Announcements:

The updated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 are now in force

For further details please visit www.hra.nhs.uk

Update to the modification (amendment) tool

The new Modification Tool (Version 2.1) became fully operational on 28 April 2026.

The tool reflects the new modification types in the regulations, which apply to clinical trials of investigational medicinal products (CTIMPs).Non-CTIMP studies will also adopt the same terminology and modification categories.

Research involving an in vitro diagnostic device (IVD):
Currently, different EU regulation applies to studies that involve a performance evaluation of an IVD taking place in Northern Ireland compared to the rest of the UK. To find out more about these regulations and what it means for your research application we have produced some guidance to help.

Confidentiality Advisory Group (CAG):
All CAG applications are now booked and submitted by email only. If you are applying via the full review pathway you will be invited to attend the review meeting via Zoom. Refer to the IRAS Help guidance for more information.  

04 February 2025: IRAS updated to v6.4: This version updates the questions and guidance to align with the NIHR Research Delivery Network (RDN) which replaced the NIHR Clinical Research Network (CRN) on 01 October 2024. Please refer to the Updates page for more information.

17 October 2024: IRAS updated to v6.3.9: This version gives users the ability to delete unsubmitted projects from the ‘My Projects’ section of IRAS. Please refer to the Updates page for more information.

26 September 2024: IRAS updated to v6.3.8: This version implements an increase in the post approval statuses that applicants can receive on the e-submission page of the IRAS form. Please refer to the Updates page for more information

• Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
• Generates the IRAS ID, which has been adopted by stakeholders across the UK as the common study identifier
• Enables you to enter the information about your project once instead of duplicating information in separate application forms
• Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
• Helps you to meet regulatory and governance requirements

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Confidentiality Advisory Group (CAG)
• Gene Therapy Advisory Committee (GTAC)
• Health Research Authority (HRA) and Health and Care Research Wales (HCRW) for projects seeking HRA & HCRW Approval
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• HM Prison and Probation Service (HMPPS)
  
• Social Care Research Ethics Committee