Ethical and legal issues

Ethical issues

The collection was established with a noble purpose: To increase the knowledge of diseases and thus help a large group of underprivileged people. The procedures were in agreement with the ethical standards of that time.

The Danish Council of Ethics and The Danish National Committee on Biomedical Research Ethics made several positive evaluations of the collection. In 2006, they both confirmed that it is ethically justifiable to use the Brain Collection for scientific purposes. (www.etiskraad.dk/sw8821.asp;
www.cvk.im.dk/db/filarkiv/4414/EpostsvarSUM.pdf).
 
In particular, they maintained that it is not ethically correct to contact next of kin for permission to use tissue in the Brain Collection for research projects. However, according to Danish law, all research projects using human tissue need ethical approval from the regional committees on biomedical research ethics. Thus, all research projects using tissue from the Brain Collection must obtain individual ethical approval before initiation.

Translational Neuropsychiatry Unit is responsible for the Brain Collection and thus obliged to ensure optimal scientific use of the brains for the benefit of today’s patients.

Legal issues

The brains were collected, examined, and preserved in agreement with the Danish autopsy rules. Until 1967, the autopsies were practiced in accordance with guidelines from the Ministry of Justice signed 05.12.1913. Actual legal regulations regarding autopsies and human tissue samples were introduced with The Act on Human Tissue Samples etc. in 1967.

In 1990, the act was replaced by the Act on Inspection of Bodies, Autopsy and Transplantation etc. (Act. no. 402 of 13.6.1990).

The provisions on medical autopsy are included in the Health Act section 187.

Pursuant to section 45, subsection 1, cf. section 43 in the Danish Act on Processing of Personal Data (Act no. 429 of 31.5.2000), the Brain Collection has been reported to the Danish Data Protection Agency as a biobank with research purposes (www.datatilsynet.dk/fortegnelse/index.html; File number.: 2005-53-1251). The Brain Collection has permission to store brain tissue and related documentation, including scientific basic data, until 2030.