Updated clinical trials regulations came into force today (28 April 2026).
We’ve made some operational and guidance updates to support the research community and to make sure our policies, processes and systems are in line with:
- the updated regulations, which apply to clinical trials of investigational medicinal products (CTIMPs)
- associated UK-wide policy changes for non-CTIMP clinical trials and other types of research
Guidance
We’ve updated our guidance across 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.
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 published principles that will support sponsors and research team members to use simplified arrangements when seeking and evidencing informed consent in low intervention clinical trials.
Read more about the new principles.
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.
Read our news story for more on the agreements, including the full list of updates.
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. Please keep on sending us your feedback so that we can continue to make improvements.
Read more about the Modification Tool.
CTIMP protocol template
Sponsors and researchers should now use the updated protocol guidance and template for use in a CTIMP.
The guidance and template is designed to support sponsors and researchers when developing a research protocol, and has been updated to reflect the changes to clinical trials regulations.
View the CTIMP protocol guidance and template.
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.
Governance Arrangements for Research Ethics Committees
The Governance Arrangements for Research Ethics Committees (GAfREC) has been updated and renamed the UK REC Policy Document.
The document sets out when review by a Research Ethics Committee (REC) is required and what’s expected from committees reviewing health and social care research applications.
Read more about the changes in the updated UK REC Policy Document.
Policy Framework for Health and Social Care Research
This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK.
REC Standard Operating Procedures
The standard operating procedures (SOPs) for RECs set out the requirements they must meet when reviewing research applications and when giving an opinion on whether the research is ethical.
The SOPs have been updated to reflect the change in REC membership, terminology, timelines and REC decisions.
We’ve also updated the accompanying summary of changes document.
Read the REC Standard Operating Procedures and a summary of changes.
UK study-wide governance criteria
The study-wide governance review criteria describe the standards against which research applications are reviewed in all 4 nations of the UK.
Updates to the criteria include terminology changes, new guidance relating to the principles of simplified arrangements for seeking and evidencing informed consent, and updated guidance on who can be a chief investigator.
Read the criteria and the summary of changes.
CTIMP Standard Conditions
This document sets out important guidance for sponsors and investigators on the conduct and management of CTIMPs following ethical review.
Read the CTIMP Standard Conditions.
Non-CTIMP Standard Conditions
This document sets out important guidance for sponsors and investigators on the conduct and management of research with a favourable opinion from a REC.
Read the non-CTIMP Standard Conditions.
Research Database Conditions of REC Favourable Opinion
This document sets out the conditions for projects given a favourable opinion by a REC for the processing of personal data by research database teams.
Read the Research Database Conditions of REC Favourable Opinion.
Research Tissue Banks Conditions of REC Favourable Opinion
This document sets out the conditions for research tissue banks given a favourable opinion by a REC.
Read the Research Tissue Banks Conditions of REC Favourable Opinion.
Pre-election period in Scotland and Wales
The new clinical trials regulations apply across the 4 UK nations. Promotion of the new regulations may be impacted by the pre-election period in Scotland and Wales. In the first instance you can find the latest information about clinical trials on the HRA website or at Medicines: clinical trials hub - GOV.UK