An image of researchers discussing public involvement at a table

The Health Research Authority launches new standards to improve research information for participants

What: information about new the Health Research Authority (HRA) Quality Standards and Design and Review Principles for participant information materials 

Who: all applicants and sponsors submitting new research applications

When: new applications submitted on or after 01 December 2023  

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 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 please note:

  • 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.

Visit the HRA's website to read the frequently asked questions

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. 

The HRA acknowledges there is already a lot of good work in this area, both in the UK and globally, but to date this has not 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.

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 familiarise yourselves with the Quality Standards and the Design and Review Principles and notify your research teams across your organisation who are involved in preparing participant information.