Guidance
We’ve updated our guidance on the HRA website and the Integrated Research Application System (IRAS) Help platform.
For specific information on what has changed for CTIMPs, read our clinical trials regulations guidance.
To find out more about what has changed for non-CTIMPs, read our guidance on changes to non-CTIMP clinical trials and other research.
You can also read the MHRA’s clinical trials regulations guidance, which has been updated and added to over recent months, on their clinical trials hub.
Simplified arrangements for consent principles published
The updated clinical trials regulations offer sponsors of clinical trials that meet certain conditions the option to use simplified arrangements for seeking and evidencing informed consent.
We’ve been working with an advisory group to help us develop principles that will support sponsors and research team members to use simplified arrangements when seeking and evidencing informed consent in low intervention clinical trials.
These principles are intended to support proportionate approaches to the information provided to participants, the conduct of consent discussions, and the methods used to evidence consent, ensuring that consent remains informed, freely given, and explicit.
The principles have now been published and are available on the HRA website.
We will work with you to understand how these new arrangements can help you do to your research in a way that people can trust. Please do This email address is being protected from spambots. You need JavaScript enabled to view it. with your ideas for how to apply these arrangements to your studies.
Model research agreements
Our updated suite of model research agreements should be used from today.
The updated agreements include commercial and non-commercial site agreements and the commercial chief investigator agreements.
The complete list of updated agreements is available on the HRA website.
Modification Tool
The Modification Tool, an updated version of the Amendment Tool, is now fully functional.
Sponsors and researchers should use the tool as part of the process for submitting modifications from today.
We've made further updates to the tool's functionality and guidance based on early feedback following its launch earlier this month. Please keep on This email address is being protected from spambots. You need JavaScript enabled to view it. so that we can continue to make improvements.
CTIMP protocol template
Sponsors and researchers should now use the updated protocol guidance and template for use in a CTIMP.
The guidance and template document is designed to support sponsors and researchers when developing a research protocol and has been updated to reflect the changes to clinical trials regulations.
Governance Arrangements for Research Ethics Committees (GAfREC)
The Governance Arrangements for Research Ethics Committees (GAfREC) has been updated and renamed the UK Research Ethics Committee (REC) Policy Document.
The document sets out when review by a REC is required and what’s expected from committees reviewing health and social care research applications.
Policies, procedures and standards
Working in partnership with the UK health departments in Northern Ireland, Scotland and Wales, we’ve also updated the following policies, procedures and standards in line with the amended clinical trials regulations:
Support
We know there are lots of changes to navigate, so please do get in touch if you have any questions or if you need support with our updated processes and systems.
If you have any questions about the changes to the regulations or our guidance, please contact our This email address is being protected from spambots. You need JavaScript enabled to view it..
For technical queries, for example when using IRAS or to provide feedback on our systems, please get in touch with our This email address is being protected from spambots. You need JavaScript enabled to view it..
For an overview of all the regulatory changes, watch the HRA and MHRA’s ‘Clinical Trials Regulations: Countdown to Implementation’ webinar, held in March.
HRA and research news
Interested in finding out more about the HRA and our work? We have a range of different newsletters to suit your interests.
HRA Latest – a monthly newsletter to keep you up-to-date with our latest news and developments
HRA Now – an operational bulletin aimed at those working in and supporting the set up and delivery of research
HRA public involvement newsletter – news and information about public involvement in health and social care
Building better research services newsletter – the latest information on our work to improve the digital services used in the UK to plan, manage and deliver health and social care research
If you would like to find out more about health and social care research and opportunities to get involved in studies, sign up to the National Institute for Health and Care Research (NIHR) newsletters.
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