Fillable Printable VA Form 10-0436
Fillable Printable VA Form 10-0436
VA Form 10-0436
Application for an Off-Site Tissue Banking
Waiver at a Non-Profit or Academic Institution
INSTRUCTIONS
This form may be filled in and saved using Adobe Reader version 7.0 or higher. The full version of Adobe
Acrobat is not needed.
When you have completed the application, please e-mail it to the ACOS/R or designated person in your
Research Office. The Research Office should forward the application to Kristina Hill in Central Office.
Please answer all questions. If a question does not apply, please insert “N/A.” Additional information that would
help us review your application should be added on page 5 in section 9D.
Before using this application, make sure that the following apply:
The biological specimens will be collected and stored for future research purposes that are beyond the
scope of work described in the original protocol and informed consent or the biological specimens will be
collected under a protocol designed for banking of specimens.
Biospecimens will be banked outside of the VA at a non-profit or academic institution (e.g., university or
NIH-sponsored biorepository).
The study is sponsored by a non-profit institution or if the study is sponsored by a for-profit company,
biospecimens will not be sent to the company.
1. VA MEDICAL CENTER
A. Station no. B. Name and location (city, state)
2. VA PRINCIPAL INVESTIGATOR
A. Last name, first name B. Degree(s) C. VA paid status
D. Telephone E. E-mail
3. ACOS FOR RESEARCH AND DEVELOPMENT
A. Last name, first name B. Degree(s)
C. Telephone D. E-mail
4. PERSON COMPLETING THIS FORM
A. Last name, first name B. Degree(s)
C. Telephone D. E-mail
VA FORM 10-0436
MARCH 2009
Page 1 of 7
WOC
VA FORM 10-0436
MARCH 2009
Page 2 of 7
5. TISSUE BANK(S)
If biospecimens are going to be stored at more than one tissue bank, please give the name, location, and
URL for each.
A1. Name of tissue bank A2. Name of 2nd tissue bank, if applicable
B1. Location of tissue bank (city, state) B2. Location of 2nd tissue bank, if applicable
C1. URL of tissue bank web site C2. URL of 2nd tissue bank, if applicable
6. INFORMATION ABOUT THE STUDY
A. Title of the study
B. No. of subjects you plan to enroll at
this site:
C. Study sponsor D. Grant or award no. E. Start date
F. End date
G1. Are other VA Medical Centers participating in this study?
YES NO NOT SURE
G2. If Yes, please name the other Centers, if known. Note: Only one application should be submitted for all
participating VA Medical Centers.
H. Is IRB and R&D Committee approval contingent upon this waiver?
YES NO
7. INFORMATION ABOUT THE BIOSPECIMENS
A. Types(s) of biospecimens collected and banked ( e.g., blood, lung
tissue, buccal swab, DNA )
B. How long will the biospecimens be
banked?
VA FORM 10-0436
MARCH 2009
Page 3 of 7
C1. Have biospecimens already been sent to the tissue bank named in section 5 above?
YES NO
C2. Are the biospecimens being banked at the VA until the off-site tissue bank is approved?
YES NO
D1. Does the informed consent under which the biospecimens were collected specify that they will be used for
future research?
YES NO
D2. If YES, specify the type of future use (e.g., any study on this disease/condition, any future study, genetic
studies, etc.).
E1. Will all future uses of VA biospecimens be done through VA-approved protocols?
YES NO
E2. If NO, provide a clear description of the reasons and the mechanisms used by the bank to distribute
biospecimens to researchers, including a description of the oversight.
F. How are the biospecimens secured? (locked freezer, locked room, etc.)
The biospecimens MUST be labeled with a code that does not contain the subject’s name, initials, SSN,
or anything derived from the 18 HIPAA identifiers listed on page 6.
F. Describe the code used to identify the samples (e.g., bar code or study site number followed by a hyphen and
5 random numbers and letters). Note: Subject’s initials are a HIPAA identifier and may not be used as part
of the code.
VA FORM 10-0436
MARCH 2009
Page 4 of 7
G1. Will the key to the code that links the biospecimens to the subject's identity be maintained ONLY at the VA
facility?
YES NO
G2. If NO, indicate where else a copy of the key will be maintained and why. (Exceptions are not routinely
approved.)
H1. Who has access to the key? (PI, study coordinator, data coordination center director, etc.)
H2. Are any of the people who have access to the key outside of the VA?
YES NO
H3. If YES, who? (study coordinator, data coordination center director, etc.)
I. How is the key secured at all locations? (locked file cabinet, in a password-protected database that is
encrypted, etc.)
8. INFORMATION ABOUT THE STUDY DATA
A1. Will any data be sent or stored outside of the VA? (Data includes clinical and/or demographic data, as well as
x-rays and scans.)
YES NO (skip to section 9)
A2. If YES, state where and why it needs to be outside the VA.
A3. If YES, will the data be de-identified? (Please see the definition of de-identified on page 6 of this form.)
YES (skip to section 9) NO
B. If data leaving the VA is NOT de-identified according to the definition on page 6 of this form, it must be
transferred in a secure manner. Indicate how the data will be transferred (VPN, encrypted e-mail).
VA FORM 10-0436
MARCH 2009
Page 5 of 7
C. If any of the HIPAA identifiers will be stored in an off-site database, the database should have limited access
and be encrypted. It should be clearly stated in the HIPAA authorization what will be stored. Social security
numbers should NOT be stored in an off-site database unless required for billing purposes (any other requests
will be handled on a case by case basis). Social security numbers may NOT be stored in a for-profit company's
database.
9. ADDITIONAL INFORMATION
A. Provide the justification for banking biospecimens at a non-VA repository.
B. Upon termination/closing of the bank, what will happen to veterans’ biospecimens?
Biospecimens will be destroyed.
Biospecimens will be returned to the originating VA facility.
Other. Please provide an explanation.
C. If the subject withdraws from a study, what will happen to his/her biospecimens and data?
Biospecimens will be destroyed except for any de-identified samples that have been shared with other
researchers. The research team will continue to use any information that they have already collected
from the subject to ensure the integrity of the research. However, no new information will be collected
from the subject.
Biospecimens and all data linked to that subject will be destroyed.
D. Comments (additional information that would help us review your application)
VA FORM 10-0436
MARCH 2009
Page 6 of 7
10. DOCUMENTATION
The following documentation is required, in addition to this completed form:
Research protocol
Informed consent form and separate HIPAA authorization
Information regarding the bank’s policies, mechanisms of tissue acquisition and redistribution, and all
oversight mechanisms in place (or complete the Tissue Bank Operations Form).
IRB approval letter*
R&D Committee approval letter*
*If IRB and R&D Committee approval are contingent upon this waiver, these approval letters may be sent to us
after ORD has approved this application.
11. RESEARCH OFFICE CONTACT
Person in the research office who forwarded this application
Last Name, First Name
Phone: E-mail:
12. PI CERTIFICATION
By typing his/her name in the space below, the PI verifies that he/she has reviewed this application for accuracy
and completeness.
13. SUBMISSION OF APPLICATION
Forward this completed application
and the documentation listed in
section 10 to your Research Office.
The Research Office should forward
the application to Kristina Hill in
Central Office.
Electronic applications (via e-mail)
are preferred.
Kristina Hill, MPH, MT(ASCP)
Department of Veterans Affairs
Biomedical Laboratory R&D Service (121E)
810 Vermont Avenue, NW
Washington, DC 20420
E-mail:
Phone: 202-443-5675 Fax: 202-495-6181
VA FORM 10-0436
MARCH 2009
Page 7 of 7
14. DEFINITIONS
HIPAA Identifiers
Names and initials
All geographic subdivisions smaller than a state
All elements of dates (except year) for dates directly related to an individual
Telephone numbers
Fax numbers
E-mail addresses
Social security numbers or parts of them, scrambled or unscrambled
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web URLs
Internet Protocol (IP) address numbers
Biometric identifiers, including fingerprints and voiceprints
Full-face photographic image
Any other unique identifying number
De-identified Data
De-identified data is health information that does not identify an individual and there is no reasonable basis to
believe that the information can be used to identify an individual.
VHA would consider health information no longer protected health information (PHI) if it has been appropriately
de-identified in accordance with the HIPAA Privacy Rule as outlined in VHA Handbook 1605.1, Appendix B. For
protected health information to be de-identified, all of the 18 HIPAA identifiers listed above must be removed.
HIPAA identifiers also pertain to the person's employer, relatives, and household members. Along with removing
the 18 identifiers, HIPAA also states that for the information to be considered de-identified, the entity does not
have actual knowledge that the remaining information could be used alone or in combination with other
information to identify an individual who is the subject of the information.
According to the Common Rule (
http://www.access.gpo.gov/nara/cfr/waisidx_98/38cfr16_98.html), de-
identification involves removal of all information that would identify the individual or would be used to readily
ascertain the identity of the individual.
Note : For VA research purposes, VA research data are considered to be “de-identified” only if they meet the de-
identification criteria of BOTH HIPAA (i.e., removal of all 18 identifiers) AND the Common Rule.
Note : If the recipient of the biospecimens or the data has access to the key to the code, the coded information is
not considered “de-identified.”
