If your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).
GTAC is the UK national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004.
Gene therapy medicinal products
Gene therapy medicinal products are defined in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC)…[a] gene therapy medicinal product means a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell.
You may book applications to the following RECs:
- London – West London and GTAC
- South Central – Oxford A
- North East – York
- Scotland A REC (based in Edinburgh).
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 five days of receipt and arrangements subsequently made for you to attend the REC meeting.
Pre-application advice and submission to GTAC
You are no longer required to seek pre-application regulatory advice from GTAC. The MHRA will continue to provide this service to commercial companies, and will consider requests for advice from academic researchers.
Categories of applications to be submitted to GTAC
Members of the research community have requested clarity on the type of application that needs to be submitted to GTAC.
Legally, all gene therapy applications must be submitted to a GTAC that is able to transfer to other designated RECs.
To make it easier for researchers and sponsors to identify other studies needing review, other applications that involve cell therapy and/or that are submitted to the MHRA Clinical Trials Expert Advisory Group must also be submitted to GTAC.
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.