research community about the repository’s collection and potential research uses.

•  Regular review of JPC forms, protocols, and procedures to ensure that they meet evolving legal and regulatory requirements and reflect best practices for biorepository operations and management, as defined by, for example, the National Cancer Institute (NCI, 2011) and the International Society for Biological and Environmental Repositories (ISBER, 2012).

Protocols and procedures regarding research use of materials should be public documents and should be regularly updated on the JPC website.

One way that many modern biorepositories manage the difficult issues involved in the ethical use of their materials is to educate specimen sources on the possible use of their materials in research and to seek their consent for such uses. The JPC has no direct control over the mechanisms used to obtain consent from sources whose specimens are sent to its repository. However, it can—in consultation with legal and ethics experts in and outside the military—develop recommended language to be added to existing consent forms and devise accompanying educational materials (such as brochures) that allow substantive choice regarding the research use of specimens obtained for clinical consultation. The JPC can also suggest that physicians who seek consultations with the JPC use consent forms that include this language and can ask the contributing physician for information about research consent from the source individual as part of the Contributor’s Consultation Request Form and code that information in the JPC database for future use. Several model educational materials (NCI, 2012b) and consent forms (Beskow et al., 2011; Hansson et al., 2006; Hofmann, 2009) could serve as a starting point for developing recommended materials for source individuals to consider.

More broadly, the committee believes that the DoD should consider changing patient education materials and consent requests and forms in the manner outlined above to facilitate future use of pathologic materials in research.

The JPC’s IRB may be able to consider many research-use requests under the provisions for exemption or waivers of consent under the Common Rule and waivers or alterations of the authorization to use protected health information (PHI) under HIPAA regulations. Current exemptions17 from human-subjects regulations include studies that use deidentified data

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17Changes to the Common Rule that would require that clinical materials used in research be obtained from individuals who had been informed of their potential use in research and afforded the opportunity to give (or withhold) permission for such use of their specimens and data were under debate in mid-2012 (Emanuel and Menikoff, 2011; HHS, 2011).



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