Biorepository Standards and Protocols for Collecting, Processing, and Storing Human Tissues

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.

Title	Media	Publisher
BioBank Central	Website	http://www.biobankcentral.org
Cell and Tissue Banking	Journal	Springer Netherlands
Int’l. Ethical Guidelines for Biomediocal Res Involving Human Subjects	Book and On-line	Council for Int’l Orgs of Medical Sciences, World Health Org, Geneva, Switzerlandhttp://www.cioms.ch/
Collaborating with Commerical Tissue Biorepositories	Website	http://www.usm.maine.edu/bioethics/biobank/index.html