Participant in a scientific study study may at any time revoke his/her consent to participate in a clinical trial or a general biomedical study involving human subjects. The same applies to consent for the retention of biological samples or health data for use in subsequent studies. Once consent is revoked, research on the relevant participant’s biological samples or health data shall cease and the participants may require that their biological samples or health data to be destroyed. It is not possible, however, to require destruction if the biological sample or health data is/are anonymised, if the biological sample has been subsumed into other material, or if data already comprise part of the findings of a study.
The participants may not in any way suffer retribution for their decision to cease participation.
A donor of a biological sample can at any time withdraw his/her consent, and the biological sample shall then be destroyed. Material that has been produced from a biological sample by performance of a study or the results of studies already carried out shall, however, not be destroyed.
If biological samples have been collected for the purpose of clinical tests or treatment, the consent of the patient may be assumed for the storage of the biological sample in a clinical biobank for use permitted provided that general information on this is provided by a health care professional or health institution. A donor of a biological sample may at any time revoke his/her assumed consent for his/her biological sample to be stored in a clinical biobank, in which case it shall thereafter only be used in the interests of the donor of the biological sample or by his/her specific permission. Request of a donor of a biological sample may apply to all personally-identifiable biological samples which have been taken or may be taken from him/her. Such a request must be complied with. The donor of a biological sample shall inform the Directorate of Health of his/her wishes. The Directorate of Health shall have accessible forms for giving such notice, and shall ensure that these are available at health institutions, and at the premises of self-employed health care professionals.
The Directorate of Health shall maintain an encrypted register of individuals who have prohibited use of biological samples and relating information from clinical tests for scientific studies, and storage of such samples in a research biobank. The register shall be accessible to the responsible parties of biobanks, who shall ensure that wishes of individuals are respected.