Announcements: Sharing amendments with HSC organisations in Northern Ireland: From the 31st March 2025 the process for sharing amendments with participating HSC organisations in Northern Ireland has changed. The process for Northern Ireland has now aligned with the process for sharing amendments with NHS organisations in England and/or Wales. For further information refer to our guidance on IRAS help. Update to the Amendment tool: On the 31st of March 2025 the amendment tool, which is used to categorise and submit amendments to project-based research studies, was updated. Version 1.7 of the amendment tool is now available on IRAS help. If you're preparing or submitting an amendment to a project-based research study from the 31st of March 2025 you should use version 1.7 of the amendment tool. 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. 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. |