Regulatory & Ethics Toolkit


Access and adopt ready-to-use regulatory and ethics guidance for genomic and health-related data sharing.

Framework for Responsible Sharing of Genomic and Health-Related Data

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.

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GDPR & International Health Data Sharing Forum

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.

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Accountability Policy

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.

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Automatable Discovery and Access Matrix

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.

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Consent Codes

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.

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Consent Policy

The GA4GH Consent Policy aims to guide the sharing of genomic and health-related data in a way that respects autonomous decision-making while promoting the common good of international data sharing.

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Consent Tools

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.

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Data Sharing Lexicon

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.

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Ethics Review Recognition Policy

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.

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Privacy-Preserving Record Linkage

Health data research, especially in the case of rare disease patients, can strongly benefit from reliable linkage of patients’ datasets obtained from independent research projects. The Privacy-Preserving Record Linkage (PPRL) Task Force, a collaboration between GA4GH and the International Rare Disease Research Consortium (IRDiRC), was established to address ethico-legal and technical challenges to connecting datasets produced by different organizations and/or investigators. The Task Force recommends the European patient-identity management solution (EUPID), which was developed by the European Network for Cancer Research in Children and Adolescents (ENCCA) and uses algorithms to generate a context-specific pseudonym for each individual, as the technological approach most aligned with IRDIRC and GA4GH’s global research environment. The Task Force also recommends several ELSI features for institutions to incorporate during the design of a PPRL system such as the use of a trusted cryptographic hashing method to enable linkage or the separation among trusted entities of the linkage and re-identification duties (See “Ethico-Legal Considerations” for more details).

Privacy and Security Policy

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.

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Mobile Health Consent Inventory

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.

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Your DNA, Your Say (Participant Values Survey)

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.

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