IOM Offers Guidance on National Tissue Repository

The Institute of Medicine (IOM) issued its report on the Future Uses of the Department of Defense Joint Pathology Center Biorepository, formerly referred to as the Armed Forces Institute of Pathology (AFIP) Tissue Repository, on October 10, 2012.  The report offers guidance to the Department of Defense (DoD) on how to maintain and manage the millions of tissue samples and related medical information.  At the request of DoD, the IOM report also outlines appropriate uses of the repository’s samples in research, education and consultation.

Prior to the IOM, the first consensus conference on the present status and future use of the repository took place over two days in August 2005.  Weeks prior to the commencement of that conference, the Base Closure and Realignment Commission concurred on an earlier DoD recommendation that “all elements of the Armed Forces Institute of Pathology except the National Medical Museum and the Tissue Repository” be disestablished.  Yet, neither DoD nor the BRAC provided further details for the administration and maintenance of the tissue repository.  The 2005 consensus conference, produced by Auburn Health Strategies, gathered experts representing the fields of medicine, law, ethics, consumers, academia and industry.  The AFIP Tissue Repository Consensus Conference Statement acknowledged the value and use of the AFIP Tissue Repository to the public health and military medicine.  It also urged a move toward more digitization of slides, institution of a scientific review process for obtaining materials from the Repository, continued modernization and sufficient financial support.

In 2010, the IOM convened the Committee on the Review of the Appropriate Use of AFIP’s Tissue Repository Following Its Transfer to the Joint Pathology Center. The 2012 report issued by that Committee observed that the Joint Pathology Center (JPC) “faces major challenges as it transforms into a modern biorepository that provides clinical consultation, education, and research services.”  It cautions that the “operators of such a repository must be circumspect in their expectations and representations” noting the utility and variability of the collection.  It offered several recommendations for JPC for the future use of the Repository, including:

  • JPC, as part of its plan for improving the use of repository materials in research, evaluate the strengths and limitations of the collection to the extent permitted by its resources and current science and technology. The JPC should consider how to enhance the repository’s value given its organizational and budgetary constraints.  A retention policy and dissemination management and marketing strategies should also be formulated.
  • Determine immediately whether it has the statutory ability to recover the costs of providing specimens and data for approved research projects.  If not, JPC should work with DoD leadership to determine the best way to establish this ability.
  • Develop protocols for determining when to retain potentially useful materials and when to dispose of specimens that have no special research or educational value and are past the point of required retention for clinical use. 
  • Adopt a set of best practices for collection, processing and storage of incoming specimens – either by developing its own or using an established set.
  • Evaluate specimens only when they are retrieved for clinical, education or research purposes rather than undertaking a costly, comprehensive assessment of all specimens.
  • DoD Office of the General Counsel should advise JPC of procedures required by law when implementing disposal policies.  Materials in the BRAC Collection, a subset of the Repository collection, should be retained only for as long as stated by the College of American Pathologists, the DoD’s Clinical Laboratory Improvement Program, or Clinical Laboratory Improvement Amendments (CLIA) requirements, whichever is longer.  The Committee found no unique value to this collection that may not be replicated in other facilities.
  • Dissemination of biospecimens by the JPC for educational purposes should be subject to strict compliance with rules and procedures to protect source identity.
  • Develop a policy for evaluating requests for use of repository materials in the medical care of people other than the specimen source.
  • Adopt a policy on the research use of tissues submitted originally for clinical consultation.
  • Consider, when evaluating whether any given specimen should be available for research, the age of the specimen; disease state represented; medical, scientific and historical significance; if proposed use would exhaust research potential; if research could be achieved with less rare specimens or other sources; public and military health needs.
  • Establish criteria for determining whether to deplete a specimen to exhaustion, in close consultation with pathology subspecialty experts.
  • Recommends no priori restrictions on which applicants may apply for access to the Repository’s specimens and data.  A DoD-affiliated monitor responsible for ensuring appropriate use of specimens and data should be assigned along with the implementation of data-use and material-transfer agreements.

This report and its recommendations, prepared at the request of DoD, will be evaluated by the agency.