A UK Stem Cell Bank, funded by the Medical Research Council and the Biotechnology and Biological Sciences Research Council, is being set up at the National Institute of Biological Standards and Control. The aim of the Bank is to provide ethically sourced, quality controlled adult, fetal and embryonic stem cell lines for research and for the development of therapies by the national and international research community. It will be a condition of licensing by the Human Fertilisation and Embryology Authority that all embryonic stem cell lines created in the UK are deposited in the Stem Cell Bank.

The Banks Steering Committee has published, for consultation, a draft Code of Practice for the operation of the Stem Cell Bank. As well as basic operational features such as the management and governance of the Bank, its premises and equipment, personnel and their training, the Code also covers in detail the procedures to be followed for acquisition of new cell lines and the provision of cell lines to researchers and other third parties.

Cell lines offered to the Bank must be screened and validated with respect to their quality (viability, sterility, genetic stability etc), their microbiological safety, their certification as research- or clinical-grade lines, and the medical history of the donor(s). Cell lines will be coded so that they are traceable back to their original donors and to any recipients, but the donors and recipients identities will be kept confidential. All donors must have provided informed consent, and have been given an opportunity to opt to receive feedback of any information about their health status that arises from tests on the stem cells. The draft Code notes that some aspects of these criteria may need to be revised in the light of the forthcoming EU Human Tissue Directive.

Arrangements for provision of stem cell lines to other researchers cover aspects such as approval of the specific research project by the Banks Steering Committee, agreements on rights of exploitation and ownership of intellectual property, negotiation of Materials Use Licences, and audit of research establishments to ensure that they are complying with the regulations and permissions.

Comments on the draft Code of Practice are invited by 31 October 2003. An companion Code of Practice for the Use of Human Stem Cells will also be published for consultation shortly.
comments powered by Disqus