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 Research Ethics Committee (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 are defined in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC) as:
…[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
Our 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.
We believe these changes have improved the service offered to researchers. As well as providing an opportunity for ethical review across a wider geographical area, we now offer at least 30 meeting dates per year, which has improved timelines for ethical review.
The new processes mean the review of applications now follow RES Standard Operating Procedures, with clear roles for the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committees (RECs), and that any concerns will be addressed through the Memorandum of Understanding between the Health Research Authority (HRA), and MHRA.
Historically GTAC would send applications for external peer review. Now, as with all other RECs, the responsibility for providing peer review rests with the sponsor.
We seek to work in partnership with other organisations to determine whether it is possible to develop some agreed standards. For more information, see the RES 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.
Initial contact should be made via firstname.lastname@example.org.
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.