If your study is led from England and involves the NHS is England, you should now use HRA Approval.
This section provides information about applications for review by RECs within the UK Health Departments’ Research Ethics Service and it is important to make sure you understand the information on this page before booking and submitting your application.
NHS RECs review research taking place in or through the NHS, and other health and social care research as required by law or policy. This includes the Gene Therapy Advisory Committee.
However, if you are applying to one of the following types of Research Ethics Committee, you will need to click on the relevant link:
NHS RECs and Social Care REC
Apart from limited specific situations (see Governance Arrangements for Research Ethics Committees), only one REC needs to review a project for the whole of the UK. Some projects taking place outside the NHS require a specific review of the individual sites (site specific assessment). This review is undertaken by the REC reviewing the study application.
All applications for NHS and Social Care REC review are prepared using the Integrated Research Application System (IRAS). Guidance on completing the form and supporting documentation is available within IRAS. All applications must be accompanied by the research protocol and relevant documents, in accordance with the applicant’s checklist (which must also be submitted). Application forms must be electronically authorised in IRAS. Additionally, forms and supporting documents are electronically submitted from IRAS. Note that incomplete applications cannot be validated and therefore cannot be reviewed by the REC.
NHS RECs usually review applications in full REC meetings. However, projects that meet certain criteria deemed not to raise material ethical issues may not need to go to a full committee. This proportionate review service which is for studies that present minimal risk or burden for the participant, uses a proportionate review sub-committee to review applications within shorter timeframes on receipt of a valid application.
NHS RECs are geographically located across the UK. You do not have to choose your nearest REC, although that option may be available, depending on the type of research you plan to undertake.
Some studies must be reviewed by a REC that is ‘flagged’ for the type of research which is to take place. For other types of research it may be recommended to use a REC flagged for that type of research.
You must ensure that your application is ready to submit when you telephone to book it in for ethical review. You must electronically submit your application on the same day as you book your application for review. So before booking you must ensure:
- Your application form is complete
- You have all necessary supporting documents to the checklist in IRAS
- The declarations in your application forms have been electronically authorised.
Booking your application
Once you are ready to submit, you must book your application for review.
For NHS RECs, bookings are made through the Central Booking Service (CBS). Phase 1 studies in healthy volunteers may be booked direct with your preferred REC, which is recognised to review this type of research.
Social Care REC applications should be booked directly with the Social Care REC.
Please refer to our detailed guidance for more information.
When you book your application for REC review you will be offered the first available slot for a REC which is suitable for the type of study. You should have your application in front of you as you will be asked some questions to determine which RECs are available to you, dependent on the study type. In addition to selecting a REC that is flagged or recognised for your type of project, there are a number of options available to you.
- You can select geographically – either by choosing a REC in England, Scotland, Wales or Northern Ireland or by Region, e.g. London, West Midlands, North East. Applicants are strongly encouraged to attend meetings in person, although teleconference facilities can be made available on request.
- You can choose a particular REC using the above options – if you have a project of unusual design or that raises particular ethical issues and you have discussed related issues with a particular REC in the past and you would like to submit to the same REC. You should note that if you select a specific REC that is heavily booked up, you may need to wait for more than one month for an available meeting slot.
Once the REC meeting is booked, you will need to enter the details of the name of the REC and the REC reference number at the start of the NHS REC application form in IRAS. Data entry in these fields 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 electronically submit your application and supporting documents to the REC on the same day as making the booking.