biorepository might offer two tiers of samples: unscreened—where the recipient would take on the burden of reviewing sample quality—and prequalified samples that pass a JPC lab screen. Presumably the cost of such an audit would be borne by the requesting party. The ability to provide such services would of course be dependent on the availability of the requisite expertise and any organizational and budgetary constraints.

The JPC may also wish to consider means such as the “honest broker” model for providing specimens and data to researchers while protecting the interests of specimen sources in privacy and confidentiality. An honest broker is an individual, organization, or system that serves as neutral intermediary between a provider of materials (a source individual or biorepository, for example) and researchers, collating pertinent specimens and data, replacing identifying information with a code, and releasing only coded information to the researchers (Eiseman et al., 2003; NCI, 2011). The code may be maintained consistently for a specific specimen and study or generated anew for each study (or investigator) to lessen the chance of unsanctioned linkage of records between investigations. Information on subjects may be from one source or several.2

The notion of an honest broker has not only been adopted by some biorepositories (Amin et al., 2008; Boyd et al., 2009; Dhir et al., 2008; Drake et al., 2007) but also has been applied more generally in facilitating the dissemination of materials to life-science researchers (Boyd et al., 2006). It is critical that the organization managing the brokering process define appropriate policies for exchange of information between the repository and the researcher as well as train and certify its personnel on how to execute those policies.3 Honest brokers may either be entities that are outside and independent of a biorepository or be situated within the organization, provided that they are disassociated both from the research projects in which the data and specimens are being employed and from the management of the specimens and data within the repository.

The JPC indicated to the committee that it would like to make repository materials available for research on a cost-neutral basis (Baker, 2011). Because the federal government is in general prohibited from charging nongovernment entities for such services,4the committee recommends that the JPC immediately determine whether it has the statutory ability to recover

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2For example, depending on the study, the Department of Defense, the Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, private insurers, and the Centers for Disease Control and Prevention (through the National Death Index) might have relevant data on a particular subject.

3An example of such practices is described by the University of Pittsburgh Medical Center (UPMC, 2008).

4Federal organizations can recover such costs from other parts of the federal government through interagency transfers (31 U.S.C. § 1535).



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