Summary
Recent advances in high-throughput assays for gene expression (genomics), proteins (proteomics), and metabolites (metabolomics) have engendered a parallel need for well-annotated human biological samples. Samples from both diseased and unaffected normal tissues are often required. Biorepositories consist of a specimen bank linked to a database of information. Assuring chain of custody and annotation of samples with relevant clinical information is required. The value of samples to end users is generally commensurate with the quality and extent of relevant clinical data included with the samples. Procurement of tissues is often done with parallel pre- and/or post-treatment venipuncture to obtain blood and tissue samples from the same subject. Biorepositories must also process, preserve, and distribute samples to end users. Like traditional libraries, biorepositories are meant to be used, and they are most useful when the needs of end users (researchers) are considered in the planning and development process. Ethics review and an awareness of regulatory requirements for storage, transport, and distribution are required. In the USA, Institutional Review Boards are the local regulatory entities that review protocols for banking of human biological tissues. Governmental and professional agencies and organizations provide some guidelines for standard operating procedures. The Food and Drug Administration (FDA), the Centers For Disease Control (CDC), and professional organizations such as the American Association of Tissue Banks (AATB), the American Association of Blood Banks, The International Red Cross, International Society for Biological Repositories (ISBER) and other organizations provide guidelines for biorepositories and banking of human tissues (see Table 1). To date, these guidelines are directed largely toward procurement, banking, and distribution of human tissues for therapeutic uses. In the international setting, the World Health Organization provides ethical guidelines for procurement and operating procedures.
The most commonly available tissues are formalin-fixed paraffin-embedded tissues (FFPET). While FFPET can be used for immunohistochemistry, certain DNA-based assays, and even RNA, frozen tissues are best suited for isolation and characterization of proteins and RNA. Freezers, back-up systems, monitors, and alarm systems and appropriate physical security are needed for long-term storage of frozen tissues. Other storage formats such as blotting onto filter paper for storage at room temperature are more commonly used for blood and can provide important “fingerprinting” for chain of custody, linking a given subject to a tissue sample.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Goodman, K.W. (1996) Ethics, genomics and information retrieval. Comput. Biol. Med. 26: 223–229.
http://biospecimens.cancer.gov/biorepositories/guidelines_full_formatted.asp
Wendler, D. (2006) One-time general consent for research on biological samples. Arch. Int. Med. 166: 1449–1452.
Hansson, M.G., Dillner, J., Bartram, C.R., Carlson, J.A., and Helgesson, G. (2006) Should donors be allowed to give broad consent to future biobank research? Lancet Oncol. 7: 266–269.
AORN Recommended Practices Committee (2006) Recommended practices for surgical tissue banking. AORN J. 83: 435–442; 445–450; 453–456.
Ellenberg, S.S. and George, S.L. (2004) Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Stat. Med. 23: 1503–1505.
van Es, G.A. (1996) Research practice and data management. Neth. J. Med. 48: 38–44.
Bao, W., Schmid, J.E., Goetz, A.K., Ren, H., and Dix, D.J. (2005) A database for tracking toxicogenomic samples and procedures. Reprod. Toxicol. 19: 411–419.
http://epi.grants.cancer.gov/CFR/biospecimen_fresh_tissue.html#safety
Almeida, A., Thiery, J.P., Magdelenat, H., and Radvanyi, F. (2004) Gene experession analysis by real-time reverse transcription polymerase chain reaction: influence of tissue handling. Anal. Biochem. 328: 101–108.
Ketheesan, N., Whiteman, C., Malczewski, A.B., Hirst, R.G., and La Brooy J.T. (2004) Effect of cyropreservation on the immunogenicity of umbilical cord blood cells. Trans. Apheresis Sci. 30: 47–54.
Florell, S.R., Coffin, C.M., Holden, J.A., Zimmermann, J.W., Gerwels, J.W., Summers, B.K., Jones, D.A., and Leachman, S.A. (2001) Preservation of RNA for functional genomic studies: A multidisciplinary tumor bank protocol. Mod. Pathol. 14: 116–128.
Davis, J.C., Shon, J., Wong, D.T., Jaffe, S., and McEvoy, J.A. (2005) DNA-based biological sample tracking method. Cell Cell Presev. Technol. 3: 54–60.
Titford, M.E. and Horenstein, M.G. (2005) Histomorphologic assessment of formalin substitute fixatives for diagnostic surgical pathology. Arch. Path. Lab. Med. 129: 502–506.
Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, and National Institutes of Health, 4th ed., May 1999, available online at http://www.cdc.gov/OD/OHS/biosfty/bmbl4/bmbl4toc.htm.
Nestler, G., Steinert, R., Lippert, H., and Reymond, M.A. (2004) Using human samples in proteiomics-based drug dev elopement: bioethical aspects. Exp. Rev. Proteomics 1: 77–86.
Wylie, J.E. and Mineau, G.P. (2003) Biomedical databases: Protecting privacy and promoting research. Trends Biotechnol. 21: 113–116.
Auray-Blais, C. and Patenaude, J. (2006) A biobank management model applicable to biomedical research. BMC Med. Ethics 7:4.
Eiseman, E., Bloom, G., Brower, J., Clancy, N., and Olmsted, S.S. (2003) Case Studies of Existing Human Tissue Biorepositories, The Rand Corporation. Santa Monica, CA, http://www.rand.org/pubs/authors/e/eiseman_elisa.html.
Gregersen, P.K. and Lundsten, R. (2001) Robotic and Information Systems for large scale Genetic Studies. The North Shore LIJ Biorepository and the New York Cancer Project. Biotechnic and Histochemistry 76: 223–232, see also http://www.biorep.org/Library.
Burnett, L., Barlow-Stewart, K., Proos, A.L., and Aizenberg, H. (2003) The “Gene Trustee”: A universal identification system that ensures privacy and confidentiality for human genetic databases. J. Law Med. 10: 506–513.
Wylie, J.E. and Mineau, G.P. (2003) Biomedical databases: Protecting privacy and promoting research. Trends Biotechnol. 21: 113–116.
Gunn, P.P., Fremont, A.M., Bottrell, M., Shugarman, L.R., Galegher, J., and Bikson, T. (2004) The health insurance portability and accountability act privacy rule – A practical guide for researchers. Med. Care 42: 321–327.
Blobel, B., Nordberg, R., Davis, J.M., and Pharow, P. (2006) Modelling privilege management and access control. Int. J. Med. Informatics 75: 597–623.
Connell, C.A. (2003) ERES compliance and data integrity issues in e-Trials. SoCRASource, February:24–27, available online at http://www.socra.org/html/publications.htm.
International Society for Biological and Environmental Repositories (ISBER) (2005) Best practices for Repositories I: Collection, Storage and Retrieval of Human Biological Materials for Research. Cell Pres Technol. 3: 5–48.
Available by writing AATB Business Office, 1320 Old Chain Bridge Road, Suite 450, McLean VA, 22101.
Atkin, G., Daley, F.M., Bourne, S., Glynne-Jones, R., Northover, J., and Wilson GD. (2006) The effect of surgically induced ischaemia on gene expression in a colorectal cancer xenograft model. Br. J. Cancer 94, 121–127.
Lepor, H. and Kaci, L. (2003) Contemporary evaluation of operative parameters and complications related to open radical retropubic prostatectomy. Urology 62: 702–706.
Gaston, S.M., Soares, M.A., Siddiqui, M.M., Vu, D., Lee, J.M., Goldner, D.L., Brice, M.J., Shih, J.C., Upton, M.P., Perides, G., Baptista, J., Lavin, P.T., Bloch, B.N., Genega, E.M., Rubin, M.A., and Lenkinski, R.E. (2005) Tissue-print and print-phoresis as platform technologies for the molecular analysis of human surgical specimens: Mapping tumor invasion of the prostate capsule. Nat. Med. 11: 95–101.
Latham, G., Magotra, A., and Gaston, S.M. (2006) Cancer biomarker quantification using RNA extracted from tumor tissue print micropeels. Ambion TechNotes 13(2): 25–26 http://www.ambion.com/techlib.
The Association of University Technology Managers http://www.autm.net.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2008 Humana Press, a part of Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Troyer, D. (2008). Biorepository Standards and Protocols for Collecting, Processing, and Storing Human Tissues. In: Liu, B.CS., Ehrlich, J.R. (eds) Tissue Proteomics. Methods in Molecular Biology™, vol 441. Humana Press. https://doi.org/10.1007/978-1-60327-047-2_13
Download citation
DOI: https://doi.org/10.1007/978-1-60327-047-2_13
Publisher Name: Humana Press
Print ISBN: 978-1-58829-679-5
Online ISBN: 978-1-60327-047-2
eBook Packages: Springer Protocols