Management of the Department of Veterans Affairs Biorepository Assets
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1 Management of the Department of Veterans Affairs Biorepository Assets Marianna J. Bledsoe, M.A. Senior Program Manager for Biorepositories and Biobanking Office of Research and Development, (ORD) Department of Veteran Affairs IOM Workshop on Appropriate Use of AFIP s Tissue Repository July 11,
2 Relevant VA Regulations and Policies Common Rule Codified for VA at Title 38 CFR Part 16 VA Handbooks VA Tissue Banking Guidelines 2
3 Relevant VA Policies VHA Handbook Requirements for the Protection of Human Subjects in Research VHA Handbook Use of Data and Data Repositories in VHA Research VHA Handbook Privacy and Release of Information VHA Handbook Minimum Necessary Standard for Protected Health Information VA Handbook Information Security Program VHA Handbook Pathology and Laboratory Medicine Service Procedures 3
4 VA Specimen Banking Guidelines Current requirements found on VA Office of Research and Development web site: e_banking/default.cfm Address off-site storage Handbook on use of specimens and data currently under development 4
5 VA Specimen Banking Projects/Goals Million Veteran Program Cooperative Studies Program Banked Specimens Solid Tissue Specimen Banks: ALS Other Virtual banking network (long term goal) 5
6 Project Specific Policies Million Veteran s Program Veterans treated in VA facilities consented prospectively for use of genomic specimens and data in research Broad consent Consent for re-contact to participate in new studies Specimens will be analyzed and results made available to investigators Policies still under development 6
7 Project Specific Policies ALS Bank Post-mortem bank from consented donors Review of requests by committee of experts, VA Central Office staff Available to qualified researchers (VA, academia, for-profit) 7
8 Project Specific Policies Cooperative Studies Program (CSP) Banked Collections Specimens available from CSP studies one year after initial study has been completed Proposals for use of banked specimens for genetic studies reviewed by Genetics subcommittee of the CSP Scientific Evaluation Committee Currently, applicants must have a VA appointment Reviewing current collections to determine if they can be made more broadly available Standardized access and review procedures and policies for all banks under development 8
9 Veterans Perspectives Studies on veteran s perspectives related to specimen and data research: Damschroder LJ, Pritts JL, Neblo MA, Kalarickal RJ, Creswell JW, Hayward, RA. Patients, privacy and trust: patients willingness to allow researchers to access their medical records. Soc Sci Med 2007; 64: DiMartino L, Allen K, Kasarskis E, Lindquist JH, Coffman CJ, Oddone EZ, Characteristics associated with participation in DNA banking: the National Registry of Veterans with ALS. Contemporary Clinical Trials 2007; 28: Kaufman D, Murphy J, Erby L, Hudson K, Scott J. Veterans attitudes regarding a database for genomic research. Genetics in Medicine 2009; 11:
10 Survey of Research on Health Records High willingness to share health records with researchers: 89% VA researchers 75% university researchers Veterans concerned about whether: The research being conducted really helps veterans; overall impact on society; scientific value Researchers are committed to protecting privacy Higher level of comfort if information stays within the VA Veterans want to be informed about what research is being done using their medical records Most participants willing to allow use of deidentified records for research Soc Sci Med 2007; 64:
11 Survey About Genomic Database for Research Widespread support for genomic database: 84% of Veterans who receive care through VA Access by US academic researchers: 80% Access by other governmental researchers: 71% Access by pharmaceutical researchers: 54% Access by researchers in other countries: 43% Support for research on broad range of topics, including mental illness, PTSD, alcoholism Respondents were split on one-time consent vs. consent for each study Genetics in Medicine 2009; 11:
12 Q1. In general, do you agree or disagree with following statement? It is a good idea to use leftover blood or tissue for research purposes. Strongly agree Agree Disagree Strongly disagre Unpublished data GPPC 12
13 Take Home Messages Importance of: privacy trust and transparency governance and oversight Caveat: surveys addressed research on health records, DNA and prospective development of database for genomic research not secondary use of specimens and data collected during routine care Limitation of surveys: Answers depend on how questions are asked Fundamental rule of biobanking : Context is key! 13
14 AFIP Repository: Potential Strategies to Consider to Address Veteran s Interests Consider holding focus groups on Veteran s perspectives about the use of the AFIP repository Engage Veteran community in the development of operating procedures and policies of the AFIP repository Establish governance and oversight mechanisms to ensure Veteran s interests are protected Include Veteran representation Establish rigorous privacy protections including: only disclose de-identified data; minimum necessary for the research Certificate of Confidentiality 14
15 AFIP Repository: Potential Strategies to Consider to Address Veteran s Interests Consider Veteran s perspectives when developing access criteria for use of specimens and data from the repository (e.g. importance of research to diseases in Veterans, overall society and scientific value) Consider Veteran s perspectives when developing policies for priority to access Use by non-profits, researchers outside the US Provide appropriate stewardship and accountability including: Use of Material Transfer Agreements or other contractual agreements stipulating conditions of use; signed by recipient investigator and institution 15
16 AFIP Repository: Potential Strategies to Consider to Address Veteran s Interests Provide transparency of operating procedures and policies, research uses, etc. by publishing on publicly available website; newsletters Create a website that includes lists/descriptions of studies and results of studies for which AFIP specimens are being used Pay special attention to specimens 16
17 AFIP Repository: Final Questions and Points to Consider Issues related to consent/waiver of consent Need to better understand Veteran s perspectives; consider additional focus groups/surveys Need to consider practicability, ease of recontact, potential bias; privacy issues related to any re-contact Governance and oversight critical How to address issues of stewardship/ownership of collections when they are from multiple sources 17
18 AFIP Repository: Final Questions and Points to Consider Engagement of key stakeholders essential: Tissue Donors Active duty military Military dependents Veterans, including military retirees and their dependents Civilians Government Organizations DoD, VA, HHS, EPA, others Academic research community For-Profit research community
19 AFIP Repository: Final Questions and Points to Consider Access to AFIP collections may help address issues of particular interest to VA: Military occupational exposures Agent Orange 1991 Gulf War Current conflict (Burn Pits) Jet fuel Environmental contamination at military installations Prisoners of War General health consequences of PTSD Neurotrauma
20 Summary Development of AFIP repository policies will require balancing multiple interests of the military, Veterans and key stakeholders in the civilian community Access to AFIP collections important to VA research objectives 20
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