Sections 1 to 4: site and people
The VA medical center's station number, name and location, the VA principal investigator, the ACOS for Research and Development and the person completing the form.
10-0436
Application for an Off-Site Tissue Banking Waiver at a Non-Profit or Academic Institution
- Agency
- VA
- Revision
- March 2009
- Fillable fields
- 74
- Pages
- 7
- Official source
- VA form page
- Checked
- October 20, 2026
VA Form 10-0436: Off-Site Tissue Banking Waiver at a Non-Profit or Academic Institution
VA Form 10-0436 is the U.S. Department of Veterans Affairs Application for an Off-Site Tissue Banking Waiver at a Non-Profit or Academic Institution. It is a VA research form: a VA principal investigator's study team uses it to ask VA Central Office to approve banking biospecimens outside VA, for example at a university or NIH-sponsored biorepository, as the form puts it. VA's form page lists it under VHA.
The instructions say to use it only when the specimens will be stored for future research beyond the original protocol and consent, or collected under a banking protocol, when they will be banked at a non-profit or academic institution, and when a for-profit sponsor will not receive them. The PDF has seven pages: instructions, Sections 1 to 13 on the study, specimens, data and submission, and a page of definitions. You can fill out the PDF free in your browser on this page and download the result without an account.
What's on VA Form 10-0436
Sections 5 and 6: tissue banks and study
Name, location and website of up to two tissue banks, then the study title, planned enrollment at the site, sponsor, grant number, start and end dates, other participating centers and whether IRB and R&D Committee approval depend on the waiver.
Section 7: biospecimens
Types of specimens and how long they will be banked, whether the consent covers future research, how specimens are secured, the code used to label them and who holds and secures the key to the code.
Section 8: study data
Whether any data, including clinical and demographic data, x-rays and scans, will be sent or stored outside VA, whether it is de-identified, and how data that is not de-identified will be transferred.
Sections 9 to 12: justification and sign-off
The reason for using a non-VA repository, what happens to specimens when the bank closes or a subject withdraws, comments, the required documentation list, the Research Office contact and the PI certification.
Section 14: definitions
The list of 18 HIPAA identifiers and the form's definition of de-identified data, which for VA research purposes meets the criteria of both HIPAA and the Common Rule.
How to complete VA Form 10-0436
- 1
Check that the application applies
The instructions list three conditions to confirm before using it: future research use or a banking protocol, a non-profit or academic bank, and no specimens sent to a for-profit sponsor.
- 2
Answer every question
The form asks for an answer to all questions, with N/A where a question does not apply. Extra information that would help the review goes in Section 9D.
- 3
Gather the documentation
Section 10 lists the research protocol, the informed consent form and separate HIPAA authorization, the bank's policies or the Tissue Bank Operations Form, and the IRB and R&D Committee approval letters.
- 4
Add the PI certification
The principal investigator types their name in Section 12 to verify the application was reviewed for accuracy and completeness.
- 5
Send it to the Research Office
Email the application and the Section 10 documents to the Research Office, which forwards it to Central Office. The form says electronic applications are preferred.
Why fill Form 10-0436 on indox
You get the real form, filled in a browser tab, with nothing standing between you and the finished PDF.
- Fill the form right in your browser, no software to install
- Free to fill and free to download, with no account
- The official blank straight from the VA, not a copy someone retyped
- Works on a phone, tablet or computer
Where it goes and contacts
Local Research Office
The instructions say to email the completed application to the ACOS/R or designated person in the Research Office.
Central Office address
Department of Veterans Affairs, Biomedical Laboratory R&D Service (121E), 810 Vermont Avenue, NW, Washington, DC 20420.
Email, phone and fax
Section 13 lists the email [email protected], phone 202-443-5675 and fax 202-495-6181, and says electronic applications (via e-mail) are preferred.
Edition
The PDF footer reads MARCH 2009 on each of its seven pages.
Related forms
10-0455a
Clinical Trial Inclusion/Enrollment Report
63 fields, 1 page
10-1086
Research Consent Form
7 fields, 1 page
10-250
VHA Research Protocol Privacy Review Checklist
94 fields, 5 pages
10-0398
Research Protocol Safety Survey
627 fields, 12 pages
10-1223
Report of Subcommittee on Human Studies
22 fields, 1 page
10-1313-1
Merit Review Application
65 fields, 1 page
Who uses VA Form 10-0436?
The form names the people and offices involved. It is filled in about a study, not by the study's subjects.
Official sources and the blank
Do it all with indox
No tool matches that search.
Questions about Form 10-0436
Who submits VA Form 10-0436?
The study team of a VA principal investigator. The instructions say to email it to the ACOS/R or designated person in the Research Office, which forwards it to Central Office.
When is this application used?
The instructions say it is for specimens kept for future research beyond the original protocol and consent, or collected under a banking protocol, banked outside VA at a non-profit or academic institution, with no specimens sent to a for-profit sponsor.
Does each participating VA medical center send its own application?
No. Section 6 says only one application should be submitted for all participating VA Medical Centers.
Can the IRB and R&D Committee approval letters come later?
Section 10 says that if IRB and R&D Committee approval are contingent upon the waiver, those letters may be sent after ORD has approved the application.
How are the biospecimens to be labeled?
The form says the specimens are labeled with a code that does not contain the subject's name, initials, SSN or anything derived from the 18 HIPAA identifiers listed in Section 14.
What does the form mean by de-identified?
Section 14 says that for VA research purposes, data are de-identified only if they meet the criteria of both HIPAA, with all 18 identifiers removed, and the Common Rule. Coded data are not de-identified if the recipient has the key.