The following applies to scientific research in the health sector involving human subjects as well as to retrospective studies
The acquisition, use and delivery of health information materials for use in scientific studies shall be in accord with the objective of the study and with the approval granted by the National Bioethics Committee (NBC) or Health Research Ethics Committee (HREC). The handling of personal information in the context of scientific research is subject to the provisions of the Act on the Protection of Privacy as regards the Processing of Personal Data, No. 77/2000.
When a biological sample is collected for preservation in a research biobank, the free, informed consent of the person giving the biological sample shall be sought. This consent shall be given freely and in writing after the donor of a biological sample has been informed of the objective of the sample collection, the benefits, risks associated with its collection. A broad consent entails that the biological sample will be permanently stored at a research biobank for use in subsequent research approved by the NBC. In the case of a narrow consent, biological samples as well as personal data shall be destroyed upon copmpletion of the study.
Biological samples shall be acquired for clearly defined and lawful purposes, and shall not to be used for other ends. The board of a biobank shall make agreements with scientists on access to biological samples. Access to biological samples for scientific studies may not, however, be approved until the research protocol has been approved by the NBC or a HREC.
When access is granted to biological samples for scientific studies, these shall be provided without personal identification. In exceptional circumstances it is permissible, with the approval of the DPA, to provide biological samples with personal identification. The key between samples and personal identification shall be preserved in keeping with the rules of the DPA.
The Board of a Biobank may, with the approval of the NBC or a HREC, authorize the use of biological samples for other purposes than those for which the samples were originally collected, provided that exigent interests are at stake, and that the potential benefit outweighs any potential inconvenience to the donor of a biological sample or other parties.