Biobank Responsibility Changed
Oslo - In order to make the development of biobanks easier the Norwegian government has recently given its subordinate administrative agency and competence centre, the Norwegian Directorate for Health and Social Affairs, the responsibility for the handling of biobank applications. Specific regulations of the handling of genetic samples are laid down in the Act on Biobanks from July 2003. The legislation ensures that the collection, storage, processing and destruction of biobank materials are performed in an ethically justifiable manner. Requirements comprise of implicit consent for diagnosis or treatment biobanks and free explicit informed concent for research biobanks.
Exemptions for further use for new research-related purposes may be allowed by the Ministry after ethical approval, if renewed consent would be difficult to obtain. If a consent is withdrawn, biological samples and data derived from them must be destroyed at request, unless it is already part of a scientific work. Biobank materials may not be sold.