Gene Therapy Advisory Committee 19/7/02. By Deirdre Janson-Smith The Gene Therapy Advisory Committee advises on the ethical acceptability of proposals for gene therapy research on humans.

The Gene Therapy Advisory Committee (GTAC) was established in 1993, following the recommendations of the 1992 Clothier Committee Report on the Ethics of Gene Therapy. All gene therapy is considered as research, and recruitment of patients into research trials takes place under strict rules set out by the GTAC. The primary concern is whether the research proposal meets accepted ethical criteria for research on human subjects.

The GTAC reviews take account of the scientific merits of the research, and its potential benefits and risks. The safety and welfare of patients is of paramount importance. The GTAC considers that gene therapy has not yet developed to the stage where it can be considered as treatment.

GTAC approval must be obtained before somatic cell gene therapy (i.e. on any cell other than the sperm or egg cells) or gene transfer research, is carried out. GTAC will not, at present, consider proposals for germ line cell (egg or sperm) gene therapy.

GTAC reports to UK Health Ministers. It is required to work with other agencies which have shared statutory responsibilities, including local research ethics committees, the Medicines Control Agency, the Health and Safety Executive and the Department of the Environment. It also provides advice to ministers on new developments in gene therapy research and their implications.

The GTAC publishes an annual report, as well as guidelines on submitting protocols to carry out gene therapy and on writing information for patients. Special reports include an examination of the use of adenovirus in human clinical trials, and the potential use of in utero gene therapy.

The GTAC 'Flagging' Project

At present, the United Kingdom leads Europe in gene therapy research – more than 50 per cent of European gene therapy clinical trials take place here. The GTAC has begun a long-term study of patients involved in this therapy. The first of its kind anywhere in the world, the study's aim is to monitor patients' continuing health, to reveal any long term effects of gene therapy treatment.