What approvals are required?

What approvals are required?

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 only need to submit one application via the Integrated Research Application System (IRAS).

NEW! Implementation of online bookings for NHS/HSC study wide review and/or REC review:

A new online booking service was rolled out as of Tuesday 19th May 2020. This service replaces the existing Central Booking Service (CBS) telephone line.

Applicants submitting research projects through IRAS will no longer need to call the CBS to book a REC review or to enable IRAS form submission. This can now be done via the online booking service. The online system will be available 24/7 and support is available by contacting 0207 104 8008 (Monday - Friday, 8.30am - 4.30pm).

The guidance on the new online booking service is available via the IRAS updates page here and a short instructional video here.

Applicants making contact about fast-track COVID-19 studies, should continue to follow HRA current guidance or email fast.track@hra.nhs.uk, DO NOT use the online booking service.

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.

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 CCG can also provide advice and guidance on applying through IRAS if your study will be taking place in Primary or Community Care in the Eastern 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

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 CCGs 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.

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 NWCCG.RandDoffice@nhs.net.

Should you wish to make an amendment to the study after HRA/HCRW Approval has been granted please click here.