9th October 2023

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: applicants and sponsors submitting new research applications, which include participant information materials

When: available for use from September 2023, mandatory for submission from December 2023

What are the Quality Standards and Design and Review Principles? 

The HRA has launched the new Quality Standards and Design and Review Principles to improve the information given to people who are invited to take part in research.

The Quality Standards set out what good participant information looks like. The Design and Review Principles explain to research organisations how to achieve the Standards and how Research Ethics Committees (REC) will check whether the standards have been achieved.

The Quality Standards will be applied UK-wide by research ethics staff who will check if the participant information is compliant when a research application is validated for the research ethics review. Their findings will be included as part of the outcome from the REC meeting, alongside feedback from the ethics review undertaken by the REC.

The HRA is encouraging research organisations to be aware of the new Quality Standards and Design and Review Principles so that they can design participant information in line with the new requirements when submitting new applications.

This will also help research organisations to meet the Standards before they become mandatory later this year.

The Quality Standards and the Design and Review Principles were developed jointly with REC members, researchers, research participants, patients, and the public to streamline and improve information for participants and the research ethics review. They are based on an extensive review of published literature and evidence on information for research participants.

Action and next steps 

As study materials are prepared in advance, the Quality Standards and Design and Review Principles will be phased in from September 2023, to enable sponsors and researchers to familiarise themselves with the documents.

From September any findings which are beyond the scope of previous expectations for participant information materials will be presented as recommendations within the REC outcome.

From December 2023, the Quality Standards and Design and Review principles will become mandatory and will be applied to all research applications submitted for review. Applications that do not adhere to the guidance will receive a provisional opinion.

The HRA know that changes to participant information are currently the most likely reason for ethics committees to give a provisional opinion. Using the new Quality Standards and Design and Review Principles will increase the possibility of receiving a favourable opinion.

Please ensure you familiarise yourselves with them and notify your research teams across your organisation who are involved in preparing participant information.

Find out more information by reading the Quality Standards and the Design and Review Principles.