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) as follows:
“…[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.”
Arrangements for the Gene Therapy Advisory Committee (GTAC) – implemented in November 2012
The Health Research Authority (HRA) Board, in its capacity as the Appointing Authority for the Gene Therapy Advisory Committee (GTAC), agreed new arrangements for ethics applications to GTAC at its Board meeting on 25 October 2012. The HRA believes that these changes will improve the service offered to researchers. As well as providing an opportunity for ethical review across a wider geographical area, we will now be able to offer at least 30 meeting dates per year, and are confident that this will improve timelines for ethical review. The new processes mean that the review of applications will follow NRES Standard Operating Procedures, with clear roles for the MHRA and RECs, and that any concerns will be addressed through the Memorandum of Understanding between the HRA and MHRA.
You may book applications to: London – West London and GTAC; South Central – Oxford A; North East – York; or Scotland A REC (based in Edinburgh).
Bookings should be made via the Central 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 five days of receipt and arrangements subsequently made for you to attend the REC meeting.
Historically GTAC would send applications for external peer review. In future, as with all other NRES RECs, the responsibility for providing peer review will rest with the sponsor. The HRA will seek to work in partnership with other organisations to determine whether it is possible to develop some agreed standards. For more information, see the NRES document – Science v Ethics.
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. Professor Andrew George, who will transfer to London – West London and GTAC, is available to provide advice to applicants before submission of their applications for ethical review. Initial contact should be made via firstname.lastname@example.org and the email marked for the attention of Andrew George.
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.