Tissue Banking

1
Tissue Banking

• Marilyn Mason, Ph.D.
• January 14, 2009

2
Human Biological Specimens

• Any material derived from a human subjectsuch 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
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
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
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
New Handbook, contd

• Went into concurrence the beginning of September
  2008
• Is being revised based on feedback and will go
  back into concurrence in about a week
• 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_banking
  /default.cfm

7
Guidance Documents

• Guidance, application forms, and checklists will
  be in guidance documents 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.

8
What Handbook Covers

• Non-banked specimens sent outside of the VA for
  analyses/testing
• Specimens banked at a VA facility
• PI-dedicated biorepository
• Shared biorepository
• Specimens banked outside of the VA
• At non-profit or academic institution
• At for-profit company

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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

10
Banking at For-Profit Companies, contd

• 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

11
Banking at For-Profit Companies, contd

• 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
  companys analyses must be encrypted according to
  FIPS 140-2 standards
• Company may share specimens only with its
  affiliates (not with other parties)

12
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

13
On-Site Biorepositories, contd

• 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.

14
Background Information

• Regulations
• Biorepository best practices
• Survey of veterans on their attitudes about
  genomic medicine
• Genomic data in genome-wide association studies
  (GWAS) databases

15
Regulations

• Common Rule (38 CFR Part 16)
• HIPAA Privacy Rule (45 CFR 164)
• 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

16
Biorepository Best Practices

• International Society for Biological and
  Environmental Repositories (ISBER) 2008 Best
  Practices for Repositories http//www.isber.org/P
  ubs/BestPractices2008.pdf
• National Cancer Institute Best Practices for
  Biospecimen Resources (June 2007)
  http//biospecimens.cancer.gov/global/pdfs/NCI_Bes
  t_Practices_060507.pdf

17
Survey of Veterans

• gt900 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

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Survey of Veterans, contd

• 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

19
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.

20
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.

21
GWAS Data, contd

• 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/

22
GWAS Data, contd

• 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.

23
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_at_va.gov

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Contact Information

• Marilyn.Mason_at_va.gov
• Phone [phone]
• Fax [phone]