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 expanded and diversified in the years that followed, setting up a Pathology Department and Instructional Laboratory in 1910 and undertaking an extensive effort to document the medical consequences of combat during World War I. Several registries—collections of rare or representative biospecimens from a particular organ system or representing a specific medical condition—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 Institute 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 biospecimens 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 recommended in 2005 that AFIP be disestablished except for some components,
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
Questions Posed in the Committee’s Statement of Task
- Given 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 consultation, 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 nonviable 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 submitted 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 manner 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?
the Appropriate Use of AFIP’s Tissue Repository Following Its Transfer to the Joint Pathology Center, provides responses to those questions.
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 Sciences 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 committee’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 committee’s findings, conclusions, and recommendations presented in Chapter 4.
Background information on the biorepository’s collection is summarized below.
As of 2011, the JPC tissue repository comprised some 7.4 million accessions 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 materials 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 provision of routine medical care. About two-thirds of the so-called BRAC Col-
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.
- 500,000–700,000 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, Social Security number, date of birth, repository accession number, surgical number, 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.
It usually includes patient name, where the specimen originated, surgical number, and diagnosis.
A 2008 assessment of the accuracy and completeness of the AFIP databases 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 assessment 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 examined 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).
The committee structured the results of its work into three broad categories. 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.
The JPC faces major challenges as it transforms into a modern biorepository that provides clinical consultation, education, and research services. 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
of materials collected, handled, and stored under a variety of conditions—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 preparation and fixation, in postfixation handling and storage, and in accompanying 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 determining 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 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, 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. 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 researchers, collating 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.
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 repository materials available for research on a cost-neutral basis (Baker, 2011). Because the federal government is in general prohibited from charging nongovernment entities for such services,3the 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 committee 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 unusable material might become useful does not mean that all of the material that the JPC holds must be stored indefinitely to safeguard against losing something 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 clinical 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 contaminated, 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).
Auditing the vast holdings of the JPC repository to determine the condition of specimens would be a long and expensive undertaking. The committee 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 priorities 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 recommends 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 different from ones that can be obtained from other sources, such as hospital and university pathology departments and currently open military healthcare 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 Collection for potential clinical consultation only for as long as required by CAP or CLIP–CLIA 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
4The guidelines set forth in the College of American Pathologists (CAP) Laboratory Accreditation 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.
considerations as arise in the management of any clinical pathology collection. 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 relevant 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 transparency and respect for source individuals and populations at its core. The procedures adopted should remain flexible enough to adapt to the changing 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
Committee and IRB that the JPC already uses.5 It would be composed 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, representation 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 governing 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 request 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.
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 reflect 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 Environmental 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 repository 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.
Current and emerging technologies Several existing and emerging technologies 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.
repository materials more useful by permitting specimens previously considered unusable to be analyzed or by allowing more information to be extracted from specimens. However, although the technical ability to extract 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 research 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 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). 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 desired 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 available for research:
- the age of the specimen.
- the disease state that it represents.
- 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 justifies 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.
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 particular project.
- Implementation of data-use agreements and material-transfer agreements, as appropriate, to help to protect the identified interests. 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.
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