Gene therapy

Booking Applications

You may book applications to the following RECs:

• London – West London and GTAC
• South Central – Oxford A
• North East – York
• Scotland B REC
• Scotland A (This REC can only review studies requiring ethical approval under the Adults with Incapacity (Scotland) Act 2000)
• London – Brent
• South Central – Berkshire B

Bookings should be made via the Online Booking Service.

Once a booking is accepted, you must electronically submit your application and supporting documentation on the same day. If your application is valid, you will be sent an acknowledgement within 5 days of receipt and arrangements subsequently made for you to attend the REC meeting.

Pre-application advice

Guidance on seeking scientific advice from the MHRA is available on their website.

Applications that involve cell therapy and/or that are submitted to the MHRA Clinical Trials Expert Advisory Group must also be submitted to a REC that is flagged to review these applications.

If a sponsor submits a CTIMP involving gene therapy to a REC not recognised as one that reviews gene therapy applications, this could result in the REC seeking independent expert advice from a REC that is flagged to review these applications.

The role of the MHRA

All gene therapy and cell therapy applications for Clinical Trials Authorisation will be assessed by the MHRA and, where appropriate will now be submitted to the MHRA Clinical Trials Expert Advisory Group for review. 

This review will assure the RECs that appropriate scrutiny of the safety of the application has been carried out. The REC will raise any concerns directly with the MHRA.

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.

Timeline for xenogenic cell therapy applications

If a sponsor submits an application involving xenogenic cell therapy, the same review process will be followed. Both the MHRA and REC will review the application as efficiently as possible, as they would any other application. However, the above timeframes will not apply. This means that outcomes and decisions can be issued at any point after an application is received and validated.