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The term biobanks refers to collections of biological material, for example blood or tissue samples. These samples' generally high quality in Sweden and the fact that samples can often be linked with information on the donor's health and diseases makes them very interesting in medical research.

Swedish regulation

In Sweden there is a Biobanks in Medical Care Act (SFS 2002:297), later complemented with Regulation ("Förordning") (SFS 2002:746) regarding biobanks in areas such as health and medical services. The law applies to the biobanks that consist of tissue samples taken and collected for a specific purpose from patients or other donors within healthcare. Of relevance is also the law on quality and security norms regarding human tissue and cells, not least by demanding that some research projects must have authoritative permission to run a tissue bank.

Personal information on biobank donors in the register or in another form is not considered a part of the biobank itself. This information falls instead under the GDPR as well as other legislation regarding personal information and health-related data in the healthcare area. Note that genomic data now explicitly is considered sensitive and that sharing identifiable genomic data is a form of processing personal data, and as such would fall within the scope of data protection laws.

Beginning 1 January 2004 a new law, SFS 2003:460 - The Act concerning the Ethical Review of Research Involving Humans, regulates all research concerning studies of identifiable human biological material. Conduction of such research requires approval by a research ethics committee. Further, the Swedish National Board of Health and Welfare has published regulations and general advice regarding biobanks, as well as on donation och tillvaratagande av vävnader och celler - SOSFS 2009:30, on användning av vävnader och celler i hälso- och sjukvården och vid klinisk forskning - SOSFS 2009:32, and vävnadsinrättningar i hälso- och sjukvården m.m. - SOSFS 2009:31. The following rulings are still relevant regarding biobanks: the law on transplantation (SFS 1995:831) and the law on autopsies (SFS 1995:832). The Biobanks Act will be revised, see Översyn av lagen (2002:297) om biobanker i hälso- och sjukvården m.m. Dir. 2008:71.

European Documents

Within Europe there are also other documents, besides the 1997 European Convention on Human Rights and Biomedicine. The sharing and use of samples is governed by the Directive 2004/23/ECof the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. The Council of Europe's Committee of Ministers' Recommendation on research on biological materials of human origin, and the guidelines by The European Group on Ethics in Science and New Technologies, published 21 July 1998 under the designation Ethical Aspects of Human Tissue Banking (note that some of these documents concern particular kinds of tissue banks). The so called Article 29 Working Party in 2004 presented a Working document on Genetic Data. The European Nutrigenomics Organisation (NuGO) has issued some Bioethics Guidelines on Human Studies and the European Science Foundation has a Policy Briefing on Population Surveys and Biobanking.

International standards

Definitions regarding biobank issues have been developed by ICH: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Most recent is the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks by the World Medical Association. Further we have the Recommendation on Human Biobanks and Genetic Research Databases by the OECD. The Universal Declaration on Bioethics and Human Rights address aspects of biobanking in some of its articles (i.e. no 6, 15, 21, 24), as does the Universal declaration on the human genome and human rights. In 2003, the International Bioethics Committee (UNESCO) effected an International Declaration on Human Genetic Data. WHO has issued an Guideline for obtaining informed consent for the procurement and use of human tissues, cells and fluids in research. International Ethical Guidelines for Health-related Research Involving Humans, by CIOMS, requirements for informed consent in epidemiological studies on biobank samples are discussed. The International Society for Biological and Environmental Repositories (ISBER) has put forth Best Practices for Repositories. Finally, the ethics committee in the Human Genome Organisation has issued a statement on the inspection of and access to DNA banks, as well as a Statement on Human Genomic Databases. A European equivalent to this can be found in the European Society of Human Genetics' Data storage and DNA banking: quality issues, confidentiality, informed consent.

Last updated: 2020-01-14

Rules & guidelines

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