Applying to a Research Ethics Committee

Research planning

Before you begin an application for your research there are a number of planning and preparation activities you need to complete. Our research planning section will help you with these activities.

If you’re making a CTIMP application, please check our dedicated page for the booking and submission process.

Validation 

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', you are encouraged to read the information in our research planning section.

You can also take a look at our checklist of the things that most frequently cause an application to be considered invalid.

Proportionate Review 

Your study may be eligible for Proportionate Review. If this is the case then you will be notified when you book in your application through the Online Booking Service. We strongly recommend that you use the Proportionate Review toolkit to consider whether your study might be suitable for Proportionate Review or whether it requires a full REC review before submitting. The toolkit must be used in Microsoft PowerPoint slide show view – you can then answer the questions by selecting the appropriate box.​ You can also access a text version of the toolkit.

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 of REC members rather than at a full meeting of a REC.

All other applications are considered at a full Research Ethics Committee (REC) meeting. 

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 conditions
• provisional opinion
• unfavourable opinion (only for non-CTIMP applications)

Detailed information on what these decisions mean can be found in the REC Standard Operating Procedures.

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. 

Standard conditions

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 – the CTIMP Standard Conditions should be used
• for all other studies requiring REC review - the Non-CTIMP Standard Conditions should be used
• for non REC studies – SL-AR3 should be used 
• for Research Tissue Banks - the RTB Conditions of Approval should be used
• for Research Databases – the RD Conditions of Approvals should be used
• for programmes of research – the programmes of research standard conditions of approval should be used

When will I receive the outcome of the REC review?

If the REC and/or MHRA send a request for further information, the sponsor has up to 60 calendar days to provide a response. The sponsor can respond at any point within this time frame. An outcome will be given within 10 calendar days once the sponsor has responded to the request.

If sponsors need longer than 60 days to respond, they can ask for an extension. Sponsors can do this by contacting the MHRA (for CTIMP studies) at clintrialhelpline@mhra.gov.uk or, if the points raised only relate to the REC review, by contacting the REC directly. In their request, the sponsor will need to explain why they need an extension and when they expect to respond. If an extension is agreed, the REC and MHRA will make each other aware of this.

If the response is incomplete, or does not address the matters raised, the REC or MHRA will contact the sponsor and ask them to submit a complete response to the request for further information.

The 10 day timeframe will not begin until a complete response to all issues raised by both the REC and MHRA (as relevant) is received. Once a complete response is received, the MHRA and REC will review the response and provide the outcome as quickly as possible.

There are 3 possible outcomes from REC reviewing a response to a request for further information:

• favourable opinion
• favourable opinion subject to conditions
• unfavourable opinion

Independent expert advice

For some applications, the REC or MHRA may need independent expert advice from a specialist group or committee.

For information on when independent expert advice may be needed, read the MHRA's guidance. Their guidance also explains what a sponsor should do if they suspect their application may need independent expert advice.

When independent expert advice is needed, it will be sought during the initial review of an application and/or after receiving a response to a request for further information. The timeframes for the approval process may be extended to allow for the advice to be requested and received.

If independent expert advice is sought:

• during the initial review stage for your application, the 30 day timeframe may be extended by up to an additional 90 calendar days (bringing the maximum timeframe to 120 calendar days)
• following a response to a request for further information being received, the 10 day timeframe may be extended by up to an additional 30 calendar days (bringing the maximum timeframe to 40 calendar days)
• following a response to a request for further information being received and an advanced therapy medicinal product (ATMP) is involved in the trial, the 10 day timeframe may be extended by up to an additional 60 calendar days (bringing the maximum time frame to 70 calendar days)

In all cases, we’ll make sure it proceeds as quickly as possible to avoid unnecessary delays in sponsors receiving the outcome.

If the REC or MHRA determine that they need to seek independent expert advice, they'll notify the sponsor, ask the sponsor for any additional information needed, and let the sponsor know when they can expect to receive the outcome.

Resolving issues 

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. 

Appeals

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). 

Raising concerns

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.

Approval lapses

All CTIMPs submitted from 28 April 2026 are expected to recruit their first participant in the UK within 2 years of the trial being approved (meaning when the trial received both authorisation from the MHRA and a favourable opinion from the Research Ethics Committee).

This also applies to trials involving an advanced therapy medicinal product (ATMP).

If a trial recruits no participants within 2 years, the approval for the trial will lapse. In this scenario, the sponsor will have to end the trial and submit notification in writing by the date that the approval lapsed. Continuing to run a CTIMP after the approval has lapsed is an offence under the amended clinical trials regulations.

If a sponsor has submitted a CTIMP application before 28 April 2026, this expectation does not apply. This means the approval will not lapse if the trial does not recruit its first participant within 2 years.

Confirming the first UK participant has been recruited

Sponsors should confirm the date that the first UK participant in a trial is recruited. Sponsors can do this by using the Modification Tool to submit a modification of an important detail which confirms the first recruitment has occurred.

Extending the 2 year timeframe

We understand that in some situations, recruitment for trials may be challenging. If a sponsor suspects that their trial will not recruit the first participant within the first 2 years, they may be able to extend this time period. They can request an extension in 2 ways:

• as part of the clinical trial application (if this extension is agreed, it will be communicated in the outcome of the application)
• if the trial has already been submitted, the sponsor can request an extension by emailing the MHRA at clintrialhelpline@mhra.gov.uk (once it has been considered and a decision is made, the sponsor will be notified within 30 calendar days. To make sure the request is processed in time the sponsor should submit it at least 31 calendar days before the end of the 2 year period)

The request for an extension should include the reason why it’s needed and how long of an extension is being sought. If the MHRA agrees an extension is appropriate and justified, they can extend the timeframe by up to an additional 3 years after the lapse date.

If an extension of an additional 3 years is given, this means the trial would have 5 years from the trial approval date to recruit its first participant.

Further extensions to the recruitment timeframe

If a trial is reaching the end of the extended period and needs a further extension, the sponsor can request it by submitting another written request to the MHRA by emailing clintrialhelpline@mhra.gov.uk.

The request should be made at least 31 days before the previously agreed extension period ends. It will then be considered, and a decision will be sent to the sponsor within 30 days. Each further extension that is agreed will be extended by up to 2 additional years starting from the end of the previously agreed extension period.

If the sponsor does not submit an extension request in time, or if an extension is not agreed, the approval for the trial will be considered to have lapsed once the end of the 2 year (or extension) period is reached. At this point, the sponsor will be expected to end the trial.