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HRA Now - Updated GDPR Transparency Wording Template for all sponsors
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 What: we have refreshed the HRA's GDPR Transparency Wording Template
Who: anyone carrying out health and social care research in England, Wales, Scotland and Northern Ireland
When: from Wednesday 23 October 2024 (with a transition period ending on 31 March 2025)
What's changing
To help ensure research participants have all the information they need to make an informed decision about the use of their data the HRA has developed a series of GDPR templates that we recommend sponsors use.
The changes to the template include more detailed information on how data is handled when it is sent abroad, as this was 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.
The HRA’s Participant Information Quality Standards have also been updated with the removal of the standalone process for evidencing public involvement in the development of sponsor bespoke GDPR statements.
The new GDPR Transparency Wording Template is available to use in England, Wales, Scotland and Northern Ireland from today.
When should I start using the new template?
We are encouraging all sponsors to starting using the new template from Wednesday 23 October 2024.
You can use this template for new and open studies.
The use of this wording in open studies constitutes a non-substantial, non-notifiable amendment.
It does not require notification to the REC, national co-ordinating functions or the research management function of participating NHS or HSC organisations.
You should work with your research delivery teams to ensure participants receive this updated information.
Can I continue to use the HRA’s previous GDPR Transparency wording or previously approved bespoke sponsor wording?
Yes, there will be a transition period from 23 October 2024 to 31 March 2025 where you can continue to use previous wording or your own bespoke wording if it has been approved by the HRA.
For any new research applications submitted via IRAS from the 1 April 2025 you will be expected to either:
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use the new GDPR Transparency Wording Template for all sponsors
An associated change has also been made to the HRA’s Participant Information Quality Standards to bring them in line with these requirements. The previously numbered ‘quality standard 4’ has been removed, as the public involvement requirements in the development of bespoke GDPR statements are now captured within this process.
Any new bespoke wording submissions during the transition period will be dealt with on a case-by-case basis, but you will be asked to justify why you cannot immediately move to using the new GDPR Transparency Template Wording for all sponsors.
How has the HRA involved the public in developing its wording?
We have hosted a series of workshops when developing our new GDPR Transparency Wording Template for all sponsors.
The first, which took place in February 2023, involved patients, public and members of the research community, and informed the changes made to the content.
The second, which took place in September 2024, involved a community interest group called Expert Citizens. This informed the presentation and language used, to ensure it is accessible and easy to read and understand by members of the public with different individual experiences.
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HRA Now brings you important operational updates from the HRA - including changes to guidance or processes which might affect you. |
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