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.
Learn how other organisations have implemented GA4GH products to solve real-world problems.
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Help create new global standards and frameworks for responsible genomic data use.
Align your organisation with the GA4GH mission and vision.
Solve your real-world data problems with support from this valuable network of global institutions.
Work with like-minded groups committed to better data use in areas like rare disease, cancer, and infectious disease.
Share your thoughts on all GA4GH products currently open for public comment.
Solve real problems by aligning your organisation with the world’s genomics standards. We offer software dvelopers both customisable and out-of-the-box solutions to help you get started.
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See new projects, updates, and calls for support from the Work Streams.
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24 Mar 2016
Genomic research holds great potential to advance human health and medicine. However, for the millions of data points now being collected through large-scale sequencing efforts to be truly valuable, they must be analyzed in aggregate and shared across institutions and jurisdictions.
MONTREAL, CANADA — Genomic research holds great potential to advance human health and medicine. However, for the millions of data points now being collected through large-scale sequencing efforts to be truly valuable, they must be analyzed in aggregate and shared across institutions and jurisdictions. But aggregating and sharing data brings many challenges, including the navigation of complex ethics approval processes at multiple sites and in multiple jurisdictions. To do this, researchers must often obtain ethics approval from research ethics committees (RECs) relating to the sites, who are responsible for protecting human research subjects from harm and ensuring their interests and welfare.
In a Policy Forum article published this week in the journal Science, members of the Ethics Review Equivalency (ERE) Task Team of the Global Alliance for Genomics and Health (GA4GH) Regulatory and Ethics Working Group (REWG) discuss this challenge and ways to address it, particularly through ad hoc models for achieving ethics review “mutual recognition” around the globe.
“As more data are shared and research becomes increasingly networked and collaborative, national research governance structures are beginning to address the need for harmonization of procedures and standards between RECs. For instance, only one REC is needed to approve a domestic multi-site genomic research project in the UK,” said Edward Dove, a doctoral candidate at the University of Edinburgh School of Law in the UK, ERE Task Team Coordinator, and lead author. “But these governance or regulatory reforms don’t apply when data are shared internationally. Internationally, the challenges are myriad and remain unresolved. Multiple, and often duplicative, ethics approvals are needed, without any evidence that these benefit participants, science, or society. Unless a process for harmonizing such reviews can be identified, data-intensive international research will remain inefficient and underperforming due to redundancy in the system.”
As a first step toward achieving mutual recognition among ethics committees, the ERE Task Team met in Hermance, Switzerland in June 2015 to identify and develop models of ethics review used around the globe, as well as ethics review methods that will enable more efficient sharing of genomic and clinical data for research. Funded by the Public Population Project in Genomics and Society (P3G), the Wellcome Trust, and the Brocher Foundation, the meeting’s attendees included ethics experts from Australia, Belgium, Canada, the Netherlands, the UK, the USA, and South Africa. Through discussions grounded both in theory and practical experience, participants identified three models of mutual recognition: reciprocity, delegation, and federation. In many cases, some combination of all three takes place, leading to an ad hoc, mix-and-match approach.
Current models for reform have multiple variations and come with advantages and disadvantages, which are outlined in the article. For instance, reciprocity allows for flexible review standards, but can be time consuming at the initial implementation stage. Federation, while reducing costs and duplication efforts of multiple RECs, is difficult to implement because of challenges in getting several jurisdictions to agree on policy and standards.
“Ultimately, what we need is an international organization that has the authority and multi-stakeholder support to enable an ethics review mutual recognition system for data-intensive international research,” said Bartha Knoppers, Director of the Centre of Genomics and Policy at McGill University, Chair of P3G, and Chair of the GA4GH REWG. In the meantime, however, the ad hoc models outlined in the paper provide a framework to guide current international data-sharing initiatives.
Knoppers added that “the GA4GH has a key role to play by working with regulatory authorities on regional, national, and international levels.” To that end, the ERE Task Team will hold a second symposium to take place in Montreal in May 2016 that will convene researchers, industry members, ethics experts, policymakers, and regulators from around the globe to extend the work that began at the Brocher Foundation in 2015.
“In 2014, the ERE Task Team began an in-depth discussion on the emerging issue of data-intensive international research and sought to rethink a system that has been in place for more than fifty years and hasn’t kept pace with developments in science,” said David Townend, Professor of Law and Legal Philosophy in Health, Medicine, and Life Sciences at Maastricht University in the Netherlands and Chair of the ERE Task Team. “We are beginning to develop practical solutions for this incredibly complex and valuable issue, which is clearly at the forefront of researchers minds and is of international concern. It is an exciting time.”
The Global Alliance for Genomics and Health is an international, non-profit alliance formed to accelerate the potential of genomic medicine to advance human health. Bringing together over 350 leading organizations working in healthcare, research, disease and patient advocacy, life science, and information technology, GA4GH Members are working together to create a common framework of tools, methods, and harmonized approaches and supporting demonstration projects to enable the responsible, voluntary, and secure sharing of genomic and clinical data. Learn more at: http://genomicsandhealth.org.