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MRC launches online stem cell regulation

21 December 2009
Appeared in BioNews 539

The UK's Department of Health (DH) has made public a new website to help stem cell researchers in adhering to statutory, regulatory and best practice requirements. The UK Stem Cell Tool Kit, (accessible at their website), provides an online questionnaire covering the source of the stem cells to be used, whether genetic modification of the cells will occur and the extent of human contact with the materials generated. Answering these questions - which can be completed either in a conventional list or by using an interactive, animated flowchart - produces a summary table, or diagram, of the relevant hurdles for the research project.

Distinguishing between statutory and regulatory requirements, as well as best practice standards, the generated 'route-map' provides a colour coded guide to the steps a research group must take in completing their research. While the 'map view' provides an at-a-glance guide, a more detailed 'project view' provides explanations for each of the steps and explains the basis in law, or otherwise, for each of the stages.

The toolkit, is restricted to coverage of research involving human stem cell usage for research and clinical applications and does not cover stem cells drawn from other animals. It replaces the Interim UK Regulatory Route Map for Stem Cell Research & Manufacture which was published in March of this year and is the product of collaboration between the Department of Health, Medical Research Council and all of the relevant regulatory bodies. In a press release accompanying the launch, Professor Brendon Noble of the Medical Research Council (MRC) Centre for Regenerative Medicine in Edinburgh, said 'This will be an important tool in therapy development planning. It will also act as a focus for discussion over key issues and roadblocks to the development of cell based therapies.'

The tool is intended to clarify the legal and extra-legal frameworks so as to make it simpler for scientists to appreciate and plan the various requirements into their research projects at an early stage. It is freely and openly accessible without registration. Nonetheless the tool's instructions note that it is only intended to provide rough guidance and that the correct regulatory route for any course of research must still be authoritatively ascertained through liaison with the relevant regulatory authorities.

SOURCES & REFERENCES
UK Stem Cell Toolkit
Department of Health |  15 December 2009
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