1. Tissue Banking Marilyn Mason, Ph.D. March 3, 2009

2. 2 Human Biological Specimens  Any material derived from a human subject—such as blood, urine, tissues, organs, hair, nail clippings, or any other cells or fluids  Whether collected for research purposes or as residual specimens from diagnostic, therapeutic, or surgical procedures  Does not include fungi, viruses, bacteria, etc.

3. 3 Non-Banked (Stored) Human Biological Specimens Human biological specimens collected under a VA-approved protocol that are used for only the specific purposes defined in the protocol and are destroyed when the specific testing/use is completed or at the end of the protocol

4. 4 Banked Specimens  Biological specimens collected and stored for future research purposes that are beyond the scope of work described in the original protocol and informed consent OR  Biological specimens collected under a protocol designed for banking of specimens

5. 5 New Handbook  Establishes policies and procedures for the collection of human biological specimens for research purposes, the re-use of previously collected research specimens, and the storage of human biological specimens for future research use  Addresses the collection and storage of clinical and research data that may be linked to those specimens

6. 6 Background Information  Federal regulations and VA policy  Biorepository best practices  Survey of veterans on their attitudes about genomic medicine  Genomic data in genome-wide association studies (GWAS) databases  Genetic Information Nondiscrimination Act (GINA)

7. 7 Federal Regulations and VA Policy  Common Rule  HIPAA Privacy Rule  VHA Handbook 1605.1--Privacy and Release of Information  VHA Handbook 1200.05--Requirements for the Protection of Human Subjects in Research  VA Handbook 6500--Information Security Program  VHA Handbook 1106.01—Pathology and Laboratory Medicine Service Procedures

8. 8 Biorepository Best Practices  International Society for Biological and Environmental Repositories (ISBER) “2008 Best Practices for Repositories” http://www.isber.org/Pubs/BestPractices2008.pdf http://www.isber.org/Pubs/BestPractices2008.pdf  National Cancer Institute Best Practices for Biospecimen Resources (June 2007) http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Pr actices_060507.pdf http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Pr actices_060507.pdf

9. 9 Survey of Veterans  >900 veterans from across the country, who receive care through the VA, completed a survey on their attitudes about genomic medicine  Included in the survey were questions about use of biological specimens for genetic studies by VA researchers, university researchers, and drug companies

10. 10 Survey of Veterans, cont’d  83% veterans agreed that the genomic medicine program should be done  71% were willing to participate  Majority of veterans thought that the following types of researchers outside of the VA should have access to VA samples and data (in order listed): –US academic or medical centers –Other health-related government agencies –US pharmaceutical companies

11. 11 Genome-Wide Association Study (GWAS)  A genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition.

12. 12 GWAS Data  A research team at the Translational Genomics Research Institute (TGen) has developed bioinformatics techniques so that with enough genomic data on an individual from another source, it is possible to determine if that individual participated in the study by analyzing the pooled data.

13. 13 GWAS Data, cont’d  As a result of this, in August, NIH modified part of its policy for posting and access to genomic data in its GWAS databases.  White paper at http://grants.nih.gov/grants/gwas/ http://grants.nih.gov/grants/gwas/

14. 14 GWAS Data, cont’d  To protect research participant privacy, NIH removed aggregate GWAS files from the public portion of its databases.  The data is still available to researchers, but they must now apply for access to the data and sign a data use agreement, in which they agree to protect the confidentiality of the data.

15. 15 GINA  Signed into law on May 21, 2008  Protects individuals against discrimination based on their genetic information in health coverage and in employment  Requires that Office for Civil Rights modify the Privacy Rule to explicitly provide that genetic information is health information under the Privacy Rule and to prohibit most health plans from using or disclosing genetic information for underwriting

16. 16 Status of New Handbook  Went into concurrence the beginning of September 2008  Has been revised based on feedback  New policies regarding banking at for-profit companies will not be implemented until after handbook has been approved  Current requirements found on ORD web site http://www.research.va.gov/programs/tissue_ba nking/default.cfm http://www.research.va.gov/programs/tissue_ba nking/default.cfm

17. 17 Guidance Documents  Guidance, application forms, and checklists will be in guidance document(s) that will be posted on the ORD web site when the handbook is approved and posted.  If there is anything you would like us to include in the guidance, please let me know.

18. 18 What Handbook Covers  Specimens banked outside of the VA –At non-profit or academic institution –At for-profit company  Specimens banked at a VA facility –PI-dedicated biorepository –Shared biorepository  Non-banked specimens sent outside of the VA for analyses/testing

19. 19 Banking at For-Profit Companies  VA PI must obtain approval from Central Office  Company must enter into a cooperative research and development agreement (CRADA) with the VA  Banking must be part of an interventional clinical trial that is registered with ClinicalTrials.gov

20. 20 Banking at For-Profit Companies, cont’d  Banking must not be a requirement of participation in the trial  A separate consent form for banking is required  Banked specimens must be labeled with a code that does not contain any of the 18 HIPAA identifiers before they leave the VA

21. 21 Banking at For-Profit Companies, cont’d  The HIPAA authorization must have an expiration date  Company may have a limited data set, if they sign a data use agreement  Individual raw genetic data resulting from company’s analyses must be encrypted according to FIPS 140-2 standards  Company may share specimens only with its affiliates (not with other parties)

22. 22 On-Site Biorepositories  Must have a master banking protocol (We are currently developing a template.)  Must undergo an annual compliance audit (ACOS/R will determine who will perform the audit at his/her facility.) We will provide a checklist. The results must be sent to ORO and ORD.  Two types: PI-dedicated and shared

23. 23 On-Site Biorepositories, cont’d  For shared type –If samples shared with investigators outside the VA, then must use materials transfer agreement (MTA) or MT CRADA. –For data (de-identified or limited data set) leaving VA, a data use agreement (DUA)/data transfer agreement (DTA) is required.

24. 24 Handbook Revisions  The PI requesting an off-site tissue banking waiver does not need to be 5/8ths VA. However, if the PI is WOC, then a VA-paid researcher must agree to take overall responsibility of the specimens.  The person responsible for the annual audit of on-site tissue banks will be designated by the ACOS.  Added section on transfer of specimens from one VA tissue bank to another.

25. 25 Addition to Tissue Banking Team  Kristina Hill, MPH, has joined our staff.  She is processing off-site tissue banking applications so that we can reduce the turnaround time.  Kristina is also helping prepare the guidance documents.  Kristina.Hill@va.gov Kristina.Hill@va.gov

26. 26 Contact Information  Marilyn.Mason@va.gov Marilyn.Mason@va.gov  Phone: 202-461-1682  Fax: 202-254-0521