VA ECHCS
VA ECHCS (Attachment S1)
Human Biological Specimens Questionnaire
(for storage and/or banking)
______
Principal Investigator:
Project Title:
This appendix should be completed only if the proposed research project will be either collecting human biological specimens or using previously collected (banked) human biological specimens.
Note: Information regarding VA requirements may be obtained by contacting Lynne Brandes at r Connie Steinbrunn at .
Definitions:
- Human biological specimen (HBS): any material derived from human subjects, such as blood, urine, tissues, organs, hair, nail clippings, or any other cells or fluids, whether collected for research purposes or as residual specimens from diagnostic, therapeutic, or surgical procedures.
- “Stored” Specimen: specimens collected only for the purposes stated in the current protocol, and which will be destroyed at the completion of this study. These specimens are not considered banked specimens.
- “Banked” Specimen: specimens collected and stored for future research purposes are considered “banked” specimens.
- On-site tissue bank: a tissue repository or storage facility established in a VA facility by a VA-paid investigator. It contains human biological specimens collected under VA-approved research protocols that are under both VA ownership and VA control.
- VA-approved off-site tissue bank: an approved tissue bank located at a non-VA facility and has the appropriate approval from the Chief Research & Development Officer (CRADO) at the VA Central Office. Off-site tissue banks are approved on a per protocol basis, with the exception of some National Cancer Institute (NCI) -sponsored tissue banks. (See Attachment C for the VA Central Office’s “FAQ: Banking of Human Biological Specimens for Research” for more information and a list). Non-VA sites that may not be acceptable include non-academic, for-profit institutions, such as pharmaceutical companies.
Basic Information on Type and Source of Specimens:
1. What type of human biological specimens will be collected in this research project?
- Please select the source of the human biological specimens to be used in this research project: Check all that apply.
Specimens will be collected under this protocol
Clinical specimens from an indicated diagnostic or therapeutic procedure
Specimens previously collected under an IRB approved protocol
Provide the following for the IRB-approved protocol under which the samples were collected:
Title of protocol under which specimens were originally collected:
Dates of COMIRB protocol approval:
Attach a copy of the most recent approved consent form for that protocol, even if that
protocol has been closed.
(Note: If the previously approved protocol does not include the purposes and procedures for which this protocol will be using the human biological specimens, the COMIRB may place restrictions on the manner in which the specimens are linked to the clinical data.)
Data
3. Will the data generated from the human biological specimens be linked to the clinical data?
Yes No (skip to question 7)
If Yes to 3, answer the following:
- Will the specimens be linked to clinical data at the VA ECHCS? Yes No
- Will the specimens be linked to clinical data at other VA’s? Yes No
- Will the specimens be linked to clinical data at other institutions? Yes No
- Will the data be de-identified? (not contain any of the 18 HIPAA identifiers) Yes No
4. If Yes to 3C, please answer the following:
(1) Justify why the clinical data needs to be viewed by investigators outside the VA ECHCS:
(2) Where will the data be analyzed?
(3) Who will be analyzing the data?
(Note: If the data will be sent to another institution to be linked, the minimal amount of clinical data should be shared with those doing statistical analysis and should not contain ANY subject identifiers.)
5. Describe in detail how the link will be maintained:
6. How will patient confidentiality be maintained?
Note: If the data is not de-identified, the database must be encrypted with VA-approved encryption software.
Specimen Access and Security
7.Please provide the following information regarding the storage of the specimens:
(1)How will the specimens be secured?
(2)How will the specimens be labeled? (information that will be required on label)
8. List the names (first, last, and degree) of individual(s) having access to the data and/or specimens:
Specimen Analysis and/or Banking:
9. State where the samples will be analyzed and/or stored (use 9A and 9B as necessary if multiple sites are involved):
(1) Name and Location of institution:
(2) Address of institution (if not VA ECHCS):
(2) Building:
(3) Room:
At this institution, samples will be: Analyzed Banked for future studies
If this institution is outside of the VA ECHCS, is the institution an approved National Cancer
Institute-approved tissue bank?YES NO
If NO and if the non-VA institution is a non-academic, for-profit institution, samples cannot be stored greater than 3 months.
9A. (1) Name and Location of institution:
(2) Address of institution (if not VA ECHCS):
(2) Building:
(3) Room:
At this institution, samples will be: Analyzed Banked for future studies
If this institution is outside of the VA ECHCS, is the institution an approved NCI-sponsored cooperative tissue bank? YES NO
If NO and if the non-VA institution is a non-academic, for-profit institution, samples cannot be stored greater than 3 months.
9B. (1) Name and Location of institution:
(2) Address of institution (if not VA ECHCS):
(3) Building:
(4) Room:
At this institution, samples will be: Analyzed Banked for future studies
If this institution is outside of the VA ECHCS, is the institution an approved NCI-sponsored cooperative tissue bank?YES NO
If NO and if the non-VA institution is a non-academic, for-profit institution, samples cannot be stored greater than 3 months.
NoteIf you have marked that samples will be analyzed or stored at a non-VA and/or a non-NCI-approved tissue bank, the PI and VA PI must write a letter to the lab director at the non-VA site that includes the items listed below. These guidelines apply to all VA human biological specimens. The PI and the VA PI of the study have the ultimate responsibility for ensuring that human specimens from the VA study subject are handled according to VA guidelines.
The following items must be addressed in this letter:
Note: A VA PI must sign off on all documentation associated with this agreement.
- All of the tests that will be done on the specimen(s) should be described in detail. A statement that unspecified testing will be done or might be done is not acceptable.
- The exact purpose and rationale for the testing must be specified.
- The letter must state when the specimen is going to be destroyed.
- This information must be in the protocol, consent form, and COMIRB protocol application.
- A copy of the original letter should be forwarded to the lab director at the non-VA
site performing the testing for signature.
- Once the lab director at the non-VA site, the local PI, and the VA PI sign off on the
letter agreeing to the above conditions, the original letter should be forwarded to the
VA Research Office (A009/151) and a copy kept in the investigator files.
- This entire letter process must be completed before any specimens are collected from VA subjects.
When the testing and destruction of the specimen(s) has been completed, a letter
acknowledging that all samples have indeed been destroyed should be signed by the lab
director of the non-VA site, the local PI and the VA PI. The original letter should be forwarded
to the VA Research Office (A009/151) and the PI and VA PI should keep a copy of this
letter for their study files.
Also, a letter from the VA investigator must be submitted to Dr. Robert Keith, ACOS/R&D, in the VA Research Office stating that he/she understands and agrees to adhere to the VHApolicies for storing human specimens from VA subjects. This letter should be submitted regardless of whether or not the PI is submitting a full application. (Please see Attachment A for a template of this letter.)
10. Did you state that specimens would be banked for future studies in question(s) 9, 9A, or 9B?
Yes No
Note: If you have marked that samples will be banked for future studies at a non-VA institution, please note thatVA policy prohibits the use of a tissue bank that is at a non-academic, for-profit company, such as pharmaceutical companies.
If you marked No, this means that all specimens will be destroyed at the completion of the study or after standard clinical procedures are completed.
If you marked Yes ANDif the tissue bank does not meet the criteria of a VA-approved tissue bank, then
the tissue bank must be approved by the VA Central Office, prior to final study approval and initiation. In
order to request approval, an Off-Site Tissue Banking Waiver is necessary and you must complete VA
Form 10-0436 ( which is a fillable pdf.
The additional information requested on Page 5 of the application can be scanned and attached to
the pdfform which can be emailed to ). Alternatively, the form and requested information can be mailed to the address given on the form. Please make sure that you send the following documents that are listed on Page 5 of the application. Central Office cannot review your application until they receive them.
- Biographical sketch of the PI
- Research protocol
- Tissue bank manual or SOPs
- VA consent form
REQUIRED ELEMENTS FOR THE INFORMED CONSENT FORM
If your study is collecting human biological specimens, please ensure that all items in Attachment B are addressed in the consent form.
For more information, please see Attachment C for the VA Central Office’s “FAQ: Banking of Human Biological Specimens for Research” or call the VA Research Office at 303-399-8020 ext. 2755.
INVESTIGATOR ASSURANCES
- I will maintain a copy of the signed consent form under which the specimen was collected.
- I will maintain a record for a minimum of 10 years describing the use/disposition of each specimen and the protocols under which the specimens are used, as well as the IRB approval of the protocol.
- If the specimens are sent outside the VA ECHCS for the analyses as described in the protocol, I assure that the specimens will be used for approved purposes only, and that upon completion of use of the specimens, I assure that they will be destroyed by the institution or returned to the VA ECHCS for storage or destruction.
Additional Investigator Assurances for the Banking of Specimens For Future Research Use
- These specimens will be banked in a VA-approved tissue bank. If the proposed tissue bank is not currently VA-approved, I will not start the study until the proposed tissue bank has been approved by the VA Central Office.
- The reuse of these specimens will be consistent with the consent under which they were collected, and the re-use will only occur through a VA-approved protocol.
______
VA InvestigatorDate
ATTACHMENT A
Template of letter from VA Investigator to ACOS/Research
(Date)
Robert Keith, MD
Assistant Professor of Medicine
Associate Chief of Staff for Research and Development
VA Eastern Colorado Healthcare System
Research Service/151
1055 Clermont
Denver, CO 80220
RE: COMIRB Protocol #:
VA Investigator:
Title:
Dear Dr. Keith,
This letter is to certify that I, ______(VA Investigator)understand my responsibilities as a (principal investigator or co-investigator) and VA responsible investigator and liaison for the study described above. As the VA Eastern Colorado Health Care System ______(department/title), I will be recruiting veterans with ______(disease or condition) to be subjects in this study. I will be meeting with ______(other PIs or Co-PIs) frequently to discuss the study progression.
I am familiar with the VA guidelines regarding veteran’s tissue samples and I will ensure that the tissue samples from VA subjects are handled according to the guiding principles for storing tissue at an off-site facility. The justification for sending these samples to ______(place samples will be stored) is for the purpose of ______. The privacy and confidentiality of the VA subjects will be upheld as described in the VA research consent form.
Signed,
(Name of PI and full address)
- 1 -10/17/12