[Skip to content]

National Research Ethics Service
Search our Site
Health Research Authority
National Patient Safety Agency - National Research Ethics Service - facilitating and promoting ethical research
.

Gene therapy and other advanced therapy medicinal products

The Gene Therapy Advisory Committee (GTAC) is the UK national Research Ethics Committee for clinical trials of gene therapy, other advanced therapy medicinal products and certain other types of research.
GTAC is part of the National Research Ethics Service and has adopted the NRES SOPs.
 
Applications for ethical review of any clinical trial of a gene therapy medicinal product must be made to GTAC under Regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004, rather than to another recognised REC.

 
In addition to its legal responsibility for trials of gene therapy medicinal products, GTAC is the national flagged REC for the following types of research:

Definition of 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.'

  • Trials of other Advanced Therapy Medicinal Products (ATMPs), i.e. somatic cell therapy and tissue engineered products
  • Trials of stem cell therapy  involving cells derived from stem cell lines
  • Trials of vaccines involving recombinant vectors or vectors with potentially immuno-regulatory mediator molecules
  • First in human trials of vaccine vectors (or variants of vectors in use) or of engineered antigen molecules
  • Other non-CTIMP gene therapy research (e.g. non-interventional trials).

Research studies involving well-established adult stem cell therapies (for example, bone marrow transplantation) or types of vaccine may be reviewed by any appropriate REC.

For advice on whether a particular study is suitable for review by GTAC, please contact the GTAC Secretariat.

All applications to GTAC should be prepared using IRAS in the same way as for any other application.