Best Practices for Establishing a Biobank
A biobank may be defined as the long-term storage of biological samples for research or clinical purposes. In addition to storage facilities, a biobank may comprise a complete organization with biological samples, data, personnel, policies, and procedures for handling specimens and performing other services, such as the management of the database and the planning of scientific studies. This combination of facilities, policies, and processes may also be called a biological resource center (BRC) (www.iarc.fr). Research using specimens from biobanks is regulated by European Union (EU) recommendations (Recommendations on Research on Human Biological Materials. The draft recommendation on research on human biological materials was approved by CDBI at its plenary meeting on 20 October 2005) and by voluntary best practices from the U.S. National Cancer Institute (NCI) (http://biospecimens.cancer.gov) and other organizations. Best practices for the management of research biobanks vary according to the institution and differing international regulations and standards. However, there are many areas of agreement that have resulted in best practices that should be followed in order to establish a biobank for the custodianship of high-quality specimens and data.
Key wordsBiobank Biological resource center Specimen Liquid nitrogen Biological sample Cryovials Bar code
- 1.Eiseman E, Haga SB, editors. (1999) Handbook of human tissue sources: A national resource of human tissue samples. Santa Monica, CA: RAND Corporation.Google Scholar
- 2.U.S. Department of Health and Human Services National Institutes of Health National Cancer Institute. First-Generation Guidelines for NCI-Supported Biorepositories. 2006. Available from: http://biospecimens.cancer.gov/bestpractices.
- 3.Campbell JD, Skubitz APN, Somiari SB, Sexton KC, Pugh RS (2008) International Society for Biological and Environmental Repositories (ISBER). (2008) Best practices for repositories I: Collection, storage, and retrieval of human biological materials for research. Cell Preserv Technol 3, 5–48.CrossRefGoogle Scholar
- 7.International Air Transport Association (IATA). Infectious substances and diagnostic specimens shipping guidelines 2006. 7th ed. Available from: http://www.iatabooks.com.
- 8.International Organization for Standardization. Available from: http://www.iso.ch/iso/en/ISOOnline.frontpage.
- 9.Eiseman E, Bloom G, Brower J. et al., editors. (2003) Case studies of existing human tissue repositories: “Best practices” for a biospecimen resource for the genomic and proteomic era. Santa Monica, CA: RAND Corporation.Google Scholar
- 10.Grizzle WE, Fredenburgh J. (2001) Avoiding biohazards in medical, veterinary, and research laboratories. Biotechn Histochem 76, 183–206.Google Scholar
- 11.Occupational Safety and Health Administration (OSHA) Standards for Hazardous and Toxic Substances. Available from: http://www.osha.gov/SLTC/hazardoustoxicsubstances/standards.html.
- 12.Information about the Helsinki Declaration of 1964. Available from: http://www.cirp.org/library/ethics/helsinki/.
- 17.Medical Research Council (2001) Human tissue and biological samples for use in research, operational and ethical guidelines.Google Scholar
- 18.Medical Research Council (1999) Human tissue and biological samples for use in research. Report of the Medical Research Council Working Group to develop operational and ethical guidelines. London: Medical Research Council.Google Scholar
- 19.Protocol EPIC Steering Committee. Lyon, October, 2003.Google Scholar
- 20.CARTaGENE Project. Available from: http://www.cartagene.qc.ca/index2.cfm?lang=1.
- 22.Directive 95/46/EC. The European Union Data Protection (Official Journal L 281, 23/11/1995, pp 31–50).Google Scholar
- 23.Eurobiobank. Available from: http://www.eurobiobank.eu.
- 24.The Public Population Project in Genomics (P3G). Available from: http://www.p3gconsortium.org.
- 25.SWEGENE. The Postgenomic Research and Technology Programme in South Western Sweden. Available from: http://www.swegene.org/bioetik.
- 26.Cancer Control using Population Based Registries and Biobanks (CCPRB). Available from: http://www.cancerbiobank.org.
- 27.Andersson K, Bray F, Arbyn B. et al., (2010). The interface of population-based cancer and biobanks in etiological and clinical research – current and future perspectives. Acta Oncologica; Early online, 1–8.Google Scholar