This page provides you with instructions on how to apply for HRA Research Ethics Committee (REC) approval for your research via the Integrated Research Application System (IRAS).

Please also refer to the SOP on NHS REC approval Standard Operating Procedures section. 

How to apply for NHS REC approval

Complete the online application form

(Information is based on version 5.1 of the online form)

All applications must be made using the IRAS online application form which can be accessed at the IRAS website . If you are a first time user, you will need to register for an account online, which is activated immediately.

You do not have to complete the application form in one go - work can be saved and reloaded for further editing.

The form is designed to save you time completing it. When you fill in certain answers, information will auto-populate in other relevant places and your answers to certain questions will deactivate or activate other sections of the form.

As a result, you are never likely to complete every single page - the average is around 20 pages long.

The application form is structured as in the table below. You may also find a breakdown of each question topic useful.

Part

Details

Form Filter

Asks a limited number of key questions about the nature of your research. An application form specific to your project will be created from the answers you give. You need to select your answers carefully.

A

Asks for generic information relevant to all research proposals. Certain questions will be deactivated depending on your answers to the form filter.

B

Is divided into several discrete sections, which refer to particular specialist topics. These appear (or disappear) in response to your answer the form filter.

C

Asks for information required for Site Specific Information form (SSI), including the suitability of the site chosen and of the research team at that site. Part C will need to be completed with the PI at each locality, see para. 7 on SSI below.

More detailed information about using the form is available through the 'help' pages on the IRAS website.

Complete the applicants checklist

You must also complete the 'Applicant's Checklist' to ensure that all of the paperwork required to support your application is sent to the REC.

You can access the checklist online through the IRAS  system. A different version of the checklist must be completed depending on the type of your research; there is one for CTIMPs and another for any other research in the NHS.

The online system automatically generates the relevant checklist depending on your answers to the form filter. You must ensure you have the appropriate copies of any supporting documentation, as outlined in the Checklist.

Decide where to apply/ book an agenda slot

The IRAS system will provide guidance on how to book an ethics committee slot.  The current guidance is listed below but is subject to change.


Type of Project

NHS REC Booking Route

CTIMP or device trial

Apply via the CAS
Tel: 0845 270 4400 (9.30 a.m. to 4 p.m. weekdays)

All other health-related research that is multi-site AND in more than one NHS domain

Apply via the CAS
Tel: 0845 270 4400 (9.30 a.m. to 4 p.m. weekdays)

All other health-related research that is ONLY in one NHS domain (can be either single or multi-site)

Apply direct to your local REC (or exceptionally via the CAS if the study is likely to be extended beyond the domain).
For multi-site studies, you can approach the LREC for the lead site.

Any project which involves prisoners

Apply via the CAS
Tel: 0845 270 4400 (9.30 a.m. to 4 p.m. weekdays)

Submission

Once you have booked an agenda slot via IRAS, you should be sent confirmation of your booking by email, together with a unique IRAS reference number and the closing date for your application.

You must make sure you add the IRAS reference number to your online application form at this point; it should be inserted in the header section of Page 1 (along with the name of the NHS REC and the submission date).

You then need to 'lock' your form and save it as a pdf by using the 'print' button on the system.

For bookings through the CAS, you will need to submit Parts A and B of your application electronically to the REC that you have been allocated within 4 working days of your booking. For local applications, you may be required to submit within 4 working days of your booking or at another specified time before the meeting.

You also need to send the REC office the following in paper copy by the closing date:

  • Application form, with signatures in ink
  • Applicant's Check List
  • All relevant supporting documents, as indicated on the Checklist

Validation

If your application is correct and you have submitted it with all the relevant documents by the closing date, you will be issued a validation letter within 5 working days, acknowledging your submission and confirming it is valid.

Site Specific Information form (SSI)

If your research is multi-site, once you have received the validation letter, you can instruct the PIs at each site to apply for SSI.  Each PI should complete Part C of the completed application and submit it to their R&D Office together with the study documents.

Notification of decision

The Committee must notify you of their decision within 60 days of receiving your valid application.

The REC can reach one of three decisions about your application:

  • Final decision - which could be favourable or unfavourable
  • Provisional decision - with a request for further written information
  • No opinion - as a referee needs to be consulted

You should receive notification of the decision within 10 working days of the review meeting.

Request for further written information

The REC may make a provisional decision about your research and ask for further information about specific aspects of the project. Such a request can only be made once and the 60 day clock stops whilst the REC awaits your response.

If your response is not deemed satisfactory, the committee may ask you to respond again to the same questions (no new issues can be raised) or reject your application.

The clock only starts again when a complete response is received. A final decision should then be issued.

After approval

Once you have received NHS REC approval, you must not start your research until you have all the relevant regulatory approvals e.g. MHRA, CAG sponsor approval and R&D approval from the relevant NHS Trust(s).

Your research must start within 12 months of the date on which a favourable opinion was given.

A study is generally considered to have commenced when the first subject gives written informed consent to participate or, where this does not apply, when any procedures in the protocol are initiated.

If your research does not commence within 12 months, a substantial amendment will have to be submitted to the REC (and if it does not start within 24 months, you will have to re-apply).

After approval, you will also need to:

  • Apply to the REC for approval of any substantial amendments to the protocol - this includes any changes to the end date from that specified in your application
  • Provide appropriate safety reports
  • Apply to the relevant R&D Office of any subsequently enrolled research site
  • Provide an annual progress report to the main REC each year of the project's duration
  • Inform the REC when the project finishes using the end of study declaration form