More on information and consent.

The Biobanks Act stipulates that biological samples may not be collected and stored in a biobank unless the sample provider is informed about why, and about the objectives for which the biobank may be used, and then consents.

In practice, it should be sufficient that the sample provider is presented with fairly basic information on the nature of a biobank and the regulations it falls under, and thereafter consents to, or refuses, storage and use of his or her biological material for certain generally described objectives, for instance medical treatment and/or research. Rules governing practices within the health-care system are produced by county councils and other responsible authorities within the health-care system.

Consent can be revoked wholly or partially at any time. If the revocation refers to all use, the sample shall be destroyed or all identification labels removed. In this respect the regulatory framework differs from what normally applies to personal data under different data file statutes in the area of medicine, where an individual subject normally has no right to request his or her removal from such files.

For certain categories special regulations regarding information and consent apply.

Regarding minors: Tissue samples may not be collected and stored in a biobank unless the guardian of the minor is informed about the objectives for which the biobank may be used and thereafter consents. If the minor has reached such an age and maturity that he or she may make an informed decision independently, then what applies for adults also applies for the minor.

Regarding foetuses: Biological samples may be collected and stored in a biobank only if the woman who is/was pregnant with the foetus consents. If the woman is deceased, then consent must be obtained from her next of kin.

Regarding the deceased: Here the Transplant Act and the Autopsy Act apply, which basically stipulate that consent must be obtained from the sample provider and the next of kin, respectively.

A difficulty that arises is that who is to be regarded as “next of kin” has not been satisfactorily clarified. The problem of disagreements among close relatives also remains to be solved.

The Biobanks Act does not regulate the possibility to collect samples from people who are unable to give explicit consent, due to unconsciousness, mental illness, etcetera. In the preparatory work, it is presupposed that samples are not to be collected in such circumstances. However, this is problematic since the absense of an opportunity to store samples in biobanks may render difficulties in the analysis and subsequent diagnosis, which in turn may lead to less adequate treatment for the patient.

Since the preparatory work is not legally binding, there is reason to consider storage of these samples after all. The rules of the National Board of Health and Welfare state that samples in such cases may be stored if it is motivated with regard to the individual’s medical treatment.