The HRA welcomes new government guidance on safeguarding UK human genomic data, setting out expectations for how major holders of human genomic data can enable research while maintaining appropriate security safeguards through Secure Data Environments, controls on international access to genomic data and protective security measures based on the Five Safes approach.
The publication is timely following recent concerns relating to UK Biobank data. Public trust depends on strong governance, proportionate safeguards and swift action when things go wrong. The guidance strengthens expectations around data security and access, while recognising the important role of existing governance arrangements, including the HRA's UK Policy Framework for Health and Social Care Research, in supporting trustworthy research.
As the organisation responsible for co-ordinating and standardising health and social care research governance, the HRA has an important role in helping ensure that emerging data access arrangements support research that is secure, proportionate and trusted.
Dr Matt Westmore, Chief Executive, Health Research Authority"The UK has some of the world's most important health and genomic research resources that could lead to major advancements in how we understand, diagnose or treat disease. Protecting data and maintaining the trust that participants place in its appropriate use, is essential.
“This new guidance is an important step in strengthening confidence in how human genomic data is accessed, safeguarded and used for research and innovation."
Dr Jonathan Fennelly-Barnwell, Interim Director of Approvals, Health Research Authority“Technical safeguards, Secure Data Environments and output controls are important as part of the wider research governance framework that ensures people can be confident in research.
“The HRA's role is to help make expectations clear, consistent and proportionate for all health and social care research, including research that only involves accessing data. That means clear sponsorship, transparency, public involvement and appropriate confidentiality safeguards, with sponsors retaining oversight of how data access fits with the research as a whole.”
We look forward to working with partners across the research system to implement this guidance and continue to support a clear, consistent and proportionate approach to research governance that people can trust.