In this section, we share news about some of HRA’s work that we think you may be interested in. You might also enjoy exploring the news and updates section of the HRA website.
Facilitating a workshop at the launch of the HRA's strategy
The HRA has published two documents to improve information for people taking part in research:
From December 2023, both documents will be applied to all research applications submitted for review across the UK.
Why does this matter?
New approaches to care and new treatments can’t be developed unless people take part in research. Deciding whether to take part is a big decision. We call this ‘consent’. Consent is not valid unless people are properly informed and are not under pressure to decide.
There are two factors which seem to make the biggest difference to how well people understand and retain information about a study they have been invited to join:
- meaningful public involvement in developing participant information
- a high-quality consent conversation
So, in January this year we decided to:
- set minimum quality standards for participant information
- require public involvement in the design of participant information
- develop a framework for research teams and ethics committees to use
Who will use the documents, and how?
Both documents are freely available for anyone to use. We’ve tried to make them succinct and clear so they can be used by research teams, including members of the public involved in developing or reviewing participant information.
From December 2023:
- research ethics staff across the UK will review participant information to make a yes or no decision on whether the information meets the Quality Standards
- Research Ethics Committees will use the Design and Review principles as part of their ethics review. Applications that do not meet the standards and principles will receive a provisional rather than favourable opinion
What changes should you see?
It‘ll take a while for these documents to change people’s experience of being involved in or taking part in research. Future changes we expect to see include:
- in late 2023, if you’re working with researchers to develop or review participant information, we’d expect the principles to be used as a guide
- by early 2024, if you’re deciding whether to take part in research, the information you are given should meet the quality standards
How did we get to this point?
A lot of discussion, reading, writing, and re-writing brought us to this point. We want to thank everyone who took part in this project whether through responding to consultations; attending workshops to test out the draft principles; or steering the work as a member of the Think Ethics advisory group.
If you’re interested in this process, you can read more about it on our website.
If you’d like to share this news with people you work with, you can share this news story which has a summary and a link to the two documents.
If you have good examples of online information, videos and documents, do share these with our HRA Queries line on queries@hra.nhs.uk.
A discussion about public involvement at the launch of the HRA's strategy
The Health Research Authority (HRA) is working with the Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier for researchers to set up and run clinical trials in the UK.
One of the ways we’ll do this is by publishing guidance and other information about how best to involve patients and other members of the public in the design and running of clinical trials.
In the first instance, we want to highlight good information that is already publicly available. To do that, we have launched a short survey to ask people who design and run clinical trials what guidance and other information they already use and how it helps them. We’ll then include a selection of what is used most often in what we publish about patient and public involvement in clinical trials. Feel free to complete or share the survey.
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