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.
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Work with like-minded groups committed to better data use in areas like rare disease, cancer, and infectious disease.
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4 Mar 2019
Informed consent is a powerful ethico-legal requirement in most interventional biomedical research involving human participants. But consent to participate in research is a distinct notion from consent pursuant to the GDPR.
Informed consent is a powerful ethico-legal requirement in most interventional biomedical research involving human participants. But consent to participate in research is a distinct notion from consent pursuant to the GDPR. While consent is the primary basis for interventional research for ethical and medico-legal reasons, data protection law provides more flexibility. Under the GDPR, processing of personal data is lawful only if one has a legitimate basis. The six acceptable lawful bases are stipulated in Article 6, of which consent is but one (Article 6(1)(a)). Article 6 should be read in light of Recital 50, which states that further processing for scientific research purposes should be considered to be a compatible processing operation that requires no further or separate lawful basis. So, while consent is one ground for processing, there are also other justifications. And, indeed, where scientific research is carried out as a secondary purpose, then no further lawful basis is needed.
Researchers should consider relying on a lawful basis other than consent for processing personal data for scientific research for at least two reasons. First, the interpretation of consent and what forms a valid consent and how it is to be recorded differs not only between the fields of data protection and research ethics, but also across countries (e.g. what is “informed”, how “broad” can a broad consent be), potentially disrupting international research collaboration. There would also be a need to include the identity of all parties relying on the consent. Second, the possibility of a withdrawal of consent will complicate the situation where data must be removed from a repository. If consent is used as the lawful basis for processing data and a research participant withdraws consent, the controller will no longer have a lawful basis to process personal data about them, unless the data are also processed for another purpose which justifies retention without consent.
Other, potentially more useful, lawful bases under Article 6 include legitimate interests and tasks carried out in the public interest. A crucial consideration when processing “special categories” of personal data such as genetic data and data concerning health is the condition under Article 9(2)(j) that allows these data to be processed on the grounds of scientific research purposes, based on EU or Member State law. Processing these data on the grounds of scientific research purposes can enable organizations to work around the obligation to secure data subjects’ consent for processing.
Edward S. Dove, “The EU General Data Protection Regulation: Implications for International Scientific Research in the Digital Era” (2018) 46 Journal of Law, Medicine & Ethics 1013-1030. Available here.
European Data Protection Board (EDPB), Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)). Available here.
Information Governance Alliance, The General Data Protection Regulation: What’s New (2018). Available here.
Relevant GDPR Provisions
Edward Dove is a Lecturer in Law at the University of Edinburgh. His primary research interests are in the areas of health research regulation, research ethics oversight, health-related data access and sharing, and governance of international research collaboration.
For a list of previous briefs, please consult here.
Please note that GDPR Briefs neither constitute nor should be relied upon as legal advice. Briefs represent a consensus position among Forum Members regarding the current understanding of the GDPR and its implications for genomic and health-related research. As such, they are no substitute for legal advice from a licensed practitioner in your jurisdiction.