Gene Therapy Advisory Committee (GTAC)

GTAC is the UK national research ethics committee (REC) for gene therapy clinical research according to the Medicines for Human Use (Clinical Trials) Regulations 2004 (http://www.opsi.gov.uk/si/si2004/20041031.htm, see article 14(5)). It is the only UK ethics committee empowered to approve clinical trials of gene therapy products according to the definition given in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC):

L159/88 "… [a] gene therapy medicinal product shall mean 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."

Under the Clinical Trials Regulations, GTAC is required to provide an ethical opinion on applications for use of products that fall within the above definition within 90 days of receipt of a valid application.

GTAC's definition of gene therapy is as follows:

"The deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes."

This includes techniques for delivering synthetic or recombinant nucleic acids into humans:

• genetically modified biological vectors (such as viruses or plasmids)
• genetically modified stem cells
• oncolytic viruses
• nucleic acids associated with delivery vehicles
• naked nucleic acids
• antisense techniques (for example, gene silencing, gene correction or gene modification)
• Genetic vaccines
• DNA or RNA technologies such as RNA interference
• xenotransplantation of animal cells (but not solid organs).
  

This definition is slightly wider than that given in Directive 2003/63/EC. In order to cover this, GTAC is a UKECA recognised REC and wishes to approve clinical trials that use certain gene therapy related products that are not covered under the legal definition (for instance, antisense applications) but that are covered by the above definition. In these instances, GTAC is required to provide an ethical opinion within 60 days of receipt of a valid application.

For questions and to seek advice, please contact the GTAC Secretariat.

GTAC's terms of reference are:

• To consider and advise on the acceptability of proposals for gene therapy research on human subjects, on ethical grounds, taking account of the scientific merits of the proposals and the potential benefits and risks.
• To work with other agencies which have responsibilities in this field, including local research ethics committees, and agencies with statutory responsibilities - the Medicines and Healthcare products Regulatory Agency, the Health and Safety Executive and the Department for Environment Food and Rural Affairs.
• To provide advice to United Kingdom Health Ministers on developments in gene therapy research and their implications.

The 1992 report of the Committee on the Ethics of Gene Therapy (the Clothier Committee) recommended that gene therapy (genetic engineering in humans) should be limited to life threatening diseases or disorders. To oversee and implement this, GTAC was established in 1993. GTAC advises on the ethical acceptability of proposals for gene therapy research on humans taking account of the scientific merits and the potential benefits and risks, and provides advice to UK health Ministers on developments in gene therapy research.

The primary concern of GTAC is whether each research proposal meets accepted ethical criteria for research on human subjects. This includes both therapeutic and non-therapeutic research. 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 conducted on human subjects. GTAC will not, at present, consider proposals for germ line cell (egg or sperm) gene therapy. GTAC considers that gene therapy has not yet developed to the stage where it can be considered as treatment. All gene therapy is research and recruitment of patients into research trials takes place under strict rules set out by GTAC, under principles elaborated by professional bodies and only after review of clinical protocols by GTAC.

As well as its annual reports, GTAC has also published reports examining the use of Adenovirus in human clinical trials and the potential use of In utero gene therapy.

UKCRC Regulatory and Governance Advice Service

The UKCRC have established a Regulatory and Governance Advice Service to provide practical help with the legislative and good practice requirements that govern clinical research in the UK. The Service supports local advice providers, such as NHS R&D and university R&D offices, to provide consistent and authoritative advice to their research communities, and so the first port of call for any researcher with a query should be these local offices. The Advice Service is supported by GTAC in partnership with a number of other regulatory and governance bodies.

Further information on the UKCRC R&G Advice Service can be obtained from the website:
www.ukcrc-rgadvice.org.

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