Va Form 10-0474 - Application For Biospecimen Storage At A For-Profit Institution

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Application for Biospecimen Storage at a
For-Profit Institution
INSTRUCTIONS
This form may be filled in and saved using Adobe Reader version 6.0 or higher. The full version of Adobe
Acrobat is not needed.
Additional information that would help us review your application should be added on page 3, #8 under comments.
To apply for storage of biospecimens at a for-profit institution for >90 days, the response to each of the
following MUST be YES:
 Only analysis/tests described in the protocol and informed consent will be performed. The specimens will not be
used for future studies.
YES
NO
(
 All specimens and associated data will be de-identified.
They must be labeled with a code that does not contain
.)
any of the 18 HIPAA identifiers listed on page 4
YES
NO
 The key to the code that links the biospecimens to the subject’s identity will be stored ONLY at the VA Medical
Center.
YES
NO
 If genetic material, (e.g., DNA, RNA, other) is studied, only unique clearly delimited genetic products will be
studied. Genome-wide association studies will not be performed.
YES
NO
 Biospecimens will be destroyed within 1 year of the study completion date.
YES
NO
 The company will inform the PI in writing when samples are destroyed.
YES
NO
 The subject’s biospecimens will be destroyed upon his/her request.
YES
NO
 Case reports will not contain initials if they leave the VA Medical Center.
YES
NO
1. VA MEDICAL CENTER
Station no.
Name and location (city, state)
2. VA PRINCIPAL INVESTIGATOR
Last name, first name
Degree(s)
VA paid status
WOC
Telephone
E-mail
3. ACOS FOR RESEARCH AND DEVELOPMENT
Last name, first name
Degree(s)
Telephone
E-mail
4. PERSON COMPLETING THIS FORM
Last name, first name
Title
Telephone
E-mail
VA FORM 10-0474
JANUARY 2011
Page 1 of 4

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