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Offering ‘Wide Access’ to Joint Pathology Center Will Benefit Research, IoM Says

By U.S. Medicine

By Sandra Basu

Samples being filed at the Joint Pathology Center.

WASHINGTON – An expert group is recommending that the Joint Pathology Center permit “wide access” to the world-renowned tissue repository.

The JPC officially opened last year to serve as the federal government’s pathology reference center. Supporting the Military Health Service, DoD and other federal agencies, the JPC holds the largest collection of human pathology specimens in the world, with a tissue repository of 31 million paraffin-embedded tissue blocks, 55 million pathology glass slides and 500,000 to 700,000 wet-tissue samples and more.

From this repository, researchers in recent years studied lung tissues of troops dating as far back as 1918 in order to fully reconstruct the WWI-era influenza virus that killed more than 40 million people worldwide.

Historically, the repository was open to nongovernmental researchers. With the transfer of the repository from the now defunct Armed Forces Institute of Pathology (AFIP) to the new JPC, however, DoD asked the IoM to examine whether access of repository materials should be limited to the federal government, given the defined mission and vision of the JPC, or opened to a larger pool of researchers.

“Permitting wide access to the JPC repository materials promotes the public good through the advancement of medical and scientific knowledge,” the IoM committee responded in a recent report. “It also benefits the DoD by fostering the development of information on the determinants of disease and good health in servicemembers and veterans.”

The committee recommended “that there be no a priori restrictions on which applicants may apply for access to the repository’s specimens and data,” the report stated.

JPC Challenges

Even as the IoM committee recommended that the JPC permit wide access to its materials, it also pointed out “major challenges” the JPC faces as it “transforms into a modern biorepository.” Many of these challenges have to do with assessing the usefulness of the collection, as well as developing retention and maintenance protocols for biospecimens.

“Experience with other biorepositories that, like the JPC, are composed of samples collected in the absence of a purposefully designed protocol indicates that their value may be severely limited by the state of specimens and their associated documentation,” states the report. “Variations in the preanalytic handling of specimens, in specimen preparation and fixation, in postfixation handling and storage, and in accompanying documentation greatly affect their suitability for some forms of analysis.”

The report points to issues such as how the amount of data associated with any given specimen depends on when it was sent to the repository. Another issue is that JPC lacks documentation of any consent forms that may have been signed by patients or research participants for data or specimens that were submitted to the repository.

“Such consents may have been obtained for the clinical procedures used to excise the specimens at the facilities where the individuals received medical care, but it is highly unlikely that they included notification that the specimens could be sent to a remote repository or later used for education or research purposes. Consents for research use may have been obtained for some materials gathered for the war or cohort registries, but the JPC has no documentation on these,” the committee wrote.

Some of the IoM recommendations included:

• The JPC should “evaluate the strengths and limitations of the collection to the extent permitted by its resources and current science and technology, consider how to enhance the repository’s value given the JPC’s organizational and budgetary constraints, and formulate its retention policy and dissemination management and marketing strategies accordingly.”

• Given that JPC wants to make repository materials available on a cost-neutral basis, it should “immediately determine whether it has the statutory ability to recover the costs of providing specimens and data for approved research projects. If it does not, the JPC should work with DoD leadership to determine the best way to establish such an ability.”

• JPC should develop protocols for determining when to keep 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.

• Dissemination of biospecimens by the JPC for educational purposes should be subject to strict compliance with rules and procedures to protect source identity.

• JPC should 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.”

• JPC should adopt a set of best practices for the collection, processing and storage of all incoming specimens, either by developing its own standards or by using one developed by another entity — for example, NCI’s Best Practices for Biospecimen Resources (NCI, 2011).

In response to the report, a JPC spokesperson told U.S. Medicine the center “will carefully consider the recommendations of the IoM during the next year” as officials develop the plan for use of the tissue repository.

“No final decisions have been made regarding the use of the material in the tissue repository,” the spokesperson said in a written statement.

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