We’ve launched new Quality Standards and Design and Review Principles to improve information for people invited to take part in research. They will be implemented UK wide and will become mandatory from 1 December 2023.
To help organisations prepare, we’ve created a list of frequently asked questions. We'll be adding to this page so look out for further updates.
What are the Quality Standards and Design and Review Principles?
The Quality Standards set out the minimum criteria that all participant information must meet.
The Design and Review Principles explain to research organisations how to achieve the standards and how Research Ethics Committees (RECs) will check whether the standards have been achieved. This will also help to ensure that the way RECs review participant information is more consistent.
How will they be checked?
The Quality Standards will be used by research ethics staff during the research application validation stage to check if the participant information is compliant. Their 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.
The Design and Review Principles will be used by RECs during the ethics review process.
For research applications submitted for HRA and HCRW Approval only (those which do not require REC review), participant information will be checked by study-wide reviewers at the validation stage.
What happens if we don’t meet the new Quality Standards and Design and Review Principles?
From 1 December 2023, applications that do not adhere to the new requirements will receive a provisional opinion. Using the Standards and Principles when developing participant information will increase the possibility of receiving a favourable opinion.
Will the Standards and Principles only apply to new application submissions?
Compliance with the Standards and Principles will be compulsory for all applications which are submitted from 1 December 2023. As study materials are prepared in advance, applications submitted for review from September 2023 will be checked for compliance, but the REC review of that information will be presented to research organisations as recommendations as opposed to actions required for approval.
Will the Standards and Principles apply to applications that have already received a favourable opinion?
Existing research applications which have already received a favourable ethical opinion prior to this will not be expected to revise participant information which are already in use to align with the new requirements. This is because the favourable ethical opinion which was previously issued remains valid. However, we would welcome researchers taking the new guidance into consideration when making wider necessary changes to existing participant information to bring it in line with the new requirements.
Do I need to do anything ahead of the 1 December 2023?
Review the Quality Standards and Design and Review Principles, which we’ve published on our website to help organisations to prepare.
Why were the Quality Standards and Design and Review Principles developed?
The Standards and Principles were developed as part of our Think Ethics programme to make the participant information materials better by providing evidence-based guidance to researchers on what good information should look like. The Principles will help make REC decisions about participant information more consistent.
How were the Quality Standards and Design and Review Principles developed?
The Quality Standards and the Design and Review Principles were developed jointly with REC members, researchers, research participants, patients, and the public as part of our Think Ethics programme.
They are based on a comprehensive review and analysis of the evidence on participant information.
We conducted a thorough and extensive public consultation on the new criteria involving more than 200 people and we analysed the feedback received to develop them.
What are the benefits to research participants?
Developing better quality participant information materials, created with meaningful public involvement, will provide people with the right information to make informed decisions around whether to participate in research.
What are the benefits to research community?
The Quality Standards and Design and Review principles will help make it easier for researchers to provide better participant information. This will make participant recruitment and retention more efficient and inclusive and ultimately lead to more successful research. They will also help to ensure that there is more consistency in how RECs review participant information. Compliance with the Standards and Principles will increase the possibility of receiving a favourable ethical opinion.