Implementation of the Quality Standards and Design and Review Principles
The Participant Information Quality Standards and Design and Review Principles were launched in September 2023 to improve information given to people who are invited to take part in research.
Since then, to allow applicants time to become familiar with the new requirements, staff and Research Ethics Committee (REC) Members have been providing feedback on areas of non-compliance as recommendations.
From Friday 1 December 2023 all applications submitted will need to comply with the new requirements.
Following feedback and engagement with researchers and sponsors, we would like to draw your attention to the following:
- The Quality Standards and Design and Review Principles apply to new application submission only, and will not be applied to amendments involving participant information in ongoing studies.
- The Quality Standards will be used by research ethics staff during the research application validation stage to check if the participant information is compliant. Your application will not be rejected at validation if it is not compliant. Any findings will be considered by the REC as part of its ethical review. Where changes or requests for further information are required, they will be included as part of the review outcome from the REC meeting.
Public involvement in participant materials
The Quality Standards and Design and Review Principles reference public involvement in the development and review of information materials. UK study-specific public involvement activities are not required for every submission, if previous activities are relevant to a new submission. This includes global public involvement activities or activities that take place on a broader level.
We know that there is already a lot of good work in this area, both in the UK and globally, but to date this has not always been described in detail or with relevance to the study application. Please ensure you describe the activities that have been done and how they link to your application.
You can find out more about meaningful public involvement on our website.
Action and next steps
From Friday 1 December 2023, the Quality Standards and Design and Review Principles will be applied to all research applications submitted for review.
Applications that do not adhere to the Standards and Principles will receive a provisional opinion from REC.
Please ensure you familiarise yourselves with them and notify your research teams across your organisation who are involved in preparing participant information.
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