OHR-15
12/2012
Thomas Jefferson University Institutional Review Board
Request for Human Biological Specimens for Research
Use of identified human tissue and biological specimens collected for research purposes is subject to IRB
review. This includes discarded/previously stored surgically removed tissue, tumors, blood, urine, etc.
Please provide a written protocol with the OHR-15. Form must be typed.
Study Title:
Principal Investigator:
Department:
Division:
Contact Person:
Email address:
Phone/Extension:
CCRRC APPROVAL
1. Does the scope of your research involve cancer (patients, tissue, data, blood, charts, etc.)?
[ ] YES
[ ] NO
2. If you marked “YES” for question 1, please certify that the KCC Protocol Coversheet has been completed and
submitted to the CCRRC (Clinical Cancer Research Review Committee). Also please include a copy in the
IRB submission.
[ ] YES
[ ] NO
3. Please also confirm that your trial has been approved by the CCRRC or has been given a waiver from CCRRC
review. Also please include a copy of the CCRRC approval or waiver email in the IRB submission.
[ ] YES
[ ] NO
YOU MAY NOT SUBMIT TO THE IRB UNTIL YOU HAVE CCRRC APPROVAL or WAIVER. Contact the
CRMO at 955-9244 for more information.
____________________________________________________________________________
1. Is your laboratory certified as a BL 2 facility?
[ ] Yes
[ ] No
If No, contact the Institutional Research Biosafety Officer at 215-503-7422 to arrange an inspection for
certification.
2. Is this research being funded by any outside sponsor?
Yes ______ No ______
If, yes, who is providing the funds?___________________________________
3. If the protocol involves sending tissue to a commercial entity, please certify that the following criteria are
met (see TJU policy #110.17, “Collection, storage, use and distribution of tissue for research purposes”). Also,
please provide a copy of the sponsor contract/agreement or an e-mail from ORA certifying same.
The PI certifies that he or she (check applicable statements):



Will have significant input into the study design and/or conduct of the study.
Will receive experimental data and participate in data analysis.
Has established the right to be a co-author on any publications related to this protocol.
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4. Type Of Specimen(s) Requested:
[]
[]
[]
[]
Blood [ ] Urine [ ] Sputum [ ] Other (specify)__________________
Tissue (specify type)____________________
Tumor (specify type)____________________
Tissue/tumor specifications: [ ] Fresh Sterile [ ] Forman-fixed [ ] Other____________
5. Number Of Specimens Desired: ___________.
6. Specimens allocated for research purposes may reduce the amount of material available for clinical
analysis, future storage or testing. Please justify why the amount of tissue you need is the minimal amount
necessary.
7. Where Will Specimens Be Obtained? (provide department, location, and supervisor of lab or storage
facility)
8. Who has authorized your collection of specimens, if they are not from your lab? Please provide name
and contact information for this person.
9. If specimens are not currently stored in your lab, provide a detailed explanation of how they will be
obtained.
10. Explain your plan to protect identifiers.
11. This request is for:
[ ] Specimens that already exist/are currently stored (retrospective)
[ ] Specimens to be obtained in the future (prospective)
12. If you propose to use stored research specimens, was informed consent initially obtained?
[ ] Yes
[ ] No
[ ] Do not know
12. Purpose Of Specimen Collection (Describe succinctly):________________________
_____________________________________________________________________
13. Please list names of all individuals involved with study/project.
Name
Precise Role/Duties in Study
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14. If tissue is to be coded and identifiers will be maintained in a separate file or location, please describe
the coding mechanism.
15. Will Biological Specimens be released outside the institution? Yes _____ No _____
If yes, please specify who will receive the specimen, for what purpose, and whether identifying
information will be released. (Informed consent is required to release specimens with identifiers outside
of the institution). If biological materials are to be sent outside of the institution, contact the Office of
Technology Transfer as a Material Transfer Agreement might be necessary.
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
16. Will the specimens be stored/banked for future use? Yes _____ No ______
If yes, where will the tissue be stored? What future types of research would you anticipate?
_____________________________________________________________________
______________________________________________________________________
17. HIPAA (Health Insurance Portability & Accountability Act) Privacy Rule Protections:
The following items are categorized as identifiers under the Privacy Rule regulations. Please check off
which of the following will be obtained:






Patient/Subject Name







Telephone number
Address street location
Address town or city*
Address state*
Address zip code*
Elements of Dates (except year) related to an individual. For example, date of birth, admission or
discharge dates, date of death*
Fax Number
Electronic mail (email) address
Social security number
Medical record numbers
Health plan beneficiary numbers
Account numbers
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



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


Certificate/license numbers
Vehicle identification numbers and serial numbers including license plates
Medical device identifiers and serial numbers
Web URLs
Internet protocol (IP) address
Biometric identifiers (finger and voice prints)
Full face photographic images
Any unique identifying number, characteristic code
Link to identifier (code)
If any of these items are checked off, the data cannot be considered de-identified and authorization from the
subject or a waiver of authorization (OHR-3) from the IRB is required.
*Use of these items alone falls under provisions of a “limited data set”, which requires the signing of a data use
agreement (OHR-6) by Principal Investigator. Please complete and attach, if applicable.
PLEASE NOTE: The following COI information and Signature pages should be completed if the OHR-15
represents a complete submission (i.e., your study involves ONLY collection and analysis of tissue). If your
study requires submission of other forms, do not complete the COI section on this form; complete the OHR1 including the COI information and signatures as well as other required forms.
CERTIFICATION OF CONFLICTS OF INTEREST (See TJU Policy 107.03, Conflicts of Interests for Employees”
attachment 2 for more detailed information)
THIS CERTIFICATION MUST BE COMPLETED AND ALL THE REQUIRED SIGNATURES MUST BE OBTAINED
BEFORE THIS PROTOCOL/RESEARCH PROJECT MAY BE ADMINISTRATIVELY PROCESSED.
Each Investigator and all Key Personnel must answer the following questions in relation to this
proposal. The TJU ID# requested can be found in the box on the left side of your pay stub. For nonJefferson employees, this section should be left blank.
Principal and Co-Investigators & Key Personnel:
Copy this section as necessary to accommodate all personnel on study.
Name:____________________________________________ TJU ID # ______________________
1. Do you or an immediate family member have any financial interests as defined in TJU Policy
107.03? [ ] Yes [ ] No
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2. Do you or an immediate family member have a significant financial interest that may pose a conflict
of interest as defined in the TJU Conflicts of Interest Policy 107.03?1 [ ] Yes [ ] No
If you checked “yes” to either question above, describe the financial interest below and any steps planned to
prevent the financial interest from interfering with the design, conduct, or reporting of the research, including
interfering with the protection of participants. Attach separate sheet if needed.
______________________________________________________________________________
______________________________________________________________________________
RELATIONSHIP(S) WITH OTHER ENTITIES
The Principal Investigator must complete the following:
Other than the entity paying for the study or as disclosed in the protocol, will any OTHER ENTITY(S):
1. Require and/or receive reports or other information regarding this study?
[ ] Yes [ ] No
If yes, list entity (s) ___________________
2. Be identified in any reports submitted to the FDA or other regulatory agencies?
[ ] Yes [ ] No
If yes, list entity(s) ____________________
3. Be given access to study data?
[ ] Yes [ ] No
If yes, list entity(s) ___________________________
4. Be given attribution in any publication or presentation regarding this study?
[ ] Yes [ ] No
If yes, list entity(s) __________________________
The IRB must be notified in writing by the PI should any of the answers to the above change.
1. If you are a TJU employee or faculty member, or a TJUH employee you must have submitted an up-to-date Disclosure of
Conflicts of Interest to University Counsel. If you have not, please complete an on-line Disclosure that can be accessed via the
Pulse homepage or a hard copy that may be obtained on the Office of University Counsel website. If you are not a TJU employee,
TJUH employee, nor a TJU faculty member, you must file a Disclosure Statement for Non TJU/TJUH Employees Conducting
Research indicating either the nature of the conflict of interest, if any, or certifying that you do not have a conflict of interest in a
financially interested company with regard to this proposal.
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SIGNATURES
I hereby request the Department of Pathology/TJUH provide me and/or my key personnel with human
tissues/specimens in accordance with the approval of the IRB (if applicable).
I recognize the risks and hazards to me and my key personnel in working with human tissues/specimens
that are potentially contaminated by infectious microorganisms (e.g., HIV, hepatitis, etc.). My key personnel
and I are familiar with Universal Precautions. (Contact the Institutional Biosafety Officer at 215-503-7422,
for more information about this.)
I understand that it is my responsibility that all tissues/specimens be handled and stored in accordance with
any and all State or Federal guidelines and regulations concerning handling, transport, and storage of
human tissues, blood and blood products.
I hereby accept any and all responsibility for pickup, transport, handling, and storage of all such tissues and
products derived from them. Furthermore, I understand that I may not give any such tissues/specimens
(including cells, products, DNA/RNA, etc.) to any other investigators not directly under my own supervision
on the above-named project, and that I may not sell these tissues/specimens.
I assure that the information I obtain as part of this research (including protected health information) will not
be reused or disclosed to any other person or entity other than those listed on this form, except as required
by law. If at any time I want to reuse this information for other purposes or disclose the information to other
individuals or entity, I will seek approval from the IRB.
Please print all names below signature lines. Copy as necessary.
__________________________
Principal Investigator
__________________________
Chairman
___________________________
Administrator
__________________________
Co-Investigator
__________________________
Chairman
___________________________
Administrator
__________________________
Co-Investigator
__________________________
Chairman
___________________________
Administrator
__________________________
Key Personnel
__________________________
Chairman
___________________________
Administrator
__________________________
Key Personnel
__________________________
Chairman
___________________________
Administrator
Dean, Jefferson School of Health Professions (for JSHP applications only)
________________________________________