VA Tissue Banking Guidance
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.
Collecting and Storing Specimens for Secondary or Future Research
Requirements for collecting and storing human biological specimens 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 as follows:
- A waiver is not needed if human biological specimens are banked at a VA site.
- Human biological specimens may be stored for secondary or future research uses at a non-profit or academic institution, if a waiver is obtained from the Office of Research and Development (ORD) before the specimens are banked. Click on the non-profit link below for the application and more information.
- Human biological specimens cannot be stored for future or secondary research uses at, or on behalf of, a for-profit institution. Please refer to the section below for other options.
Collecting and Storing Specimens for a Single Research Protocol
Requirements for collecting and storing human biological specimens that are collected under a VA-approved protocol only for use for the specific purposes defined in the protocol and that are destroyed either when the specific testing/use is completed or at the end of the protocol are as follows:
- 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 ORD.
- If the specimens are stored off-site at a for-profit institution for greater than 3 months, a waiver must be obtained from ORD. With a waiver the specimens may be stored for up to 1 year after the study completion date, to perform batch analyses or to repeat analyses that are described in the protocol and informed consent. Click on the for-profit link below for the application and more information.
VA-Approved Tissue Banks
In the past, if a tissue bank was designated VA-approved, human biological specimens could be stored there for any protocol. That is no longer the case. Currently, an off-site tissue bank waiver must be approved for each protocol. We maintain a list of academic and non-profit tissue banks that have been approved for multi-site protocols. If you are planning to participate in a multi-site study, click here to view the list.
Exceptions: As a result of a letter of understanding with the National Cancer Institute (NCI), many NCI-sponsored cooperative tissue 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 a waiver from ORD). Click here to view the list.
Tissue Banking Program Contact Information
Kristina Hill, MPH, MT(ASCP)
Department of Veterans Affairs
Biomedical Laboratory Research and Development (10P9B)
810 Vermont Avenue, N.W.
Washington, D.C. 20420