considered. Some specimens in the war and cohort registries may have been provided under consents that included research use, but the JPC has no documentation of such consents (Baker personal communication, 2011).

Given the changing legal, regulatory, and ethics landscape, this guidance should be reviewed in light of further developments before implementation.19

Use of Consultation Materials from Federal Facilities and Civilian Providers

The Tissue Repository currently contains consult material from both federal facilities as well as that submitted for consultation by civilian providers. Can tissue within the repository from civilian providers be utilized in the same manner as that from federal facilities?

Access by researchers to human materials that entered the JPC repository from federal facilities and from civilian providers20 is generally governed by the same legal requirements and ethical standards. The JPC has an ethical obligation to ensure all materials (as well as data) in its repository are utilized in a manner that respects the privacy of the specimen sources, prevents misuse by researchers who obtain access to them, and protects the security and other interests of the government. Additional protections regarding research on human subjects, especially requirements regarding informed consent, do apply to U.S. military service members,21 and these impose additional review and procedural responsibilities on the JPC.

As noted above, materials contained in some of the war and cohort registries may be subject to additional or different handling requirements that were part of the agreement made by the repository to serve as custodian. The JPC will need to conform to such requirements when making policies for the materials.

Scientific Considerations

Current and Emerging Technologies

What existing or emerging technologies (either as an intrinsic function or through partnership) should be considered in developing a plan for utiliza-

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19The Advance Notice of Proposed Rulemaking issued by HHS in 2011, for example, may lead to changes in the Common Rule that could affect the recommendations offered here.

20The providers are the physicians who and medical facilities that submitted materials for consultation or educational purposes, not the persons from whom the samples were derived. When the provider is a medical professional, this person is also a contributor as defined above.

21These are spelled out in DoD Instruction 3216.02 (November 8, 2011), Protection of Human Subjects and Adherence to Ethical Standards in DoDSupported Research.



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