Regulation and Practice of Human Tissue Research in the UK

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Abstract

The use of human tissue in drug discovery and development is now well accepted, however, its use for experimental purposes is still restricted not only by practical, but also by ethical and legal constraints. The UK government, through its Human Tissue Act 2004, is leading the way in establishing clear ethical and legal guidelines that will both facilitate and regulate the process. It has also set up a Human Tissue Authority, whose task is to establish codes of practice to regulate all aspects of the Act. The Act emphasises donor anonymisation, freely given informed consent, independent ethical review and the licensing of tissue banks. The UK's approach could serve as a model for this important, but still contentious, area of activity worldwide. With the expansion of the availability of human tissue for research, it will undoubtedly eventually become a mandatory part of the regulatory filing for new drugs. This may well first be seen in the testing of cross reactivity of new therapeutic antibodies, for which the FDA has already identified a set of tissues against which they are to be tested. It is timely therefore that the development of frozen tissue microarrays looks to make this a simple and routine operation.

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