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VA Tissue Banking Program
A human biological specimen is 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.
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 those collected under a protocol designed for banking of specimens are considered banked biological specimens.
Human biological specimens collected under a VA-approved protocol are not considered to be "banked" specimens if they are used for only the specific purposes defined in the protocol and are destroyed either when the specific testing/use is completed or at the end of the protocol.
Important Notes:
- If the protocol is 5 years or longer and the specimens are stored off-site at a non-profit institution until the end of the protocol, then the investigator must obtain a waiver from the Office of Research and Development (ORD).
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If the specimens are stored off-site at a non-academic, for-profit institution for greater than 3 months, a waiver must be obtained from ORD.
A tissue bank established at a VA site by a VA-paid investigator does not require approval from ORD. The ACOS/R or research office should maintain records of all tissue banks within the facility
A researcher must obtain a waiver from ORD before banking human biological specimens outside of the VA. In general, an off-site tissue bank must be approved for each protocol. Below is a list of off-site tissue banks that have been approved for multi-site protocols.
The informed consent for a protocol involving tissue banking should contain the elements listed below.
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