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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Policy on Clinically Actionable Genomic Research Results

The GA4GH Policy on Clinically Actionable Genomic Research Results aims to provide a reference point for managing the return of such results that recognizes the importance of the accountability and transparency of genomic researchers towards participants. It also acknowledges the differing levels of evidence behind the clinical utility of such information, and the complexities involved in returning it to individuals in an ethically and legally appropriate manner. The Policy aims to identify common ground while also allowing for appropriate customization by locale and by research project.

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Familial Consent Clauses

Familial Consent Clauses provides researchers with a typology of clauses describing familial consent clauses from studies around the world. Each sample clause can be adapted to fit different research and legal contexts, making this guidance useful to genetics and precision medicine studies around the globe.

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Copyright Policy

The GA4GH Copyright policy ensures that the GA4GH has clear rights under copyright law to adapt and utilize individual and institutional contributions, incorporate them into GA4GH standards, and to distribute those standards widely. The policy encourages open and collaborative participation of institutions and individuals in standards development, and aims to recognize those who contribute.

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Consent Clauses for Genomic Research

The GA4GH Consent Clauses for Genomic Research provides researchers with sample phrases addressing various consent elements. Each sample clause can be adapted to fit different research and legal contexts, making this guidance useful to genetics and precision medicine studies around the globe.

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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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Data Privacy and Security Policy

The GA4GH Data 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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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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Machine Readable Consent Guidance

The GA4GH Machine Readable Consent Guidance provides instructions for researchers integrate standard data sharing language into consent forms in a way that is able to be translated to a computable language. Machine readable consent language is able to be attached to datasets and stored in their descriptive data using DUO terms. Researchers can then search for datasets that have been consented to for their research purposes.

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Model consent clauses for rare disease research

Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, GA4GH and IRDiRC have developed model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection.

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ONGOING REWS PROJECTS

The following are ongoing projects developed by the Regulatory and Ethics Work Stream.

 

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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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. Please see the Your DNA Your Say website for the latest outcomes from the project; the first publication on the between-country analysis of attitudes towards genomic data sharing is published in the American Journal of Human Genetics.

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ARCHIVED REWS POLICIES

The following tools were developed prior to the establishment of the GA4GH Policy Approval Process or have been archived. These policy frameworks and tools are no longer actively maintained by GA4GH. They may be updated and approved in the future.

 

Accountability Policy

 

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Automatable Discovery and Access Matrix

Replaced by the Data Use Ontology, maintained by the GA4GH DURI Work Stream.

 

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Consent Codes

Replaced by the Data Use Ontology, maintained by the GA4GH DURI Work Stream.

 

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Available resources

Consent Tools

 

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Data Sharing Lexicon

 

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Privacy-Preserving Record Linkage

 

Mobile Health Consent Inventory

 

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Available resources