Announcements:
Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials):
From 1 January 2022 applications for all new CTIMP and IMP/Device trials must be made via the combined review service, which can be accessed using the new part of IRAS. It will not be possible to create new applications for CTIMP or IMP/Device trials on this system from 14 December 2021. If you are about to start a new CTIMP or IMP/Device trial application, please see the guidance on how to apply for combined review.
Radiation Assurance:
From 1 November 2021 any study involving ionising radiation, which is taking place in NHS/HSC secondary care settings, can apply for Radiation Assurance.
Eligibility Criteria for Student Research:
From 1 September 2021, there are new eligibility criteria for student research. Please visit the Health Research Authority (HRA) website – Student Research to review the new eligibility criteria and complete the Student Toolkit.
Pilot of coordinated assessment pathway for clinical investigations of medical devices:
The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to test a coordinated assessment pathway that will streamline the review of clinical investigations of medical devices. To find out more and register your interest visit the MHRA website.
Coronavirus / COVID-19 - key guidance for sponsors, sites and researchers
The Health Research Authority (HRA) website provides guidance about Research Ethics Committees (REC) and NHS/HSC arrangements and information about fast track review of COVID-19 research. For guidance relating to clinical trials of investigational medicinal products (CTIMPs) and medical devices please refer to the Medicines and Healthcare products Regulatory Agency (MHRA) website.
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Updates:
25 May 2021: IRAS updated to v5.20
This version includes updates to the MHRA Devices application to reflect the implementation of the EU Medical Devices Regulation in Northern Ireland. It includes changes to enabling of the form, questions, questions specific guidance and declarations / electronic authorisations.Please refer to the Updates page for more information.
9 March 2021: IRAS updated to v5.19
This version updates the wording of question A53 (how participants will be informed of results of research) and enables question A14-1 (public involvement in research) for all research studies. Please refer to the Updates page for more information.
21 December 2020:IRAS updated to v5.18
This version includes updates to questions and question specific guidance for studies involving medical devices. Please refer to the Updates page for more information.
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The Integrated Research Application System (IRAS):
- Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
- 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
IRAS captures the information needed for the relevant approvals from the following review bodies:
- 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
- Her Majesty's Prison and Probation Service (HMPPS)
- Social Care Research Ethics Committee
Please help us to improve IRAS by sending your feedback to iras.queries@hra.nhs.uk. Your comments and suggestions will be included in the next review of the system.
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