VA Form 10-0436: Off-Site Tissue Banking Waiver Application – Veterans Affairs (VA) research often involves collecting and banking biological specimens (biospecimens) like blood, tissue, or DNA for future studies that advance medical knowledge and improve care for Veterans. VA Form 10-0436 was a key document in this process for researchers seeking to bank specimens off-site.
What Is VA Form 10-0436?
VA Form 10-0436 is titled “Application for an Off-Site Tissue Banking Waiver at a Non-Profit or Academic Institution.” It is a 7-page fillable PDF form (dated March 2009) used by VA principal investigators (PIs) to request approval for storing VA-collected biospecimens at external non-profit or academic tissue banks, such as universities or NIH-sponsored biorepositories.
The form ensures compliance with privacy (HIPAA), security, and ethical standards while allowing specimens to support broader research beyond the original study protocol.
Download the official form here:
VA Form 10-0436 PDF
Important Update: The Off-Site Waiver Program Has Ceased
As of April 1, 2017, the VA Office of Research and Development (ORD) stopped reviewing new applications for off-site tissue banking waivers under this program. It was always a voluntary program and not official VA policy.
- Pending applications submitted before the cutoff were reviewed by April 30, 2017.
- Existing waivers remain in effect.
- VA biospecimens can still be banked or stored off-site with appropriate approvals from your local Institutional Review Board (IRB), VA R&D Committee, and Associate Chief of Staff for Research (ACOS).
Researchers should consult current VA guidance documents on human biological specimens, biorepository protocols, stewardship, registration, and informed consent for biospecimens.
Who Needs This Form (or Similar Documentation)?
- VA Principal Investigators at VA Medical Centers conducting research involving biospecimen banking.
- Studies where specimens are collected for future research uses beyond the original protocol or under a dedicated banking protocol.
- Non-profit or academic sponsors (for-profit restrictions apply).
It does not apply to specimens sent to for-profit companies in most cases.
Key Requirements and Eligibility Criteria
Before completing the form (historically), applicants had to confirm:
- Specimens are for future research purposes.
- Banking occurs at a non-profit or academic institution.
- Proper informed consent and HIPAA authorization are in place.
- Specimens are coded (no direct identifiers) and the code key is maintained securely at the VA.
- Data sent off-site must be de-identified where possible, with secure transfer methods.
The form collects details on:
- VA Medical Center and PI information.
- Tissue bank name, location, and URL.
- Study title, sponsor, enrollment, and timelines.
- Biospecimen types, storage duration, and security.
- Plans for subject withdrawal, bank termination, and additional justifications.
Required supporting documents typically include the research protocol, informed consent/ HIPAA forms, tissue bank policies, IRB/R&D approvals, etc.
How to Complete and Submit VA Form 10-0436 (Historical Process)?
- Fill out the form using Adobe Reader.
- Answer all questions (use “N/A” if not applicable).
- Provide detailed information in Section 9 for justification and additional details.
- Attach required documentation.
- Submit to your local VA Research Office, which forwards it to Central Office (historically to [email protected]).
Note: Contact your local VA Research Office or the ORD Regulatory mailbox ([email protected]) for current procedures, as the centralized waiver review no longer applies.
HIPAA Identifiers and De-Identification
The form emphasizes strict adherence to HIPAA. It lists 18 identifiers that must be removed for data to be considered de-identified. Coded specimens are not de-identified if the recipient has access to the linking key.
Current VA Biospecimen Banking Guidance
VA provides detailed resources on:
- Human Biological Specimens Used for VA Research.
- Biorepository protocols and stewardship.
- Registration of VA biorepositories.
- Informed consent language for banking.
Local IRBs and R&D committees play the primary role in approving off-site storage today.
Why Proper Tissue Banking Matters for Veterans?
Responsible biospecimen banking accelerates discoveries in cancer, genetics, chronic diseases, and personalized medicine—directly benefiting Veterans. Strict controls protect privacy and maintain trust in VA research.
For the latest policies, visit the official VA Research site: VA Tissue Banking Guidance.
Questions? Reach out to your VA facility’s Research Office or the ORD Regulatory team. Always verify requirements with current official sources, as policies evolve.
This article is for informational purposes only and is based on publicly available VA resources. It is not legal or regulatory advice.