Biological specimen

-Automatic translation

Biological specimens (e.g. blood samples, urine samples, or tissue samples) are taken in healthcare facilities with the consent of the donor or legal guardian. The biological specimens are preserved and may be used for service research in the healthcare system or for scientific research in the future, with the permission of the Scientific Ethics Committee and other legal entities.

Information for a donor of biological specimen

Before obtaining a biological specimen for service research, healthcare professionals must draw the donor or legal guardian's attention to the potential use of the biological specimen and the right to request that the sample not be used for that purpose.

According to a regulation on the storage and use of biological specimens in biobanks (Icelandic), the Directorate of Health or the board of the biobank is obliged to provide the donors of the biological specimen information on the following:

• Whether their biological specimen is stored in a biobank and what kind of biological specimen they are,

• For what purpose the biological specimen was taken,

• Who has received or may receive access to the biological specimen,

• On what grounds such access is granted,

• What safety measures are in place for collecting and storing biological specimens?

Withdrawal of consent to have their biological specimen used for scientific research

Individuals who have given informed consent to using biological specimens for scientific research can withdraw their consent at any time. The principal investigator shall be notified thereof.

• The principal investigator, or those who collected biological specimens for the scientific research, must deliver a confirmation of the withdrawal of consent to the donor of the biological specimen and notify the Scientific Ethics Committee and the Data Protection Authority.

• When a donor of a biological specimen has withdrawn their consent, the biological specimen shall be destroyed. However, the results of studies that have already been carried out and are based on the use of biological specimens do not need to be deleted as long as they are non-personally identifiable.

• The prohibition may apply to all biological specimens that have already been taken or may be taken from the individual for healthcare purposes.

• The Directorate of Health maintains a register (Register of Biobanks Opt-Outs) of individuals who have prohibited using biological specimens for scientific research.

• The guardians of biobanks must ensure that the will of individuals who have prohibited using their biological specimens is respected. It is done with the Register of Biobanks Opt-Outs at the Directorate of Health.