(such as newborn blood spots, as in Bearder v. State of Minnesota14) further indicate growing concern over research use without consent. A 2011 Advance Notice of Proposed Rulemaking from HHS invited comment on possible changes in the regulations governing human-subjects research, including a proposed change that would seek at least general consent from individuals at the time that they receive clinical care, asking permission for future research use of specimens and data (HHS, 2011).

Against that backdrop, the committee believes that it is important to consider which approaches for using archived clinical data and specimens in research and which approaches for accessioning new data and specimens accomplish the goals of protecting and respecting source individuals, meeting public expectations, and supporting the efficient functioning of the repository. It offers guidance based on both current (middle of 2012) and emerging legal, regulatory, and ethical standards.

The committee recommends that the JPC adopt a policy regarding research use of tissues originally submitted for clinical consultation that places transparency and respect for source individuals and populations at its core. The procedures adopted should remain flexible enough to adapt to the changing legal, regulatory, and ethics landscape. The policy should include the elements listed below:

•  Establishment of a Data Access Committee (DAC) that would examine requests to use repository materials (both specimens and data) and that would operate in addition to the Research Review Committee and IRB that the JPC already uses.15 It would be composed of persons in and outside the JPC who have expertise in research ethics, military research, and research on biospecimens. The DAC’s responsibilities should comprise

— evaluating whether proposed research meets the JPC’s goals for the use of its materials.

— determining whether the researcher’s credentials and specimen- and data-handling protocols satisfy the JPC, DoD, and current legal and regulatory requirements.

— reviewing and providing guidance on the proper management of any ethical issues raised by the proposed research.

— ensuring that data use and material transfer agreements made with researchers protect the privacy of source individuals and

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14A10-101 (Minnesota Supreme Court, November 16, 2011).

15The most current repository protocol regarding review of research proposals available at the time of this report was contained in AFIP Regulation 70-1, AFIP Research Program, dated June 7, 2005. The protocol called for review of proposals by a research committee and an IRB and specified the composition and function of these bodies. The committee understands that this regulation is being followed by the JPC.



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