• Approval of a Data Access Committee that develops and applies criteria for determining whether the interests of specimen and data sources,24 the repository, and the federal government are being met.
  • Participation of a DoD-affiliated monitor trained in and assigned the responsibility of ensuring the appropriate use of repository specimens and data and safeguarding the interests of its sources, the repository, and the federal government. The monitor would also facilitate research by helping outside investigators to identify and gain access to the most appropriate JPC resources for a particular project.
  • Implementation of data-use agreements and material-transfer agreements, as appropriate, to help to protect the identified interests. A data-use agreement (DUA) is, in brief, a contract between a data provider (here, the JPC) and a user (such as a researcher) that explicates how the data may be used, who may have access to them, how they must be stored and secured, and how they must be handled after the authorized research is completed. A material-transfer agreement (MTA) serves the same purpose for such items as biospecimens. DUAs and MTAs were used by AFIP and are widely used by other research biorepositories and by the federal government to inform investigators of their responsibilities and to gain their agreement to abide by a set of requirements.

REFERENCES

AFIP (Armed Forces Institute of Pathology). 2007. Pamphlet 40-24. Technical instructions for the DoD Clinical Laboratory Improvement Program. Washington, DC.

Amin W, Parwani AV, Schmandt L, Mohanty SK, Farhat G, Pople AK, Winters SB, Whelan NB, Schneider AM, Milnes JT, Valdivieso FA, Feldman M, Pass HI, Dhir R, Melamed J, Becich MJ. 2008. National Mesothelioma Virtual Bank: a standard based biospecimen and clinical data resource to enhance translational research. BMC Cancer 8:236.

Asterand. 2008. Assessment of the Department of Defense’s tissue repository located at the Armed Forces of Pathology in Washington DC. Detroit, MI: Asterand, Inc.

Baker personal communication. 2011. Responses to questions posed by the Institute of Medicine Committee on the Review of the Appropriate Use of AFIP’s Tissue Repository Following Its Transfer to the Joint Pathology Center by COL Thomas P. Baker, MD, Interim Director, Joint Pathology Center. September 6, 2011. A copy of this document is available from The National Academies Public Access Records Office.

Baker TP. 2011. The Joint Pathology Center. Presentation before the Committee on the Review of the Appropriate Use of AFIP’s Tissue Repository Following Its Transfer to the Joint Pathology Center, April 21, 2011.

Beskow LM, Namey EE, Cadigan RJ, Brazg T, Crouch J, Henderson GE, Michie M, Nelson DK, Tabor HK, Wilfond BS. 2011. Research participants’ perspectives on genotype-driven research recruitment. Journal of Empirical Research on Human Research Ethics 6(4):3-20.

___________________

24Including privacy interests.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement