Yesterday the government announced that data from UK Biobank had been advertised for sale online.
The UK Biobank is the world’s most comprehensive biomedical dataset, holding the records of more than half a million volunteers.
It is a unique, and enormously important national research resource, that has been built on the generosity and trust of participants who have willingly shared their personal data.
That trust depends on strong governance, proportionate safeguards and swift action when things go wrong.
The Health Research Authority, through Research Ethics Committees (REC) and the Confidentiality Advisory Group (CAG), plays a key role in scrutinising how biobanks are designed, approved for use and operated.
Biobanks can contain large datasets which researchers can apply for approval to access. Researchers apply directly to the biobank for access to data or tissue for studies. The information contained within UK Biobank was de-personalised and did not contain identifiable information.
Access to UK Biobank for researchers is granted by the biobank, based on the wider REC or CAG approval the biobank had already received, and subject to a rigorous vetting process. Following this process is a condition of REC approval.
The UK Biobank was given approval in April 2021 following a review by the North West - Haydock REC. The approval was due to be reviewed in April 2026, but a 6 month extension was granted following a request from UK Biobank.
The review and approval process carried out by REC and CAG is led by volunteers who either have expertise in research or are members of the public. They consider the potential benefits of allowing access to this data, whilst ensuring there are robust protections in place for participants and their data.
UK Biobank participants can take assurance from these reviews which are carried out by volunteers whose role is to protect their interests. It is just one part of a wider set of assurances provided by organisations, including the Information Commissioner's Office, so that people can be confident to choose to take part in research.
There will always be a balance to strike between enabling world-leading research that can lead to new treatments, and maintaining the highest possible standards of data security. The REC consider that balance on behalf of the public and will expect transparency and clear information to be provided to people who allow their data to be included.
We welcome the swift action taken by the UK Biobank team to suspend access to the dataset following the news that it had been made available online.
It mitigates what we understand to be the actions of those who have accessed the data but have operated outside of the agreed rules for use.
The actions of these people undermine public trust in research, but do not reflect the behaviour of the overwhelming majority of researchers in the UK who proudly carry out their vital work to some of the highest standards in the world.
We are currently investigating whether a serious breach has occurred based on the REC approval previously provided for use of UK Biobank data.
This investigation will follow our established procedures, and we will follow the standard procedures to deal with the outcome of the investigation as soon as possible.
Chief ExecutiveMatt Westmore