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Tissue Banking Policies. January 2008. 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

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human biological specimens
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
banked specimens
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
non banked human biological specimens
Non-Banked 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

  • Important Notes:
    • If specimens are stored off-site at a non-profit institution 5 years, then the investigator must obtain a waiver from ORD.
    • If specimens are stored off-site at a non-academic, for-profit institution for >3 months, a waiver must be obtained from ORD.
non banked specimens
Non-Banked Specimens
  • If the specimens are sent to a non-VA institution for testing as defined in the protocol, once the specific analyses are performed, the remainder of the specimens must be destroyed or returned to the VA for destruction.
  • If the specimens are destroyed at another institution, that institution must certify the destruction of the specimens in writing.
de identified
De-identified

De-identified data is health or other information about an individual that:

  • Does not contain any of the 18 HIPAA identifiers

AND

  • Is de-identified according to the Common Rule

Coded information is not considered de-identified if the tissue bank or data coordinating center has access to the codes.

on site tissue banks
On-Site Tissue Banks
  • A tissue bank established at a VA site by a VA-paid investigator does not require ORD approval.
  • The ACOS/R or research office should maintain records of all tissue banks within the facility.
on site tissue banks cont d
On-Site Tissue Banks (cont’d)
  • If a VA site does not have the resources to bank specimens, then they may be banked at any VA site that has an established tissue bank.
  • Alternatively, specimens may be banked at the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) core laboratory at the Boston VA. It serves as the Cooperative Studies Program (CSP) Genetic Tissue Core Laboratory.
  • Either option is considered on-site banking.
off site tissue banks
Off-Site Tissue Banks
  • The researcher must obtain a waiver from ORD before banking human biological specimens at an off-site location.
  • Off-site tissue banks are approved on a per protocol basis.
  • Exception: National Cancer Institute (NCI)-sponsored cooperative tissue banks listed on the next slide. As a result of a letter of understanding with the NCI, these banks are designated as VA-approved if they are used for one of their protocols (for example, the SWOG-supported tissue bank can be used for SWOG protocols without ORD approval).
va approved nci tissue banks
VA-Approved NCI Tissue Banks
  • Clinical Trials Cooperative Groups Tissue Resources
    • American College of Surgeons Oncology Group (ACOSOG)
    • Cancer and Leukemia Group B (CALGB)
    • Eastern Cooperative Oncology Group (ECOG)
    • Gynecologic Oncology Group (GOG)
    • North Central Cancer Treatment Group (NCCTG)
    • National Surgical Adjuvant Breast and Bowel Project (NSABP)
    • Radiation Therapy Oncology Group (RTOG)
    • Southwest Oncology Group (SWOG)
    • National Cancer Institute of Canada Clinical Trials Group(NCIC CTG)
  • Cooperative Breast Cancer Tissue Resource
  • Cooperative Human Tissue Network
  • Gynecologic Oncology Group Tissue Network
  • Cancer Prevention Network
banked specimens1
Banked Specimens
  • Specimens may not be banked at a non-academic, for-profit institution
  • Specimens must be labeled with a code that does not contain any of the 18 HIPAA identifiers.
  • The key to the code must be maintained at the VA unless there is a compelling reason otherwise.
data related to banked specimens
Data Related to Banked Specimens
  • If data linked to the sample leaves the VA, then it must be de-identified or stored in a database that is encrypted according to FIPS 140-2 standards.
  • See VA Handbook 6500 “Information Security.”
non banked specimens stored at non academic for profit sites
Non-Banked Specimens Stored at Non-Academic For-Profit Sites
  • If the specimens are held for >3 months, then a waiver must be obtained from ORD.
  • Only analyses/tests listed in the protocol and informed consent may be performed.
  • The code must be maintained at the VAMC.
  • All specimens and associated data must be de-identified.
  • DNA and RNA may not be analyzed.
  • The company must inform the PI in writing when samples are destroyed.
non banked specimens stored at non academic for profit sites cont d
Non-Banked Specimens Stored at Non-Academic For-Profit Sites (cont’d)
  • HIPAA authorization must expire.
  • Case reports may not contain initials if they leave VA.
  • Specimens must be destroyed upon request of the subject.
  • Before company personnel may view files at the VA, they must complete VA security and privacy training.
  • Specimens must be destroyed within 1 year of the study completion date.
multi site trials
Multi-Site Trials
  • If several VAMCs are planning to participate in the same clinical trial, then only one of the VA sites needs to apply for a waiver.
  • A list of multi-site clinical trials in which more than one VAMC is participating is posted on the VA R&D web site. (http://www.research.va.gov/programs/tissue_banking)
informed consent
Informed Consent
  • Several elements must be included in an informed consent when the protocol involves banking–either on-site or off-site– of human biological specimens.
  • The elements are important for transparency to the subject.
  • The list of elements is posted on the VA R&D web site, and some are given on the next slide.
informed consent cont d
Informed Consent (cont’d)
  • Some informed consent elements
    • Types of samples stored and length of time to be stored
    • Name and location of tissue bank
    • Types of future studies
    • Subject may withdraw from the study and request that his/her samples be destroyed
    • If the specimen will be shared with other researchers for approved research protocols
informed consent cont d1
Informed Consent (cont’d)
  • The informed consent does not need to narrowly specify the future uses of the banked specimens.
  • But if it is not specific, in the consent form or during the consent process, the PI should explain what such phrases as “related diseases” or “unspecified research” means for the use of the sample and the impact on the subject.