Learn how GA4GH helps expand responsible genomic data use to benefit human health.
Learn how GA4GH helps expand responsible genomic data use to benefit human health.
Our Strategic Road Map defines strategies, standards, and policy frameworks to support responsible global use of genomic and related health data.
Discover how a meeting of 50 leaders in genomics and medicine led to an alliance uniting more than 5,000 individuals and organisations to benefit human health.
GA4GH Inc. is a not-for-profit organisation that supports the global GA4GH community.
To guide our collaborative, globe-spanning alliance, GA4GH relies on a Standards Steering Committee and an Executive Committee.
The Funders Forum brings together organisations that offer both financial support and strategic guidance.
The EDI Advisory Group responds to issues raised in the GA4GH community, finding equitable, inclusive ways to build products that benefit diverse groups.
Distributed across four Host Institutions, our staff team supports the mission and operations of GA4GH.
Curious who we are? Meet the people and organisations across six continents who make up GA4GH.
More than 500 organisations connected to genomics — in healthcare, research, patient advocacy, industry, and beyond — have signed onto the mission and vision of GA4GH as Organisational Members.
These core Organisational Members are genomic data initiatives that have committed resources to guide GA4GH work and pilot our products.
This subset of Organisational Members whose networks or infrastructure align with GA4GH priorities has made a long-term commitment to engaging with our community.
Local and national organisations assign experts to spend at least 30% of their time building GA4GH products.
Anyone working in genomics and related fields is invited to participate in our inclusive community by creating and using new products.
Wondering what GA4GH does? Learn how we find and overcome challenges to expanding responsible genomic data use for the benefit of human health.
Study Groups define needs. Participants survey the landscape of the genomics and health community and determine whether GA4GH can help.
Work Streams create products. Community members join together to develop technical standards, policy frameworks, and policy tools that overcome hurdles to international genomic data use.
GIF solves problems. Organisations in the forum pilot GA4GH products in real-world situations. Along the way, they troubleshoot products, suggest updates, and flag additional needs.
NIF finds challenges and opportunities in genomics at a global scale. National programmes meet to share best practices, avoid incompatabilities, and help translate genomics into benefits for human health.
Communities of Interest find challenges and opportunities in areas such as rare disease, cancer, and infectious disease. Participants pinpoint real-world problems that would benefit from broad data use.
See all our products — always free and open-source. Do you work on cloud genomics, data discovery, user access, data security or regulatory policy and ethics? Need to represent genomic, phenotypic, or clinical data? We’ve got a solution for you.
All GA4GH standards, frameworks, and tools follow the Product Development and Approval Process before being officially adopted.
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Help create new global standards and frameworks for responsible genomic data use.
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The Framework sets forth a harmonized and human rights approach to responsible data sharing in accordance with Foundational Principles and Core Elements.
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The sharing of genomic and health-related data for biomedical research is of key importance in ensuring continued progress in our understanding of human health and wellbeing. The challenges raised by international, collaborative research require a principled but nevertheless practical Framework that brings together regulators, funders, patient groups, information technologists, industry, publishers, and research consortia to share principles about data exchange. Such a Framework will facilitate responsible research conduct.
This Framework is developed under the auspices of the Global Alliance for Genomics and Health. Its mission is to accelerate progress in human health by helping to establish a common Framework of harmonized approaches to enable effective and responsible sharing of genomic and clinical data and to catalyze data sharing projects that drive and demonstrate the value of data sharing.
This Framework provides guidance for the responsible sharing of human genomic and health-related data, including personal health data and other types of data that may have predictive power in relation to health. In particular, it highlights, and is guided by, Article 27 of the 1948 Universal Declaration of Human Rights. Article 27 guarantees the rights of every individual in the world “to share in scientific advancement and its benefits” (including to freely engage in responsible scientific inquiry), and at the same time “to the protection of the moral and material interests resulting from any scientific…production of which [a person] is the author.” (As set out in Appendix 1, many other international conventions and national laws, regulations, codes and policies also guide responsible data
This Framework is guided by the human rights of privacy, non-discrimination and procedural fairness. At the same time, it considers all human rights principles relevant, complementary and interrelated, founded as they are on respect for human dignity. Since science proceeds only with the broad support of society, respect for all persons is a primary driver underlying all other derived principles. In
particular, this Framework establishes a set of foundational principles for responsible research conduct and oversight of research data systems in the realm of genomic and health-related data sharing. It interprets the right of all people to share in the benefits of scientific progress and its applications as being the duty of data producers and users to engage in responsible scientific inquiry and to access and share genomic and health-related data across the translation continuum, from basic research through practical applications. It recognizes the rights of data producers and users to be recognized for their contributions to research, balanced by the rights of those who donate their data. In addition to being founded on the right of all citizens in all countries to the benefits of the advancements of science, and on the right of attribution of scientists, it also reinforces the right of scientific freedom.
The value of this Framework is that it: offers political and legal dimensions that reach beyond the moral appeals of bioethics and provides a more robust governance framework for genomic and health-related data sharing; speaks to groups and institutions, not just individuals; stresses the progressive realization of duties; and urges action by governments, industry, funders, publishers, and researchers to create an international environment for responsibly sharing data.
This Framework will be elaborated by subsequent Policies (Appendix 2) on particular issues such as ethical governance, consent, privacy and security. The Framework and its subsequent Policies should be used in projects around the world (whether Global Alliance “inspired” or not) such that they become the tools that approval entities, recognized by different jurisdictions, will turn or refer to for guidance. Recognizing diversity of legal and ethical approaches and being responsive to emerging issues, both this Framework and its Policies are intended to provide leadership in this domain for wider discussion.
The purpose of this Framework is to provide a principled and practical framework for the responsible sharing of genomic and health related data. Its primary goals are to:
Without ascribing legal meaning, this Framework should be interpreted in good faith and is to be understood as a whole. The Foundational Principles and Core Elements are to be understood as complementary and interrelated, as appropriate and relevant in different contexts, countries and cultures. This Framework will be supported by Policies for guidance in particular issues such as, but not limited to, ethical governance, privacy and security, and consent. For the purposes of this Framework, “data sharing” includes data transfer or data exchange between data users, or where data are made available to secondary researchers, either openly or under specified access conditions.
This Framework is intended for all entities or individuals providing, storing, accessing, managing or otherwise using genomic and health-related data, including data donors, users, and producers. This includes, but is not limited to, researchers, research participants and patient communities, publishers, research funding agencies, data protection authorities, hospitals, research ethics committees, industry, ministries of health, and public health organizations.
The Foundational Principles of this Framework guide the responsible sharing of genomic and healthrelated data. They also facilitate compliance with the obligations and norms set by international and
national law and policies.
It is good practice for those involved in genomic and health-related data sharing to have core elements of responsible data sharing in place. The following Core Elements of the Framework aid in the interpretation of the Foundational Principles to individuals and organizations involved in the sharing of genomic and health-related data. The Core Elements should be interpreted in a proportionate manner that acknowledges different levels of risk and community cultural practices. This Framework applies to use of data that have been consented to by donors (or their legal representatives) and/or approved for use by competent bodies or institutions in compliance with national and international laws, general ethical principles, and best practice standards that respect restrictions on downstream uses. Endorsement of the Framework does not preclude the development of particular guidance via Policies for specific populations (e.g. children) or issues (e.g. ethical governance, privacy and security, and consent).
This Framework for Responsible Sharing of Genomic and Health-Related Data is the result of the work of many people and committees. Developed under the auspices of the Global Alliance for Genomics and Health, the Framework was initially formulated by an international committee (Regulatory and Ethics Working Group) representing a wide spectrum of the bioethics, genomics, and clinical communities. Collaborative input was provided from individuals as well as biomedical, patient advocacy, and ethical, policy and legal organizations, committees, and projects from all regions of the world. These include, but are not limited to:
* Universal Declaration of Human Rights (UN 1948) (Article 27)
* International Covenant on Economic, Social and Cultural Rights (UN 1966) (Article 15)