New GDPR transparency wording for all sponsors

Darperir y cynnwys hwn yn allanol ac yn Saesneg yn unig.

To help ensure research participants have all the information they need to make an informed decision about the use of their data, the Health Research Authority (HRA) have developed a new GDPR template that they expect sponsors to use.

When you should use this GDPR wording

From 1 April 2025, for any new research applications submitted via IRAS you will be expected to either:

• use the new GDPR transparency wording template for all sponsors, or
• demonstrate how your own bespoke wording meets the four principles for meaningful involvement of patients and the public in health and social care research.

This template is designed to help you in your communications to research participants.

Should you update the GDPR wording in your open studies?

There is no need to update the GDPR wording in your open studies. If you choose to do this, you can update it to the HRA’s transparency wording as a non-substantial, non-notifiable amendment. This means that you do not need to notify the REC, national coordinating functions or research management functions of participating NHS and HSC organisations. You should work with your research delivery teams to enable this to be provided to participants as appropriate.

If you have bespoke GDPR transparency wording which was approved for submissions before 1 April 2025 and you want to update it, you should do one of the following:

• use the HRA’s new GDPR transparency wording. You can do this as a non-substantial, non-notifiable amendment
• update your own bespoke wording. If you choose this option, we expect you to justify why you cannot use the HRA’s GDPR transparency wording and demonstrate how your own wording meets the principles of meaningful involvement. You can update your wording when you submit your next full application.

More information on this policy can be found on the HRA website.