Experience of Gene Therapy in the United Kingdom

The UK Committee on the Ethics of Gene Therapy recommended the establishment of a supervisory body with collective expertise, experience, and authority to regulate gene therapy. In November 1993, the supervisory body, known as the Gene Therapy Advisory Committee (GTAC), was established. It interacts with other bodies, including the Medicines Control Agency, local research ethics committees, the Health and Safety Executive, and the Hospital Trust. When proposals for gene therapy are reviewed, there is careful assessment of the scientific merits, the competence of those undertaking the research, and the risks involved. Each proposal is assessed by several independent expert advisors, in specific aspects of the research. The researchers are apprised of the issues raised by the assessors and given the opportunity to modify their proposals. The research team is then given the opportunity to make a brief presentation to the GTAC. The proposals may be approved subject to conditions, deferred until further issues are resolved, or rejected on the basis that the proposal is unethical or the science unsound. Researchers are expected to provide the committee with regular progress reports. This paper discusses the experience of gene regulation in the United Kingdom.