Clinical research studies within the NHS in England and Wales require Health Research Authority (HRA) approval, which brings together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). The HRA has recently changed the requirements for the UK GDPR transparency wording in new health and social care research applications submitted via the Integrated Research Application System (IRAS). The HRA service had previously provided a review service for sponsors’ GDPR transparency statements. In October last year, the HRA communicated its new updated GDPR template to all sponsors. The new HRA template was developed to ensure that research participants have all the information that they need to make an informed decision about the ways in which their personal data can be used during a clinical trial.

Following the introduction of the new HRA template, a transition period allowed sponsors to use previous wording or their own bespoke wording (provided it had been approved by the HRA) instead of the new template. However, the transition period will expire on 31st March, after which sponsors may only use the new HRA template.

Sponsors may also use their own bespoke UK GDPR wording, which must meet the four principles, which are as follows:

  • Principle 1: Involve the right people. The HRA expects sponsors to take into account the differing views of a broad range of affected stakeholders;
  • Principle 2: Involve enough people: The HRA expects sponsors to involve enough people to ensure that they have captured a sufficient diversity of experience and perspectives;
  • Principle 3: Involve those people enough: Sponsors should ideally have two rounds of involvement; the first to receive people’s feedback on the initial draft, and the second to receive feedback on any amendments to ensure these secondary changes have achieved the desired effect;
  • Principle 4: Describe how it helped: The HRA expects sponsors to be able to explain what feedback was received, and the changes made to their UK GDPR transparency document to address that feedback.

The HRA says that new bespoke UK GDPR transparency wording submissions made during the transitional period will be evaluated on a case-by-case basis, but that the sponsor will be expected to explain why they could not immediately use the HRA UK GDPR transparency template wording. Sponsors in the process of making any new research application should be aware of the change, and from 1st April 2025 will need to utilise the new HRA template.