New European guidelines for the use of stored human biological materials in biomedical research.

The increasing possibilities for using tissue for research and development in genetics and biotechnology have made stored human biological materials more important than ever. Using stored human biological materials raises many legal and ethical questions. On an international level however, the use of these materials has not been regulated in a detailed manner so far. The Council of Europe recently declassified the text of the proposal for an instrument on the use of archived human biological materials in biomedical research for public consultation. The purpose of this paper is to comment on this document regarding its primary goal, which is to protect the rights and fundamental freedoms of the individual whose biological materials could be included in a research project. The guidelines offer good basic protection for sources of identifiable human biological materials but, surprisingly, offer no protection to sources of anonymous or anonymised materials.