An update from our simplified arrangements for consent advisory group
The amended clinical trials regulations will offer sponsors of certain low intervention CTIMPs, which meet defined criteria, the option to use simplified arrangements for seeking and evidencing informed consent.
In October 2025, we brought together an advisory group to develop a set of principles that will help sponsors and researchers when designing and implementing simplified arrangements in these type of trials.
The principles are designed to make sure that consent processes remain clear and proportionate, reducing unnecessary steps and duplication while maintaining trust in research.
Kirsty Edwards and Joanne Lloyd, co-facilitators of the advisory group, have written a blog updating on the work of the group and the principles.
Coming soon
Launch of updated Amendment Tool
We’re releasing an updated version of the Amendment Tool on the Integrated Research Application System (IRAS) ahead of the regulations coming into force.
The tool is used by sponsors and researchers to categorise amendments and provide guidance on which review bodies the amendment should be sent to, based on the changes that are being made to a study.
The new version of the tool will be renamed the Modification Tool and updated to reflect the change in terminology from ‘amendment’ to ‘modification’ and the new modification categories:
- substantial modification
- modification of an important detail
- minor modification
The Modification Tool will be available on IRAS from the end of March for information purposes only so that sponsors and researchers have time to familiarise themselves with the updates. The tool will go live on 28 April 2026 and will accept submissions from that date.
We’ll let you know when the updated tool is launched.
Update to the suite of model research agreements
We’ll soon be publishing our updated suite of model research agreements, including non-CTIMP agreements. We invited feedback on our draft model Clinical Trial Agreement (mCTA) and the related suite of commercial template agreements in the UK late last year.
We’ve been working through the feedback and plan to publish the updated suite in the next few weeks.
We’ll share more on this soon in our Clinical Trials update as well as HRA Now, our operational bulletin, which is aimed at those working in and supporting the set up and delivery of research.
CTIMP protocol template
The CTIMP protocol template, designed to support sponsors and researchers when developing a research protocol, is also being updated to reflect the amended clinical trial regulations.
This will be available on the HRA website by the end of March.
MHRA new and updated guidance
The MHRA has published new guidance on Good Manufacturing Practice (GMP) for investigational medicinal products (IMPs) used in clinical trials.
They have also updated existing clinical trials regulations guidance on their clinical trials hub and have published information relating to ICH E8 UK-specific annotations.
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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