum publishes monthly “GDPR Briefs” that answer important questions about the GDPR’s impact on various aspects of international health research and genomic and health-related data sharing, and that further explore the various issues raised in the GDPR Primer.
Openness and accountability between stakeholders are needed to foster trust and collaboration. The GA4GH Accountability Policy outlines best practices for (1) monitoring and responding to non-compliance with data sharing standards and (2) transparent and accountable data sharing.
The Automatable Discovery and Access Matrix (ADA-M) provides a standardized way to unambiguously represent any and all consent and other conditions of use, making such information computer-readable and hence directly available for digital communication, searching, and automation activities.
Restrictions on data use may be necessary in order to respect the consent of research participants and patients. The GA4GH Consent Codes offer a structure for recording data use “categories” and “requirements” with a view to support maximum data use and integration.
The GA4GH Consent Tools consist of (1) a Legacy Consent and International Data Sharing, (2) Clauses for International Data Sharing, and (3) a Generic International Data Sharing Prospective Consent Form. Each requires adaptation according to local social, cultural, and legal specificities.
Sharing of genomic and health data is increasingly international, but must contend with discrepancies in the terms employed by applicable laws, ethics policies, and regulatory systems. The GA4GH Data Sharing Lexicon aims to support international data sharing by promoting common/concordant terms within the GA4GH and across jurisdictions and research contexts.
The GA4GH Ethics Review Recognition Policy aims to inspire confidence in the adequacy of an ethics review from another jurisdiction’s ethics review system on the basis of equivalent requirements and the quality of the ethics review performed as part of that system. Recognizing the diversity of legal and ethical approaches and being responsive to emerging issues, this Policy encourages the reduction of duplicative ethics reviews through recognition approaches that enable ethics committees to accept the review of another ethics committee.
The GA4GH Privacy and Security Policy aims to guide the sharing of genomic and health-related data in a way that protects and promotes the confidentiality, integrity, and availability of data and services, and the privacy of individuals, families, and communities whose data are shared.
A living inventory of international app-based human subjects research with publically available, delocalized, self-guided, internet-based, electronic informed consent processes (eConsent) with or without remote support.
The ‘Your DNA, Your Say’ project is a global online survey gathering public attitudes towards genomic data sharing using nine innovative films that explain the subject in an approachable manner. The survey is available in numerous languages, with more translations to come. English language results will be available in 2018. The findings from the survey will help to ensure GA4GH policies and tools are informed by the people they are ultimately designed to serve.