 What: we have published a new GDPR transparency statement for use in participant information sheets, and have made changes to the submission and approval process for bespoke sponsor GDPR language
Who: all sponsors carrying out health and social care research in England, Wales, Scotland and Northern Ireland
When: from Tuesday 1 April 2025
From today, 1 April, the way you include GDPR transparency wording for participants in your research application is changing.
In October 2024, we told you about new GDPR transparency wording templates we had developed for all sponsors, and the beginning of a transition period during which you should begin using this new wording.
This period has ended and you are expected to use the new GDPR wording in your IRAS submissions from today.
We have also received some questions and feedback from sponsors about how to use the template since it was published in October. We have listened to this and made some changes to the template to make it easier to use.
What is changing from 1 April?
All sponsors are now expected to use the new GDPR transparency wording template for any new research applications submitted via IRAS. This includes the leaflet about the use of confidential data in research, which is designed for patients and participants and provides more technical and detailed information in a layered way.
We will not accept the GDPR transparency wording we published in 2018 in any new submissions.
The current service to review bespoke GDPR transparency wording via commercial.gdprreviews@hra.nhs.uk has ended. Any bespoke wording which has already been submitted through this route will continue to be reviewed by us.
If you think there is a good reason why you cannot use this GDPR transparency wording template from 1 April and have developed your own, we will still review this on a case-by-case basis.
Why is this changing?
We have updated our GDPR transparency wording template to bring it in line with our Participant Information Quality Standards and the four principles for meaningful involvement of patients and the public in health and social care research.
We’ve made these changes so you can ensure that research participants have all the information they need to make an informed decision about the use of their data.
The changes to the template include more detailed information on how data is handled when it is sent abroad, as this is considered more important by members of the public than it was in 2018, and more detailed information on data subjects’ rights when their data is used in research.
What has changed in the template?
Since we published the updated template in October, we've had some feedback and have made some further changes. This includes:
- providing more information up-front about the type of organisations that process participants' information
- giving more information about the rights available to participants
- being clearer about how we expect the template to be used
What happens if I don't use the new wording?
The templates are designed to help you in your communications to research participants.
If you don’t use the templates, you will be expected to demonstrate how your own GDPR wording meets the four principles for meaningful involvement of patients and the public in health and social care research.
Read our guidance on the principles of meaningful involvement and our expectations for sponsors.
What happens if I have already submitted my study, or my study is ongoing?
There is no need to change the information in your participant information sheet to the new GDPR transparency wording. 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 previously approved and you want to update it, you should do one of the following:
- use our 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 our 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.
How do I access the template?
The GDPR transparency wording template is available on the HRA website.
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