VA Form 10-0474 Application for Biospecimen Storage at a for-Profit Institution

VA Form 10-0474 or the "Application For Biospecimen Storage At A For-profit Institution" is a form issued by the United States Department of Veterans Affairs.

The form was last revised on January 1, 2011 - an up-to-date fillable PDF VA Form 10-0474 down below or find it on the Veterans Affairs Forms website.

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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
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
5. BIOSPECIMEN STORAGE
Name of institution where the biospecimens will be stored
Location of institution where biospecimens will be stored (city, state/country)
6. INFORMATION ABOUT THE STUDY
Title of the study
No. of subjects you plan to enroll at this
site:
Study sponsor(s)
Start date
End date
Please describe in detail the studies/analyses that will be performed on the biospecimens.
Are other VA Medical Centers participating in this study?
NO
YES
Is IRB and R&D Committee approval contingent upon this waiver?
NO
YES
7. INFORMATION ABOUT THE BIOSPECIMENS
Types(s) of biospecimens collected and stored (e.g., blood, lung tissue,
How long will the biospecimens be
stored? (They may be stored up to 1
buccal swab, DNA)
year after the completion of the study.)
How are the biospecimens secured? (locked freezer, locked room, etc.)
VA FORM 10-0474
JANUARY 2011
Page 2 of 4
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 4.
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.
8. INFORMATION ABOUT THE STUDY DATA
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
If YES, state where and why it needs to be outside the VA.
Comments (additional information that would help us review your application)
9. DOCUMENTATION
The following documentation is required, in addition to this completed form:
­Research protocol
­Informed consent form and accompanying HIPAA authorization
­IRB approval letter*
­Written notification of approval from the ACOS for R&D, or 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
this application has been approved.
10. RESEARCH OFFICE CONTACT
Person in the research office who forwarded this application
Last Name, First Name
Phone
E-mail
11. 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.
VA FORM 10-0474
JANUARY 2011
Page 3 of 4
SUBMISSION OF APPLICATION
Kristina Hill, MPH, MT(ASCP)
Forward this completed application and the
documentation listed in section 9 to your
Department of Veterans Affairs
Research Office.
Biomedical Laboratory R&D Service (121E)
The Research Office should forward the
810 Vermont Avenue, NW
application to Kristina Hill in Central
Washington, DC 20420
Office.
E-mail:
offsite.tissuebanking@va.gov
Phone: 202-443-5675
Electronic applications (via e-mail) are
preferred.
Fax: 202-495-6181
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.”
VA FORM 10-0474
JANUARY 2011
Page 4 of

Download VA Form 10-0474 Application for Biospecimen Storage at a for-Profit Institution

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