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Summary
In May 1862, the Army Surgeon General, Brigadier General William
Hammond, undertook an initiative to try to learn from the carnage of the
Civil War. He ordered the establishment of the Army Medical Museum as
a research institution that would collect and catalog specimens obtained
from medical and surgical procedures performed by Army physicians and
others and make them available for study (Stone, 2011). The museum ex-
panded and diversified in the years that followed, setting up a Pathology
Department and Instructional Laboratory in 1910 and undertaking an
extensive e ffort to document the medical consequences of combat during
World War I. Several registries--collections of rare or representative bio-
specimens from a particular organ system or representing a specific medi-
cal c
ondition--were established in the early decades of the 20th century,
and new departments were founded as science advanced and the demand
for professional education and expert pathology advice increased. By the
end of the 20th century, the institution, which was renamed the Armed
Forces Insti tute of Pathology (AFIP) in 1949, had accumulated the largest
collection of human pathology specimens in the world and established
itself as a premier consultation, education, and research facility. Perhaps
its best known contribution to science was as the source of some of the
bio specimens used to sequence the genome of the 1918 influenza virus
that killed over 40 million people worldwide and as the home institution
of the lead investigator in the research (Morens et al., 2008; Taubenberger
et al., 2007).
The federal Base Realignment and Closure (BRAC) Commission recom-
mended in 2005 that AFIP be disestablished except for some components,
1
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2 FUTURE USES OF THE DOD JPC BIOREPOSITORY
including the biorepository. The National Defense Authorization Act of
2008 (PL 110-181, § 722) later created the Joint Pathology Center (JPC)
to absorb the AFIP biorepository and continue its duties.
As the transition to the JPC was taking place in 2010, the Department
of Defense (DoD) asked the Institute of Medicine (IOM) to convene an
expert committee to offer advice on several issues related to the operation
of the biorepository and the management of its collection. The questions
posed in its statement of task (Box S-1) were focused on issues related to
the appropriate future use of the specimens in consultation, education, and
research. This report, prepared by the IOM Committee on the Review of
BOX S-1
Questions Posed in the Committee's Statement of Task
· G
iven the defined mission and vision of the Joint Pathology Center, should
access to repository materials be limited to the federal government or open to
a larger pool of potential users? What advantages and disadvantages should
be considered in defining the potential users of the repository in research?
· What are the ethical and legal considerations regarding utilization of the tissue
repository in support of clinical care and education?
· The tissue repository currently contains paraffin embedded tissue, glass slides,
wet (formalin-fixed tissue) and frozen tissue; some of it is not usable for consul-
tation, education, and research given current technology. Should material not
deemed currently usable for consultation, education, and research be stored
indefinitely or should the JPC develop a plan for disposal of unusable or non-
viable specimens and are there any legal considerations with disposal of said
specimens?
· Should the BRAC Collection of materials be maintained indefinitely?
· Can tissue collected for clinical use be used for research (i.e., from patients
not specifically consented for use of tissue in research)?
· What are the ethical considerations regarding use of tissues originally sub
mitted for clinical use for research and can this be accomplished within current
accepted guidelines for clinical research?
· 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 man-
ner as that from federal facilities?
· What considerations should be given to utilization for research of unique, one-
of-a-kind material within the Central Collection of the tissue repository?
· What existing or emerging technologies (either as an intrinsic function or
through partnership) should be considered in developing a plan for utilization
of the tissue repository in research and how would they potentially affect the
mission of the JPC?
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SUMMARY 3
the Appropriate Use of AFIP's Tissue Repository Following Its Transfer to
the Joint Pathology Center, provides responses to those questions.
FRAMEWORK AND ORGANIZATION
The committee organized its response to its statement of task in three
primary chapters addressing the following topics:
· A brief history of the biorepository that is now under the aegis
of the JPC; a description of the current status of its collection, an
explication of the committee's statement of task, the methodologic
considerations that informed the committee's evaluation of the
literature, and summary information on earlier reports addressing
AFIP and JPC operations and on related National Academy of Sci-
ences reports (Chapter 1).
· The means of preserving biospecimens, methods for analyzing and
assessing their research value, and how the details of the specimen's
preservation, storage, and documentation, and the uses to which
they are put may affect prospects for their future use (Chapter 2).
· The ethical, legal, and regulatory considerations underlying the com-
mittee's responses to the questions posed by the DoD with particular
attention to the federal laws and regulations, DoD rules, and AFIP
and JPC regulations regarding research on biospecimens and their
associated data (Chapter 3).
Those chapters contain the detailed literature reviews and analysis of their
relevance to the JPC biorepository that build the foundation for the com-
mittee's findings, conclusions, and recommendations presented in Chapter 4.
Background information on the biorepository's collection is summa-
rized below.
THE STATE OF THE BIOREPOSITORY'S COLLECTION
As of 2011, the JPC tissue repository comprised some 7.4 million ac-
cessions that contained specimens or data from about 3.2 million people
(Baker personal communication, 2011). About 3.2 million of the accessions
are in the Central Collection, which is composed primarily of biologic mate-
rials submitted for consultation by military, other government, and civilian
medical providers. Most of the remaining 4.2 million accessions are from
military medical facilities closed under BRAC Commission proceedings.
They differ from those in the Central Collection in that they include the
complete array of data and specimens collected in the course of the provi-
sion of routine medical care. About two-thirds of the so-called BRAC Col-
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4 FUTURE USES OF THE DOD JPC BIOREPOSITORY
lection cases have both specimens and data; the remaining one-third have
only data (Baker personal communication, 2011). In addition, a series of
war and cohort registries that were created at the direction of Congress or
on the initiative of the Department of Veterans Affairs or DoD comprise
collections of specimens and data from military personnel who shared a
military experience (such as participation in Operation Iraqi Freedom or
time spent as prisoners of war) or wartime exposure (such as exposure to
Agent Orange or depleted uranium) (JPC, 2011).
All told, the repository includes
· 55 million glass slides.
· 31 million paraffin-embedded tissue blocks.
· 500,000700,000 wet tissue samples.
· 29 tissue microarray assays, each of which may contain hundreds
of specimens.
· over 23 million digitized images of specimens.
· an unknown number of digitized radiologic images.
· other pathology and diagnosis-related holdings, including medico-
legal materials and veterinary specimens.
· associated medical records or other data (Baker, 2011).
There are also 18 freezers that contain frozen samples that were still being
cataloged in early 2012. The materials are housed in climate-controlled
storage facilities in an annex of the Walter Reed Army Medical Center in
Forest Glen, Maryland.
The amount of data associated with specimens depends on when they
were sent to the repository. In recent decades, information accompanying
most accessions in the Central Collection includes patient name, S ocial
Security number, date of birth, repository accession number, surgical num-
ber, type of specimen, contributor's1 health care facility, and specialty
branch numbers associated with the consultation. Other information that
may also be associated with a sample includes age, sex, race, ethnicity,
contributor's working diagnosis, and details of the patient's clinical history
(such as location and size of tumor, symptoms, duration of illness, physical
and laboratory findings, type and date of surgery, and treatments). Data
related to specimens in the BRAC Collection vary because the submitting
military base, rather than the repository, determined which information
was collected, but is typically more limited than in the Central Collection.
1Contributor, in the repository's parlance, is the medical professional (often, a pathologist)
who submits the specimen for consultation or storage. It is not the person from whom the
specimen was obtained.
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SUMMARY 5
It usually includes patient name, where the specimen originated, surgical
number, and diagnosis.
A 2008 assessment of the accuracy and completeness of the AFIP data
bases and analysis of the state of the repository's specimens found that
about 75 percent of retrievals of specimens from the Central Collection
cases yielded the records that were requested (Asterand, 2008). The assess-
ment concluded that the utility of Central Collection specimens for research
purposes depended on the age of the specimen, with the most recently
acquired specimens having the fewest aberrations and the largest amount
of associated clinical data. The vast majority of wet tissue specimens exam-
ined were desiccated and thus of impaired research value. However, tests
suggested that at least one pathology research tool (immunohistochemistry
analysis) could be successfully used with even the oldest of specimens.
The JPC does not have documentation regarding any consent forms
signed by patients or research participants whose data or specimens were
submitted to the repository (Baker personal communication, 2011). 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 (Baker personal communication, 2011).
CONCLUSIONS AND RECOMMENDATIONS
The committee structured the results of its work into three broad cat-
egories. It first offers general observations based on its overall evaluation
of the JPC's future challenges. It then responds to the questions posed in
the DoD's statement of task, dividing them into questions related to the
retention and maintenance of biospecimens and those addressing the future
use of the biospecimens and associated data and medical records in clinical
care, education, and research.
This summary covers the major findings of the committee; more detailed
advice is offered in Chapter 4.
General Observations
The JPC faces major challenges as it transforms into a modern bio
repository that provides clinical consultation, education, and research ser-
vices. Many of these arise from the way in which much of the existing
collection of biospecimens and associated clinical data was obtained. The
challenges include determining the utility of the collection--which consists
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6 FUTURE USES OF THE DOD JPC BIOREPOSITORY
of materials collected, handled, and stored under a variety of c onditions--
and establishing appropriate ethical and legal standards for using the
materials, especially in research, inasmuch as they were generally collected
without source individuals'2 consent for use in research.
The threshold issue that the JPC must confront in facilitating use
of the repository is the uncertainty regarding the utility of its collection of
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 (Compton et al., 2009).
Variations in the preanalytic handling of specimens, in specimen prepara-
tion and fixation, in postfixation handling and storage, and in accompany-
ing documentation greatly affect their suitability for some forms of analysis.
That is not to say that such specimens lack value--almost all have utility
in at least some applications--but it indicates that the operators of such a
repository must be circumspect in their expectations and representations.
Advances in technology will undoubtedly change the criteria for determin-
ing whether particular specimens are fit for purpose in ways that may make
fewer or more of them useful.
The committee recommends that the JPC, as part of its plan for im-
proving 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, consider how to enhance the repository's
value given the JPC's organizational and budgetary constraints, and for-
mulate its retention policy and dissemination management and marketing
strategies accordingly. In this regard, the committee believes that it is crucial
for the JPC to find ways to engage the professional community in discussion
concerning future use of the repository so that it can understand better the
potential demand for collection materials and how to facilitate their use.
The JPC may also wish to consider means such as the "honest broker"
model for providing specimens and data to researchers while protecting the
interests of specimen sources. An honest broker is an individual, organization
or system that serves as neutral intermediary between a provider of materials
(a source individual or biorepository, for example) and r esearchers, collat-
ing pertinent specimens and data, replacing identifying information with a
code, and releasing only coded information to the researchers ( Eiseman et al.,
2003; NCI, 2011). The notion of an honest broker, which has been adopted
2The term source individual (sometimes abbreviated to source) is used in this report to refer
to the person from whom biospecimens and data were obtained. Unlike the term donor, it
does not imply that the person necessarily made a decision about the storage and use of the
materials--such an implication would be mistaken in the case of almost all the materials held
in the JPC repository.
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SUMMARY 7
by some biorepositories, has been applied more generally in facilitating the
dissemination of materials to life-science researchers.
The JPC indicated to the committee that it would like to make reposi-
tory materials available for research on a cost-neutral basis (Baker, 2011).
Because the federal government is in general prohibited from charging non-
government entities for such services,3 the committee recommends that the
JPC 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 Department of Defense (DoD)
leadership to determine the best way to establish such an ability. The com-
mittee notes that other government agencies have used such mechanisms as
partnering with nonprofit organizations (which may accept nongovernment
funds) to provide services that they cannot charge for or to receive funds
from outside parties.
Retention and Maintenance of Biospecimens
General Retention and Maintenance Issues
Advances in tissue-analysis technology continue to be made and no
one can confidently predict the potential future scientific value of particular
repository specimens. However, the possibility that some currently u nusable
material might become useful does not mean that all of the material that
the JPC holds must be stored indefinitely to safeguard against losing some-
thing of possible prospective value. The committee recommends that the
JPC 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 clini-
cal use. The committee recommends that the criteria for determining when
specimens should be disposed of include whether the specimens fall into
any of these categories:
· Wet tissue specimens and slides that have been obviously contami-
nated, desiccated, or otherwise damaged.
· Tissue blocks that have been contaminated, exhausted, dried out,
or have otherwise deteriorated.
· Frozen specimens that show evidence of freezer burn or of having
been melted and refrozen.
· Specimens of any type that cannot be associated with a data record
in the system.
3Federal organizations can recover such costs from other parts of the federal government
through interagency transfers (31 U.S.C. § 1535).
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8 FUTURE USES OF THE DOD JPC BIOREPOSITORY
Auditing the vast holdings of the JPC repository to determine the con-
dition of specimens would be a long and expensive undertaking. The com-
mittee recommends that as long as it is less expensive to retain specimens
than it is to assess their condition comprehensively, specimens be evaluated
only when they are retrieved for clinical, education, or research purposes.
If a specimen is found to satisfy the disposal criteria, it should be removed
from the collection. If and when the cost of retaining specimens exceeds
the estimated cost of auditing the collection, a procedure for setting priori-
ties for review and systematically removing specimens that are not usable
for clinical, education, or research purposes from the collection should be
implemented.
Statutory requirements for retention change, and the committee rec-
ommends that the JPC seek the advice of the DoD Office of the General
Counsel regarding the procedures it should have in place to conform to the
laws in force when implementing disposal policies.
Retention of BRAC Collection Materials
The specimens and data in the BRAC Collection appear no differ-
ent from ones that can be obtained from other sources, such as hospital
and university pathology departments and currently open military health-
care facilities. The information available to the committee suggests that
the BRAC Collection of materials has no greater value for education or
research purposes than the collections of pathology materials found in
hospitals comparable with the facilities that transferred them. Therefore,
the committee recommends that the JPC retain materials in the BRAC Col-
lection for potential clinical consultation only for as long as required by
CAP or CLIPCLIA guidelines4 and requirements, whichever specifies the
longer period.
Use of Biospecimens in Clinical Care, Education, and Research
Ethical and Legal Considerations
Use in clinical care and education The use of the stored biospecimens
and other clinical data in the JPC repository for clinical care of the person
from whom they were obtained is subject to the same ethical and legal
4 The guidelines set forth in the College of American Pathologists (CAP) Laboratory Accredi-
tation Program (CAP, 2010) and DoD's Clinical Laboratory Improvement Program (CLIP)--
which conform to the Centers for Medicare and Medicaid Services Clinical Laboratory
Improvement Amendments (CLIA) certification requirements (42 CFR § 493.1105)--specify
how long biospecimens must be retained to satisfy reasonably anticipatable clinical needs.
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SUMMARY 9
considerations as arise in the management of any clinical pathology collec-
tion. Generally speaking, educational use of repository materials that have
been stripped of all information that would allow sources to be identified
poses no ethical or legal issues and should continue to be facilitated by the
JPC. The committee recommends that dissemination of biospecimens by
the JPC for educational purposes should be subject to strict compliance
with rules and procedures to protect source identity. Those requirements
should be developed and updated to ensure that reidentification of source
individuals cannot readily be accomplished. In addition, material-transfer
agreements and other documents offered to individuals and institutions
seeking access to JPC repository materials (whether for education or other
purposes) should explicitly forbid reidentification efforts.
Use of repository materials for the medical care of other persons--
notably, genetically related persons and persons who have a life experience
(such as an exposure or service in a military unit) in common with the
source--presents special issues that require careful consideration of the rel-
evant ethical and legal issues as well as the circumstances of the request. The
committee recommends that the JPC develop a policy for evaluating such
requests and, when it is appropriate, fulfill them in a manner that protects
the privacy of persons from whom the specimens were obtained. The policy
should include consideration of whether the material can be provided in a
deidentified manner, whether access is necessary to address a medical need
that cannot be equally well met by another available means, and applicable
legal constraints.
Use in research The policy landscape governing research on clinically
collected specimens that are assembled by pathologists and then made
available for research use is in transition. 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. The
committee recommends that the JPC adopt a policy regarding research use
of tissues originally submitted for clinical consultation that places transpar-
ency and respect for source individuals and populations at its core. The
procedures adopted should remain flexible enough to adapt to the chang-
ing 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
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10 FUTURE USES OF THE DOD JPC BIOREPOSITORY
Committee and IRB that the JPC already uses.5 It would be com-
posed 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
obligate the researchers to keep information secure, to avoid
efforts to identify data or specimen sources, and to otherwise
protect the interests of specimen sources and the DoD.
· Solicitation of input from the community of people--in particular,
active-duty military, veterans, and their family members--whose
specimens are held by the repository through, for example, repre-
sentation on the DAC or creation of a community advisory board.
· Notification through public means--for example, posting on its
website, in newsletters, and in other media that reach the military
community and the general public--of the JPC's intention to allow
repository materials to be used for research purposes, including
--examples of the kinds of research that have been done with
repository specimens in the past.
--a description of the oversight and review mechanisms govern-
ing access to the materials that can be easily understood by the
general public.
--a clear statement that no access will be allowed without the
review and approval of an IRB.
--user-friendly means by which people may ask questions or re-
quest that a good-faith effort be made to determine whether the
repository holds specimens from them with the option to request
5The 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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SUMMARY 11
that any specimens be withheld from research use (through, for
example, a Web form, e-mail address, or telephone number
for inquiries).
· Posting, in a forum such as the JPC website, of the active research
projects that are using repository materials. This will promote
accountability to specimen sources and citizens regarding how
repository materials are being used; it will also help to inform the
research community about the repository's collection and potential
research uses.
· Regular review of JPC forms, protocols, and procedures to ensure
that they meet evolving legal and regulatory requirements and re-
flect best practices for biorepository operations and management,
as defined by, for example, the National Cancer Institute (NCI,
2011) and the International Society for Biological and Environ-
mental Repositories (ISBER, 2012).
Protocols and procedures regarding research use of materials should be
public documents and should be regularly updated on the JPC website.
Use of Consultation Materials from Federal Facilities
and Civilian Providers
Access by researchers to human materials that entered the JPC re-
pository from federal facilities and from civilian providers6 is generally
governed by the same legal requirements and ethical standards. Additional
protections regarding research on human subjects, especially requirements
regarding informed consent, do apply to U.S. military service members,
and these impose additional review and procedural responsibilities on the
repository. 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.
Scientific Considerations
Current and emerging technologies Several existing and emerging tech-
nologies in protein and gene-expression profiling and advances in DNA,
elemental, and chemical studies hold the potential for making the JPC
6The 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.
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12 FUTURE USES OF THE DOD JPC BIOREPOSITORY
repository materials more useful by permitting specimens previously con-
sidered unusable to be analyzed or by allowing more information to be
extracted from specimens. However, although the technical ability to ex-
tract and analyze biomolecules from archived specimens has improved and
is likely to increase, the many unknown types and degrees of preanalytic
variation to which the specimens have been subjected before stabilization
will affect the validity of analytic results and may limit many types of re-
search studies.
If the JPC is to fulfill its stated mission to provide "world class"
research services, it will need to establish procedures that minimize the
adverse consequences of inconsistent preanalytic handling of specimens.
The committee therefore recommends that the JPC adopt a set of best prac-
tices for the collection, processing, and storage of all incoming specimens,
either by developing its own standards or by using one developed by an-
other entity--for example, NCI's Best Practices for Biospecimen Resources
(NCI, 2011). As the JPC takes steps to enhance its laboratory information
management system by improving basic search and analytic functionality,
its system should include fields that detail how specimens were collected
and handled before accessioning in the repository, quality-control data, and
what record there is of consent to future research use. There may also be
merit in digitizing all new cases coming to the repository and the committee
suggests that the JPC consider whether it is feasible given economic and
logistical circumstances. And, the committee believes that the JPC would
derive value from pursuing research partnerships with the Department of
Veterans Affairs to examine questions regarding the health consequences
of military service and the determinants of disease and wellness.
Use of rare and unique materials Rare and unique materials in the Central
Collection of the repository are a resource for the JPC, the country, and
the global scientific community. However, the question of what constitutes
rare and unique material is complex: even relatively common diseases have
rare subtypes, for example. Moreover, particular collections of specimens
may be "unique" in the aggregate, although until a particular set of de-
sired material characteristics is defined it may not be possible to determine
whether or not other similar collections are available elsewhere. It is also
difficult to predict what may prove to be valuable at some future time or
under particular circumstances.
The committee recommends that the following considerations be taken
in account in evaluating whether any given specimen should be made avail-
able for research:
· the age of the specimen.
· the disease state that it represents.
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SUMMARY 13
· the specimen's medical, scientific, and historical7 significance.
· the condition of the specimen and its fitness for the proposed use.
· whether a proposed use would exhaust the research potential of
the specimen.
· whether the same research need might be met by another, less rare
specimen or another source of specimens.
· the importance of the public health or military need the proposed
use aims to meet.
The JPC should also develop criteria for determining when a collection
of specimens--rather than an individual sample--is unique or has special
medical, scientific, or historic value, and for managing access to such
collections.
The JPC does not have any specific policy regarding how the depletion
of a repository specimen should be factored into decisions regarding access
to it, beyond ensuring that all applicable retention requirements are met.
That should change to ensure that the repository remains a resource for
otherwise unobtainable material. The committee recommends that the JPC
establish criteria for deciding whether to deplete a specimen to exhaustion.
The criteria should be determined in close consultation with pathology
subspecialty experts in and outside the JPC. Detailed recommendations
are beyond the scope of the present committee's task but the criteria may
include such considerations as the following:
· retaining a set percentage of the tissue-containing portion of a tissue
block unless a designated repository officer authorizes its use.
· retaining a set number of stained or unstained tissue sections from
a specimen.
· not permitting any specimens collected before a given date to be
used for research without specific review of whether the need justi-
fies depletion of the resource and without explicit authorization by
a designated repository officer.
· not disposing of any specimen collected before a given date, no
matter its condition.
Access to Repository Materials
Permitting wide access to the JPC repository materials promotes the
public good through the advancement of medical and scientific knowledge.
7The National Museum of Health and Medicine (http://www.medicalmuseum.mil) houses
military pathology specimens with historical value and would be the authority on this question.
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14 FUTURE USES OF THE DOD JPC BIOREPOSITORY
It also benefits the DoD by fostering the development of information on the
determinants of disease and good health in service members and veterans.
The JPC's mission and vision are focused on the DoD and the rest of
the federal government but do not preclude working with other entities.
The committee does not believe that there are any intrinsic advantages or
disadvantages to any particular set of potential users of the repository's
resources. The committee recommends that there be no a priori restrictions
on which applicants may apply for access to the repository's specimens and
data.
When data or specimens are disseminated to outside investigators,
the JPC must be especially attentive to employing mechanisms to manage
privacy and security issues properly. The committee recommends that the
JPC condition its provision of repository materials to researchers outside
of the federal government on
· 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 par-
ticular project.
· Implementation of data-use agreements and material-transfer
agreements, as appropriate, to help to protect the identified inter-
ests. Data-use and material-transfer agreements 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
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. April 21, 2011 presentation to the Committee
on the Appropriate Use of the Armed Forces Institute of Pathology's Tissue Reposi-
tory Follow ing Its Transfer to the Joint Pathology Center. Washington, DC: Institute of
Medicine.
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SUMMARY 15
CAP (College of American Pathologists). 2010. Retention of laboratory records and ma
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