Va Form 10-0436 - Application For An Off-Site Tissue Banking Waiver At A Non-Profit Or Academic Institution Page 3

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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
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