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QJM Advance Access published online on January 17, 2005
QJM, doi:10.1093/qjmed/hci013
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QJM © Association of Physicians 2005; all rights reserved.

Review

Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust

K.B. Bamford 1*, S. Wood 2, and R.J. Shaw 3

1 Department of Infectious Diseases and Microbiology, Imperial College, and Division of Microbiology, Hammersmith Hospitals NHS Trust, London, UK
2 Universal Safety Consultants Ltd, London, UK
3 Medical Director's Office, Hammersmith Hospital, London, UK

* To whom correspondence should be addressed.
K.B. Bamford, E-mail: k.bamford{at}imperial.ac.uk


  Abstract

Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.


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