anonymized to include removing the AFIP accession number since it could eventually be linked to the patient by the recipient. The Associate Chair, Department of Repository Services, can assign a control number to anonymized specimens for release as necessary.

The JPC Contributor’s Manual states that “all pathology consultation records maintained by the JPC are protected by the Privacy Act and by the regulations implementing the Health Insurance Portability and Accountability Act” and that “JPC falls under the DoD Notice of Privacy Practices” (JPC, 2011b). The Notice of Privacy Practices specifies (DoD, 2003b) that

we may disclose your protected health information to researchers when authorized by law, for example, if their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your protected health information.

And, as noted in Chapter 1, the JPC Contributor’s Consultation Request Form (2011a)—which medical professionals use to submit materials to the repository—includes the DoD’s Privacy Act statement.

Regulation 40-16, Health Information Privacy (AFIP, 2005) lays out how compliance with the rules is maintained. It requires yearly staff training in health-information privacy standards and describes the duties of a privacy officer, a HIPAA training officer, and a HIPAA compliance committee.

Concluding Considerations Regarding Consent and Custodianship

Even though the various laws and regulations embody ethical considerations, they do not fully address or resolve all the ethical issues. Controversy over the research use of clinically obtained tissue specimens without informed consent, or with only incidental and cursory general consent, is long-standing. Several problematic cases, referred to early in this chapter, provide some of the background of this controversy.

In 1999, the National Bioethics Advisory Commission (NBAC), appointed by President Clinton to study and make recommendations on a range of bioethics issues, published a report on research using stored human biological material. This report is part of a significant and still-growing literature on ethical research use of stored tissue as it relates to the ethical responsibilities of biorepositories and large-scale collections of tissue, material, and data. The NBAC advised that research on identified samples is indeed human-subjects research under the Common Rule and so “requires consent of the source, unless the criteria for a consent waiver have been satisfied” (NBAC, 1999). The commission recommended (p. 64) that

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