The biobanks that fall under the regulation of the Biobanks Act are
established either by a decision of those responsible for the administration of
the biobank, for instance a health care provider, or by a research institute or
a medical company that has received samples from a health care provider.
In connection with the formal establishment, the biobank representative must
determine the purposes for which the biobank will be used. In addition to
medical treatment and other medical purposes tied to the activities of a health
care provider, a biobank may be used for certain specified purposes only, such
as quality assessment and development, education, research, and clinical trials.
Any decision to establish a biobank must be reported by the biobank
representative to the National Board of Health and Welfare. The report should
contain information about the purposes of the biobank, where it is located, who
is responsible for it, and its expected size. Any changes in these conditions
made at a later date must be reported to the National Board of Health and
Welfare.
Biobanks established before the Biobanks Act was in force, that is, before
January 1, 2003, can still be used, given that they are reported to the National
Board of Health and Welfare before January 1, 2005.
It is important to note that the regulations of the Biobanks Act are in force
regarding the use of samples from these biobanks.
All content is © 2003 The National Biobank Program
Feedback | Privacy policy