Announcements:

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. 

Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials):
It is no longer possible for a new CTIMP or IMP/Device trial application to be made using this part of IRAS. If you have an existing CTIMP or IMP/Device trial project that has not yet been submitted, you will no longer be able to do so here.

All CTIMPs and IMP/Device trials now need to apply using the combined review service, which can be accessed using the new part of IRAS. Please refer to the guidance on the HRA website for instructions on how to apply for combined review. If you have any queries related to applying for combined review please contact cwow@hra.nhs.uk. If your combined review application involves ionising radiation and/or an investigational medical device, please refer to IRAS Help guidance.

MHRA notification scheme - you should check if your trial meets the criteria for the new notification scheme. If it does, follow the instructions on the MHRA website to register your interest. Trials eligible for the MHRA's scheme, may also be eligible for fast-track REC review service, and applications are submitted through combined review.

Ionising radiation form for combined review: The ionising radiation form for combined review has been simplified. Refer to the IRAS Help guidance 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

08 July 2024: IRAS updated to v6.3.7: This version implements updated links to the new applications portal for ARSAC applications. 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