VA Tissue Banking Guidance
As of April 1, 2017, ORD is not reviewing any more applications for off-site tissue banking or storage of VA biospecimens. The program is ceasing. This was always a voluntary program and not considered official VA policy. Please refer to the guidance documents provided on this website for additional information on specimen banking/storage.
If an application has been submitted for review of off-site tissue banking or storage of VA biospecimens prior to that time, it will be reviewed and evaluated no later than April 30, 2017.
**The discontinuation of the off-site specimen banking/storage waiver program does NOT mean that specimens collected from VA research may not continue to be stored/banked outside of the VA. This determination would ultimately be made by the IRB, VA R&D committee and ACOS at your facility.
ORD has scheduled three webinars to be held on the following dates listed below to answer questions related to the termination of the voluntary off-site tissue banking waiver program that occurred on April 1st and address human subject protection issues associated with storage of VA biospecimens at both VA and non-VA institutions. Any materials will be sent through the VA AO/ACOS or RCO listserv. If you are not on this these listservs please contact Kristina Hill at Kristina.firstname.lastname@example.org for this information.
Dial in: 800-767-1750, code: 78462
Adobe Connect: Adobe connect link: http://va-eerc-ees.adobeconnect.com/r391s6iz4ol/
(1) April 27, 2017 from 2:00 p.m. EST to 3:00 p.m. EST; webinar slides
(2) May 11, 2017 from 2:00 p.m. EST to 3:00 p.m. EST; webinar slides
(3) May 23, 2017 from 2:00 p.m. EST to 3:00 p.m. EST; webinar slides
The following Material Transfer Agreement draft guidance is being sought for public comment. Please direct any comments or questions electronically within 45 days of its issue to email@example.com.
- DRAFT guidance on Material Transfer Agreements
- Human Biological Specimens Used for VA Research - This guidance document describes human biological specimens in regards to their use in VA research.
ORD Guidance on Information to Include in a Biorepository Protocol - This guidance document focuses on components of a protocol for VA research biorepositories that are established for future use.
- ORD Guidance on Stewardship of VA Research Biorepositories - This guidance document refers to the responsible management and care-taking responsibility of biorepositories or biobanks.
- ORD Guidance on Registration of VA Research Biorepositories - This guidance document applies to research biorepositories or biobanks maintained in VA space, or otherwise financially supported by VA, for the intended purpose for future research use. See also Instructions for Registering a VA Research Biorepository on the Smithsonian's GRSciColl Website
ORD Guidance on What to Include in an Informed Consent Document When Banking VA Biospecimens for Research
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