VA TISSUE STORAGE AND BANKING
Below is the link to the VACO (VA Central Office) ORD (Office of Research and Development [the VA policy makers]) website regarding tissue storage and banking. The site explains both thoroughly and gives specific requirements for each category and type of site:
http://www.research.va.gov/programs/tissue_banking/default.cfm
To summarize if and when a waiver from VACO ORD is required:
Tissue Storage (specimens collected and stored for the life of a single research protocol and only for the use for the specific purposes defined in the single protocol and that are destroyed either when the specific testing/use is completed or at the end of the protocol):
· At VA: preferred; NO WAIVER required
· At UCD or other non-profit or academic institution:
If stored up to 5 years: NO WAIVER required.
If stored longer than 5 years: WAIVER IS REQUIRED.
· At a For-Profit institution:
If stored up to 3 months: NO WAIVER required.
If stored longer than 3 months: WAIVER IS REQUIRED. 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.
Tissue Banking (specimens collected for secondary or future research, beyond the scope of work described in the original protocol and informed consent, or those collected under a protocol designed for banking of specimens):
· At VA: preferred: NO WAIVER required.
· At UCD or other non-profit or academic institution: WAIVER IS REQUIRED before the specimens are banked.
· At a For-Profit, or on behalf of a for-profit, institution: Specimens CANNOT be banked at a for-profit.
Exception: As a result of a letter of understanding with NCI, many NCI-sponsored cooperative tissue banks are designated as VA-approved if they are used for one of their protocols, e.g., SWOG, RTOG, CALGB, NCCTG. Here is a link for the complete list: http://www.research.va.gov/programs/tissue_banking/approved.cfm#2