Whether you are following the HRA Approval or REC-only route, the following steps apply:
The following information describes the ethical review process - depending on your study, this may form part of your overall HRA Approval or may be a stand-alone process for studies which require ethical review only. To help you understand what your study needs, visit the What approvals and decisions do I need? page.
Phase 1 studies in healthy volunteers may be booked through the Central Booking Service (CBS) or direct with your preferred REC, which is recognised to review this type of research. ‘Recognised’ RECs are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of Clinical Trials of Investigational Medicinal Products (CTIMPs), in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004.
If you are submitting your application as part of the combined ways of working pilot, please check our dedicated page, which outlines differences in the booking and submission process.
For HRA Approval applications, you will receive a status update sent by email informing you of the outcome of the validation of the study. Once the application is valid, you will receive the details for the ethical review and an initial assessment letter which will allow you to provide the local information pack to NHS organisations in England and Wales. For studies which do not need HRA Approval but require an ethical review, you will receive the details for the ethical review once the application is valid but you will not need an initial assessment letter.
To ensure your application is 'valid first time' then you are encouraged to read the information contained in our research planning section.
Your study may be eligible for proportionate review. If this is the case then you will be notified when you book your application in through the Central Booking Service.
The Proportionate Review Service (PRS) provides an accelerated, proportionate review of research studies which raise no material ethical issues. Studies are reviewed via email correspondence, teleconference or at a face to face meeting by a sub-committee (comprised of experienced expert and lay members) rather than at a full meeting of a REC.
All other applications are considered at a full Research Ethics Committee (REC) meeting.
Attending a Research Ethics Committee meeting
Unless your applications is being processed under the Proportionate Review Service, you should attend the REC meeting if possible. Find out what you need to do.
After the meeting
You will be notified of the REC’s decision, usually within 10 working days, and will receive one of the following decisions:
- Favourable opinion
- Favourable opinion with additional condition
- Provisional opinion
- Unfavourable opinion
Detailed information on what these decisions mean can be found in the REC Standard Operating Procedures.
The letter may
contain details of any revisions and clarification the REC requires and
sometimes the REC may make some suggestions about your research. If this
is the case, you may be required to submit further clarification, information
or revised documents to the REC which will be reviewed, usually by the REC Chair
or a sub committee of the REC, before confirming a final opinion.
If you receive an unfavourable ethical opinion, this does not necessarily mean that the research can never go ahead. Your letter will provide detailed reasons as to why an unfavourable opinion was issued, and you can submit a revised application to take account of the ethical issues raised and to demonstrate how the points highlighted by the REC have been addressed.
If you have any queries or wish to discuss the content of your letter, you should contact the REC manager or the named person in your decision letter.
There are standard conditions which should be followed after a REC favourable opinion has been issued or for non REC studies after HRA Approval has been issued:
- for CTIMPS – SL-AR1 should be used.
all other studies requiring REC review – SL-AR2 should be used.
- for non REC studies – SL-AR3 should be used.
When will I receive the outcome of the REC review?
A REC is required to give an ethical opinion on an application within 60 calendar days of the receipt of a valid application. If you chose not to attend the first meeting available, the 60 calendar days will start from the cut-off date for the meeting (which is 14 calendar days before the meeting date).
Where the REC considers that further information is required in order to give an opinion, it may make one request in writing for further information. The period of 60 days will be suspended pending receipt of this information.
It is increasingly likely that the REC decision will be communicated to you as part of the overall HRA Approval process.
If your application has received an unfavourable opinion and you can address the reasons given for this by the REC, you should revise your research proposal accordingly. You should submit it to the same REC, if convenient, as a new application. We recommend that you follow this course of action wherever possible. However, it is possible to submit the application to a new REC if you prefer.
If your application has received an unfavourable opinion and you do not feel it is possible to make all of the changes required by the reviewing REC, you can appeal. In this instance you should email the Appeals Manager who will consider the most appropriate way forward.
If your appeal goes ahead, we will arrange for your original application to be reviewed by a different REC. For more information please refer to REC Standard Operating Procedures (SOPS).
If you believe that your application has not been reviewed fairly or you are unhappy about the way that a REC has dealt with you or your application, visit our feedback and raising concerns page.