Biobanks

The term biobanks refers to collections of biological material, for example blood or tissue samples. Definitions in law may vary between countries and there are various kinds of biobanks, such as DNA banks, blood banks, national or private banks, banks taken for health care purposes or for research, etcetera. Careful reading of guidelines and legislations is therefore required.

European Documents

Within Europe there are also other documents, besides the 1997 European Convention on Human Rights and Biomedicine: The Council of Europe's Committee of Ministers' Recommendation (2006) 4 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 Data Protection 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 Recommendation on Human Biobanks and Genetic Research Databases from 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 and the World Medical Association has presented its Declaration on Ethical Considerations Regarding Health Databases. WHO has issued an Guideline for obtaining informed consent for the procurement and use of human tissues, cells and fluids in research. In International Ethical Guidelines for Epidemiological Studies, 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 Collection, Storage, Retrieval and Distribution of Biological Materials for Research - 2008 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: 2010-01-04