Applications to conduct clinical trials involving gene therapy must be submitted to the Gene Therapy Advisory Committee (GTAC) for approval. GTAC was established in 1993, following the recommendations of the 1992 Clothier Committee Report on the Ethics of Gene Therapy.
From 1st June 2011 oeprational responsibilites for Gene Therapy Advisory Committee (GTAC) has been transfered to NRES. For further information please contact:
Room 12, 4th Floor West
Fulham Palace Road
London. W6 8RF
020 3 311 0103 or firstname.lastname@example.org
Developments in gene therapy research and their implications;
- Researchers should be aware that all gene therapy is considered as research, and recruitment of patients into research studies takes place under strict rules set out by GTAC.
- NRES approval must be obtained before somatic cell gene therapy (ie on any cell other than the sperm or egg cells) or gene transfer research, is carried out.
- Applications to conduct clinical trials involving gene therapy should be submitted to the NRES. Protocols submitted less than 60 days before the next full committee meeting will be considered at a subsequent meeting.