HRA REC approval process

(Information is based on version 5.10 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.

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

Combined review is the way research teams seek approval for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined medicine and device trials. Research teams make a single application using a new part of IRAS, which goes to both the Medicines and Healthcare products Regulatory Agency (MHRA) and a research ethics committee (REC) at the same time. The application also goes for study wide review, such as HRA and HCRW approval, if the study is to take place in the NHS or Northern Ireland HSC. The regulatory and ethics reviews are done in parallel and any requests for further information (RFIs) are raised jointly. A single response to these requests leads to a single decision from both reviews. Study wide review is usually issued at the same time as MHRA and REC, but may come later if there are still issues to discuss with the applicant.

The form is similar to IRAS in that it filters depending on the answers given. Details on how to access CWOW and how to use the form can be found on the HRA website CWOW guidance

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.

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.

Booking and submitting application

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.

To book an ethics meeting for a non-CTIMP study use the online booking service. For CTIMP studies once the Sponsor or Sponsor Delegate has confirmed the submission, the user who sent the request will receive a task in their 'My outstanding tasks' list to 'complete the REC booking'. Selecting this task will take you to the REC booking page. This page provides a list of previous bookings and instructions for booking your REC.

To book using the online booking service, applicants should select 'create booking'.

The REC booking page also provides instructions on what to do if you have booked your REC manually via telephone (or e-mail). For manual bookings it is important to remember to import the REC booking details into your project manually to link the booking with the application.

After you have made a booking:

• You will receive an email confirming your booking and REC reference number. You will need to return to the application form in IRAS and add the REC name, REC reference number, and submission date at the start of the form.
  Important: Take care not to amend or click in any other fields as this will invalidate your application. Data entry in the REC details fields in IRAS will not invalidate your electronic authorisations, however please note that if you alter any other part of your application electronic authorisations will be invalidated. 
• You must then electronically submit your application. This must be done on the same day as making your booking. Return to the form’s e-submission tab and click ‘e-submit application’.

If your study has been submitted for Proportionate Review, a member of HRA staff will undertake a thorough pre-screen to check that the application is eligible. If your application is better suited to a Full REC review – because it does not meet the criteria for proportionate review – you will be contacted within two working days and arrangements will be made for the application to be transferred.

The receiving REC Manager decides whether or not your application is valid. The notification for this decision is normally issued within 5 working days or within 2 working days for application submitted for proportionate review. If your application is correct and valid, you will be issued a validation letter within this period, acknowledging your submission and confirming it is valid.

In the meantime, HRA may issue an initial assessment letter. You can apply to NHS sites using the HRA initial assessment letter along with their local document pack.

Projects which are going through full review, will receive a letter confirming REC meeting and venue details. You have an opportunity to attend this meeting.

Between seven and 15 members of the REC will be present at the meeting, together with the REC manager. It is a formal committee meeting, but the REC will wish to make this a positive and helpful experience. 

The committee will ask you questions surrounding ethical issues arising from your application in order to seek reassurance that all ethical issues have been addressed, and so you should be ready to provide clarification in respect of any ethical issues. It is helpful if you have a copy of your application form and study documents with you to refer to when you attend the meeting. 

If your study forms part of an academic qualification then we strongly advise that your academic or clinical supervisor attends the meeting with you. This gives the REC the opportunity to clarify any points directly with your supervisor. 

The Committee must notify you of their decision within 60 calendar days of receiving your valid application and 21 days for studies accepted for proportionate review.  After meeting, you will be notified of the REC’s decision, usually within 10 working days. The REC can reach one of the following decisions about your application:

Application reviewed at a full meeting:

• Favourable opinion
• Unfavourable opinion
• Provisional opinion with request for further information
• Provisional opinion pending consultation with a referee

Application reviewed by sub-committee under proportionate review:

• Favourable opinion
• Unfavourable opinion
• Provisional opinion with request for further information
• No opinion – application referred to full meeting

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.

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, HRA 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:

• You also need to obtain sponsor approval prior to submission to HRA/REC for any amendments
• Apply to the REC for approval of any substantial amendments to the protocol 
• 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