IMPORTANT: 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 and have not yet submitted your application, 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 use 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 will involve either ionising radiation or an investigational medical device, please refer to IRAS Help guidance.
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IMPORTANT: Eligibility Criteria for Student Research
Undergraduate Level:
Health and social care research applications from students working at undergraduate level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland.
Master's Level:
Applicants should complete the Student Research Toolkit in the first instance, to check eligibility. Some health and social care research applications from students working at Master's level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland.
Doctorate Level:
Health and social care research applications from students working at doctorate level are being accepted for Research Ethics Committee (REC) review; HRA and HCRW Approval; and/or Research and Development (R&D) study-wide review in Scotland and Northern Ireland. Applicants may find it helpful to complete the Student Research Toolkit.
Please visit the Health Research Authority (HRA) website – Student Research for further guidance. For student research below doctorate level, it is very important to complete the Student Research Toolkit before proceeding with your application form.
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If your research involves undertaking the research on the premises of a NHS/HSC organisation, with NHS/HSC patients or with NHS/HSC staff, then you should always contact the local NHS/HSC R&D office as early as possible.
All applications to conduct research in or through NHS/HSC organisations use the 'IRAS Form'.This involves a single electronic submission of the IRAS Form and associated supporting documentation. The process for submission is the same regardless of which UK nation the research is led from and whether or not NHS/HSC Research Ethics Committee (REC) review is required.
For more information about how to prepare and submit your application please refer to the
'Step by Step Guide'.
IMPORTANT: On 5 June 2019, the UK Local Information Pack brought in some key changes to the process and documentation for setting up NHS/HSC participating organisations.
Please refer to the UK Local Information Pack guidance for more information.
Guidance on how to apply to conduct research in NHS/HSC organisations and who to contact for further advice is based on where the lead NHS/HSC R&D office is located. For studies with sites in more than one UK nation, there are compatible arrangements across the UK to ensure that reviews applicable to the study as a whole are shared across all sites. Information should be provided to each NHS/HSC participating organisation in accordance with the guidance provided by the relevant nation (see relevant section below).
The guidance on this page is set out under the following sections:
For multi-centre research and single-centre research led from England or Wales you should electronically submit the IRAS Form according to the instructions provided in the step by step guide (see above).
For further information, researchers wishing to conduct research in the NHS led from England or Wales should refer to
Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval (‘HRA/HCRW Approval').
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For multi-centre research and single-centre research led from Northern Ireland you should electronically submit the IRAS Form according to the instructions provided in the step by step guide (see above).
For further guidance on seeking HSC R&D Permission in Northern Ireland please refer to
HSC website.
For further advice:
Contact the HSC R&D Office (details of offices are available via the
HSC website) or the Gateway (phone: (028) 7161 1126; email:
research.gateway@hscni.net).
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For multi-centre and single-centre research led from Scotland you should electronically submit the IRAS Form according to the instructions provided in the step by step guide (see above).
For further advice:
For further guidance on seeking NHS R&D Permission in Scotland please refer to the
NHS Research Scotland Permission Coordinating Centre website or contact the lead R&D office for advice.
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There are a number of errors that are often seen in applications. These may delay the progress of an application and in some instances may lead to the application being rejected. Below are some tips to avoid some of the common application errors:
- Project filter
- Make sure that you completed all the questions in the project filter and that your selections accurately represent your project. Incomplete or inaccurate selections will mean that the dataset you generate is not appropriate for your research.
- Questions in the dataset
- Make sure that you complete all fields in the form. You can review the form page by page online or create a pdf of your draft form.
- Supporting documents
- Make sure that you upload your supporting documents to the Checklist tab for the form. Documents uploaded in either Project Documents or My Documents areas are not automatically added to the form checklist. You should be ready with all relevant documents when you submit your application.
- The checklist provides a list of the documents that are normally expected to support the application. Use this as a guide to the documents you should include although those marked as mandatory are expected in all cases. Where you are not including a document that is listed, enter a reason in the "reason not supplied" box. Please note that there may be some additional documents that are not listed but which are applicable to your project. If you want to include a document that is not listed then add a row to include it by using the add row function at the bottom of the checklist.
- When you upload documents make sure you enter the correct file title, version number and date. Ensure that this information is consistent across the checklist and document. Where footers are used in documents please check that any document information is also consistent.
- Authorisations
- Make sure that you have electronic authorisations in place for all declarations in the form and that they are shown as valid.
- Do not add electronic authorisations until you are certain the application is complete. Any changes made to the dataset (except adding the booking reference number and date to page 1 of the form) will invalidate any authorisations that are already in place.
- If your form requires multiple authorisations be aware that if one of the authorisers changes the form before they authorise it then any authorisations that were already in place will be invalidated and will need to be sought again.
- Submitting your application
- You must book your application before you electronically submit it. If you do not book the application, it will be rejected and the submission history will show that your submission was invalid as no booking was made.
- If you change the content of the form and/or the documents in the checklist after submission, then these changes are not automatically sent and so you will need to liaise with your point of contact.
- After submitting your application
- Ensure that you or someone else familiar with the research is available to be contacted in the days after submission. This will enable quicker resolution of any queries about the application.
Applications will be assessed against a set of criteria and standards, which apply to NHS/HSC project-based research.
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On 5 June 2019, the UK Local Information Pack brought in some key changes to the process and documentation for setting up NHS/HSC participating organisations.
Please refer to the UK Local Information Pack guidance for more information.
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The Four Nations NHS/HSC Compatibility Programme is being undertaken for and supported by the UK Health Departments of England, Northern Ireland, Scotland and Wales. Further information about this programme is available at:
https://www.nhsresearchscotland.org.uk/services/uk-wide-working.
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Amendments(s) to all studies involving the NHS/HSC should be notified according to the
IRAS help guidance on amendments to research conducted in NHS/HSC.
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Page last updated: 28 February 2022