24 September 2019
The Regulatory and Ethics Work Stream (REWS) of the Global Alliance for Genomics and Health (GA4GH) has recently undertaken a comprehensive review of its policy frameworks and guidance documents to ensure they meet the demands of the current era of genomic medicine. As part of this review, REWS has released updated versions of the GA4GH Consent Policy and the GA4GH Data Privacy and Security Policy. The team also reviewed the 2014 Framework for Responsible Sharing of Genomic and Health-Related Data and reaffirmed its suitability for the current regulatory climate.
“International regulatory developments and public engagement increasingly emphasize that responsible and respectful data sharing depends on strong privacy and security protection, and high levels of transparency with patients and participants,” said REWS Manager Adrian Thorogood, who coordinated the GA4GH policy revisions. “We decided to review GA4GH policies to strengthen these aspects and ensure the policies meet the needs of the international genomics community.”
Established in 2014 alongside the launch of GA4GH, REWS is the international thought leader on responsible and ethical genomic data sharing. To date, REWS has published four policies that build upon the foundational principles laid out in the Framework.
The revised Data Privacy and Security Policy provides guidance on protecting and promoting the security, integrity, and availability of data and services, and the privacy of individuals, families, and communities whose data are processed. The Consent Policy aims to guide international data sharing in a way that respects autonomous decision making while promoting the common good. Both policies were originally released in June 2015.
Since then, developments in data protection law and genetic privacy as well as new social challenges have arisen. These include the coming into force of the European Data Protection Regulation in May 2018—which has global implications—and the Council of Europe’s Recommendation on the protection of health-related data in March 2019.
“There is also a generally increasing need to share data collected from patients in clinical settings with researchers in many different arenas,” said Susan Wallace, who led the revision of the Consent Policy. “At the same time, healthy individuals are uploading their data to online platforms such as genealogy websites, sometimes unaware of how those data will be used. In general, we’re seeing a continued move towards giving individuals more information on and greater say in how their data are used. We wanted GA4GH policy guidance to reflect this.”
Edward Dove, a lecturer in health law and regulation at the University of Edinburgh, led the revision of the Data Privacy and Security Policy, which is intimately linked to the GA4GH Security Technology Infrastructure. “Developments in other GA4GH standards, such as the authentication and authorization infrastructure and new automated approaches for recording and tagging consent, also demanded these updates,” said Dove.
“When updating both policies, we wanted them to be in harmony with the other existing GA4GH deliverables and to remove any redundancies, inconsistencies and confusing elements based on GA4GH member feedback. The GA4GH member community was tremendous in providing helpful and insightful feedback during the rounds of policy revision,” added Dove.
All GA4GH policy work takes the unique approach of viewing data sharing as a means of activating the human right to share in the benefits of scientific advancement.
“With tens of millions of genomes expected to be sequenced within the coming decade for clinical and research purposes, the scientific community has an unprecedented opportunity to advance our global understanding of human biology and improve human health and medicine,” said Prof. Bartha Knoppers, current and founding chair of the REWS and Director of the Centre for Genomics and Policy at McGill University. “As the field develops, we in REWS are thrilled to provide guidance that will support the human right to benefit from this work.”