The Health Research Authority (HRA) has launched new Quality Standards to improve information given to people who are invited to take part in research.
Research organisations provide information about their studies to help people decide if they would like to take part.
The new HRA Participant Information Quality Standards will help research organisations to understand what good participant information looks like.
The Quality Standards have been launched alongside Design and Review Principles, which show researchers and Research Ethics Committees (REC) what the important ethical considerations are for participant information.
They also make clear to researchers what the RECs will consider as part of the ethics review, including the review of participant information and will support them to create information that meets the Quality Standards.
The aim of the Quality Standards and Design and Review Principles is to make participant information better and to make the way that RECs review that information more consistent.
The Standards set out the basic criteria that all participant information must meet, and cover language, accessibility, and mandatory content.
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 of the ethics review meeting which is 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.
This will also help research organisations to meet the Standards before they become mandatory later this year.
Jonathan Fennelly-Barnwell, Deputy Director of Approvals at the HRA.
'It’s really important that participant information is easy to understand. Choosing to take part in research is a big decision and people need to understand any risks involved in the research, as well as the benefits.
'But while some research organisations provide good quality information, too often participant information is provided in a way that is confusing and difficult to understand. This includes using legal language, long-winded sentences, and complicated medical terms.
'Our new policies will help to make participant information better, by providing guidance to researchers on what good participant information should look like. They will also help RECs make decisions about participant information in a more consistent way.
'This will mean more people will be able to make better decisions about whether to take part in research. This will make participant recruitment and retention more efficient and ultimately lead to more successful research.'
The Quality Standards and Design and Review Principles will be phased in from autumn 2023. As study materials are prepared in advance, REC reviews of participant information will initially be presented to research organisations as recommendations as opposed to actions required for approval.
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.
We are making the Quality Standards and Design and Review Principles available on the HRA website now, so research organisations can start preparing participant materials in line with the new requirements.
We know that changes to participant information are currently the most likely reason for ethics committees to give a provisional opinion. Using this guidance will increase the possibility of receiving a favourable opinion. From December 2023, applications that do not adhere to the guidance will receive a provisional opinion.
Research ethics staff and REC members are being given support and training on how to apply the Quality Standards and Design and Review Principles.
We want to share good examples of online information, videos and documents. We will ask applicants if they are willing to share some or all of their content more widely. If you have any queries or good examples to share, we’d love to hear from you – please get in touch via the HRA Queries line.
How we developed the standards and principles
The Quality Standards and the Design and Review Principles were developed jointly with REC members, researchers, research participants, patients, and the public.
The Quality Standards and the Design and Review Principles are also 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.
We understand that sometimes the participant information for a research project is prepared in another country. We encourage applicants to signpost colleagues in other countries to our guidance, as it is relevant anywhere in the world.