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4 Findings, Conclusions, and Recommendations
Pages 109-136

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From page 109...
... 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 were obtained.
From page 110...
... The PSL Core uses a number of privacy safeguards for its database: it may be accessed only via a password provided to qualified investigators, data transmissions are encrypted, all data are de identified and coded with link-backs to repository specimens and data held on a separate fire-wall-protected system, users are limited in how much information they can access on specific specimen sources, and data access is further limited if a query returns only a small number of source individuals who meet the search criteria (Drake et al., 2007)
From page 111...
... The ability to provide such services would of course be dependent on the availability of the requisite expertise and any organizational and budgetary constraints. 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 in privacy and confidentiality.
From page 112...
... There is no documentation of the nature and extent of the consents by source individuals for future use associated with the JPC's existing biospecimens, associated data, and medical records. The challenge is to determine under what conditions previously archived materials may now be used for research and to devise policies and practices that reflect that determination and to govern future collection of biospecimens and medical information in a way that complies with relevant and evolving legal and ethical standards.
From page 113...
... b. Paraffin blocks and wet tissue specimens may be returned to the original contributor upon request.
From page 114...
... That prospect depends not only on the refinement or development of technologies but on whether the materials held by the JPC turn out to be worth examining in comparison with those held by other sources, such as more modern biorepositories and hospital or university pathology departments. Several existing and emerging technologies in morphology, RNA, DNA, and bioinformatics -- detailed in Chapter 2 -- hold the potential for making JPC repository materials more useful than they are now by permitting specimens previously considered unusable to be analyzed or by allowing more information to be extracted from specimens.
From page 115...
... (CAP, 2010) Slides Permanently Cytology: Permanently stained slides -- microbiology: 5 years 7 days Histology: Cytogenetics -- permanently stained: 3 years 10 years Cytology: 5 years Surgical pathology: 10 years Fine-needle aspiration: 10 years Nonforensic autopsy: 10 years Forensic autopsy: permanently Cytogenetics fluorochrome-stained: discretion of laboratory director Paraffin 10 years; 2 years Surgical pathology: 10 years blocks representative Nonforensic autopsy: 10 years samples of Forensic autopsy: permanently returned specimens are retained Wet 10 years Until diagnosis is Surgical pathology: 2 weeks after final tissue obtained report Nonforensic autopsy: 3 months after final report Forensic autopsy: 1 year Cytogenetics: until adequate metaphase cells are obtained Other Discarded Clinical Urine: 24 hours pathology or retained and gross Serum­heparinized or EDTA plasma­ materials at the JPC's radiographic cerebrospinal fluid­body fluids: 48 hours discretion diagnostic Peripheral blood smears­body-fluid materials: smears: 7 days 2 years Cytogenetics fixed-cell pellet: 2 weeks after final report Body fluids­tissues for toxicology: 1 year Patient test records: 2 years Cytogenetics diagnostic images: 20 years Accession log: permanently Gross photographs/negatives: permanently Representative tissue suitable for DNA analysis: permanently Pathology Permanently No specific Surgical pathology: 10 years reports requirements Cytology: 10 years Nonforensic autopsy: 10 years Cytogenetics: 20 years Forensic autopsy: permanently
From page 116...
... suggests that almost all wet tissue specimens are in poor condition: a survey of materials found that more than 99 percent of such specimens accessioned in 1917­1969 and more than 72 percent of those in 1970­2002 were completely desiccated. The committee suggests that the JPC prioritize the review of wet tissue specimens in any audit of the holdings that it conducts and that it consider conduct 9Such specimens may still be useful for light microscopy.
From page 117...
... The committee suggests that the JPC prioritize the review of frozen tissue specimens in any audit of the holdings that it conducts and that it consider conducting a focused audit of frozen materials to remove specimens that show evidence of past melting or freezer burn. If the audit of specimen quality suggests that the frozen tissue resources are potentially useful, the JPC should ensure that the freezers are being maintained according to current laboratory practice guidelines (ISBER, 2012; NCI, 2011)
From page 118...
... Furthermore, for research that requires data beyond what is contained in pathology department records, it will typically be easier to use material obtained from medical facilities -- which will possess accompanying medical records linked to the specimens -- than materials from the BRAC Collection, for which the medical records may not be held by the JPC. Finally, the one characteristic that is sometimes mentioned as a reason
From page 119...
... The ethical and legal considerations regarding use of the repository in the support of clinical care and education depend on the circumstances of the proposed use. 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 considerations as arise in the management of any clini
From page 120...
... Those requirements should be developed and updated to ensure that reidentification of source individuals cannot readily be accomplished. In addition, material-transfer agreements11 and other documents offered to individuals and institutions seeking access to JPC repository materials (whether for education or other purposes)
From page 121...
... The Department of Health and Human Services (HHS) Office for Human Research Protections has determined that deidentified specimens and data collected for clinical care can be used for research without patient consent because such work is not considered research on human subjects (HHS, 2008)
From page 122...
... 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.
From page 123...
... · 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 16Procedures for withdrawing data and materials from research use are in place in other repositories of military biospecimens, including the collection maintained as part of the Depart ment of Veterans Affairs Million Veteran Program (http://www.research.va.gov/resdev/ mvp/veterans.cfm)
From page 124...
... The JPC can also suggest that physicians who seek consultations with the JPC use consent forms that include this language and can ask the contributing physician for information about research consent from the source individual as part of the Contributor's Consultation Request Form and code that information in the JPC database for future use. Several model educational materials (NCI, 2012b)
From page 125...
... . Regulatory requirements for waiver of consent under the Common Rule are set forth in 45 CFR 46.116(d)
From page 126...
... Can tissue within the repository from civilian providers be utilized in the same manner as that from federal facilities? Access by researchers to human materials that entered the JPC repository from federal facilities and from civilian providers20 is generally governed by the same legal requirements and ethical standards.
From page 127...
... . The committee is thus uncertain whether these research methods can successfully be applied broadly to the JPC repository collection and whether the collection will be the best source for investigators seeking to exploit the new technologies.
From page 128...
... As the JPC takes steps to enhance its laboratory information management system by improving basic search and analytic functionality, its system should, at a minimum, 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. If the JPC contemplates moving beyond basic management of the repository to support clinical, educational, and research use toward more active involvement in research or enhancement of its collection by adding new data generated by researchers, the committee suggests that it consider investing in high-performance computing technologies to assist in processing the volumes of data that will be produced.
From page 129...
... Use of Rare and Unique Materials What considerations should be given to utilization for research of unique, one-of-a-kind, material within the central collection of the Tissue Repository? Rare and unique materials in the Central Collection of the repository are a resource for the JPC, the country, and the global scientific community.
From page 130...
... 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. 23The National Museum of Health and Medicine (http://www.medicalmuseum.mil)
From page 131...
... Such a requirement would need to be predicated on the JPC's developing the infrastructure to manage such returns. Access to Repository Materials 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?
From page 132...
... 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
From page 133...
... 2007. A system for sharing routine surgical pathology specimens across institutions: the Shared Pathology Informatics Network.
From page 134...
... :79-161. JPC (Joint Pathology Center)
From page 135...
... 2008. Honest broker certification process related to the de-identification of health information for research and other duties/ requirements of an honest broker.


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