key terms, as well as by the changing—and sometimes conflicting—ethical, legal, and regulatory standards.
Characterizing Biorepositories and Their Norms
Different terms are used to describe collections of the type held by the JPC, including tissue repository, biorepository, and biobank. Each term has a variety of meanings and somewhat different ethical, legal, and regulatory implications (Cambon-Thomsen et al., 2007; Tutton, 2010; With et al., 2011; Wolf et al., 2012, Appendix). Consider the term tissue repository, which has been used to describe collections of human biologic specimens of the sort that were accumulated over 150 years by what is now the JPC. The term seems accurate enough in suggesting that the JPC is archiving material of potential value. But by placing emphasis on the biologic material, tissue repository fails to signal the presence of associated data in the JPC collections, such as medical records and pathology reports, or of the digital slide collection. The same could be said of the more modern term biorepository, which suggests a place to hold biologic materials and hints at their use for biomedical research.4 However, many biorepositories also include data on the persons whose specimens are in the repositories, which led in the 1990s to coinage of the term biobank, defined as “organized biological sample collections with associated personal and clinical data” (Cambon-Thomsen et al., 2007). But the latter term and the related biobanking are still not fully settled with clear and definite boundaries, though the use of the term “bank” rather than “repository” implies a place where not merely deposits but also withdrawals are regularly made. Biobanks have various designs and sizes and include national biobanks set up in a number of countries where people voluntarily place genetic samples and allow the ongoing collection of medical, occupational, and other personal data that are necessary for longitudinal study of potential associations between environmental exposures, genetic variants, and health-related outcomes (Austin et al., 2003). Finally, database and genetic database sometimes also encompass both biologic specimens and associated data; this emphasizes their potential for genomic, epigenomic, proteomic, and related molecular studies (Tutton, 2010).
In line with much of the current literature, the present report uses biorepository and repository interchangeably to refer to the organized collections of biological samples with associated personal and clinical data now held by the JPC for consultative, educational, and research purposes. Another complexity for the committee’s analysis stems from the fact that,
4For instance, the International Society for Biological and Environmental Repositories (ISBER) defines a biorepository as “an entity that receives, stores, processes and/or disseminates specimens as needed” (ISBER, 2008).