What approvals are required?
What approvals are required?
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In order to undertake research in the NHS in England or Wales you need to obtain Health Research Authority (HRA) and/or Health and Care Research Wales (HCRW) Approval. Separate approvals are necessary in Scotland and Northern Ireland, you can find further information here: NHS/HSC R&D Permissions
HRA/HCRW Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, and independent ethical opinion (where required) by a Research Ethics Committee (REC).You need to submit an application via the Integrated Research Application System (IRAS).
A new step by step guide to make applications and manage projects through the combined review process (formerly known as Combined Ways of Working (CWoW)) is now available. As of 1 January 2022, combined review is the way all applications for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined IMP/device trials must be made. If you are a first-time user, please contact cwow@hra.nhs.uk for help to get started.
Implementation of online bookings for NHS/HSC study wide review and/or REC review:
An online booking service was rolled out as of Tuesday 19th May 2020. This service replaced the Central Booking Service (CBS) telephone line.
Applicants submitting research projects through IRAS will not need to call the CBS to book a REC review or to enable IRAS form submission. This can be done via the online booking service. The online system is available 24/7 and support is available by contacting 0207 104 8008 (Monday - Friday, 8.30am - 4.30pm).
Guidance on the online booking service is available via the IRAS updates page here and a short instructional video here.
When should I apply for HRA/HCRW Approval?
When should I apply for HRA/HCRW Approval?
The lead NHS R&D Office is in England or Wales.
The project is classed as research (see if your project is Research, service evaluation or audit), except when it falls under “research tissue banks” and “research databases” when only ethical review applies.
NHS premises and/or NHS patients and/or NHS staff in England and/or Wales are participating in the research.
Student Research
Student Research
Guidance on criteria for student research and approvals can be found on the HRA website.
Support with IRAS Applications
Support with IRAS Applications
Some top tips on how to write and submit your application for HRA/HCRW Approval can be found under 'tips for a successful application'.
Visit the HRA 'planning and improving research' section to ensure your application is 'right first time'.
The R&D Office at Norfolk and Waveney ICB can also provide advice and guidance on applying through IRAS if your study will be taking place in Primary or Community Care in the East of England Region.
Please ensure that your IRAS application includes the relevant site(s) where your study will be taking place in Part C of the IRAS form – please contact us for more guidance.
Local Confirmation of Capacity and Capability
Local Confirmation of Capacity and Capability
When HRA/HCRW Approval is in place, depending on the study type and HRA assessment, the local organisation(s) undertaking your study will need to confirm capability and capacity to undertake your research. The R&D office will assist with the confirmation of local capacity and capability when required. We will advise, when required, on regional requirements e.g. laboratory analysis, IT arrangements and liaise with local Trusts and ICBs to secure these. Please note, you will not be able to start your study at the site(s) if local capacity and capability is required and its confirmation is pending.
This diagram shows the steps in the HRA/HCRW Approval process.
This diagram shows the steps in the HRA/HCRW Approval process.
Make sure that you keep the local R&D and sites updated throughout the approval process. Should you have any questions on HRA/HCRW Approval processes and confirmation of local arrangements please contact us at NWICB.RandDoffice@nhs.net.
Should you wish to make an amendment to the study after HRA/HCRW Approval has been granted please click here.
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