Improving information for people taking part in clinical research

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research governance, research integrity, Research news

The Health Research Authority (HRA) has launched new Quality Standards to improve information given to people who are invited to take part in research. 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.

  • The new HRA Participant Information Quality Standards will help research organisations to understand what good participant information looks like, and will make clear to researchers what the Research Ethics Committees will consider as part of the ethics review, including the review of participant information. The REC will support researchers 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 documents set out the basic criteria that all participant information must meet, and covers language, accessibility, and mandatory content.

Next steps

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.

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.

Available templates

Remember that BU has Participant Information Sheet templates that provide much of the required wording to ensure your participants are making a fully informed decision before agreeing to participate.

It is vital that when compiling your information sheets that you remember to include the HRA GDPR transparency wording.

Questions or concerns?

If you have any questions regarding these new standards or about clinical research in general, please email Suzy Wignall, Clinical Governance Advisor – swignall@bournemouth.ac.uk or clinicalresearch@bournemouth.ac.uk

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