(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.

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.

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.

Once the operator has agreed the meeting slot with you, the operator will check that you are ready to submit the application and all supporting documentation are ready before accepting the booking. After the call you will receive an email confirming your booking and REC reference. You are expected to enter the details of the name of the REC and the REC reference at the start of the REC application form in IRAS. Please note that this entry will not invalidate the electronic signatures but any alteration of information in other part of the form will invalidate the signature. At this point the application is ready to be submitted electronically on the same day as the booking is made. Paper copy is not accepted under any circumstances

For detailed information, please visit Central Booking Office

It is normally the responsibility of the receiving REC Manager to decide whether or not the application is valid and to notify the applicant. Notification should normally be given within 5 working days of receiving the application, or within 2 working days for applications submitted for proportionate review.

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