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Thomas Jefferson University IRB
Tissue and Genetic Research
This form must be completed for any study involving only tissue and genetic research. If you
intend to seek consent from human subjects, do not use this form. Please return this form to
the Division of Human Subjects Protection.
PLEASE NOTE: The COI information and Signature pages should be completed if the OHR-16
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 OHR-1 including the COI information and signatures as well as other
required forms.
Form must be typed.
Project Title: ______________________________________________________________
_________________________________________________________________________
Principal Investigator:
Department:____________________________________________Division:____________
Contact Person: __________________________________
Email address:________________________________ Phone/Extension:______________
CCRRC APPROVAL
[
] If the scope of your research involves human subjects and cancer, please certify that the protocol
has been approved by the CCRRC (Clinical Cancer Research Review Committee) by attaching a
copy of the CCRRC approval letter. YOU MAY NOT SUBMIT TO THE IRB UNTIL YOU HAVE
CCRRC APPROVAL. Contact the CRMO at 955-0017 for more information.
.
Note: For all NEW studies a completed OHR-1 must also be included with your
submission.
1. Is your laboratory certified as a BL-2 facility:
Yes ______
No ______
IBC # _____
2. If No, contact the Biological Safety Officer at 215-503-7422 to arrange an
inspection for certification.
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.”
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.
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______ Has established the right to be a co-author on any publications related to this
protocol
______ Certifies that Jefferson ORA is negotiating a sponsored research agreement, to
be signed prior to work commencing.
4. What is the nature of the research:
[
[
[
] Pedigree studies (tracking genetic traits in families)
] Positional cloning studies (determining the location of a gene of interest)
] DNA diagnostic studies (identification of heritable conditions/diseaseassociated genes)
[ ] Pharmacogenomics/genetics (genes related to drug metabolism)
[ ] Study of genes related to disease processes (genes related to inflammation
mediators, intra and inter cellular communication, etc.
[ ] Gene therapy or gene transfer research
5. Will results of tests be given to subjects? [
] YES [
6. Are subject’s family members going to be studied? [
] NO
] YES [
7. Will results of tests be given to subject’s family members? [
] NO
] YES [
] NO
If YES to question 5 or 6, please explain your plans for disclosure of information.
8. Will subjects or family members be given the option to not receive information about
themselves? [ ] YES [ ] NO
If NO, how will information be disclosed to them?
9. How will confidentiality and privacy be protected?
10. If there is the possibility that incidental findings may be made (i.e. paternity, diseases or
conditions other than the one under study), explain your plan for disclosure to subject.
[ ] YES [ ] NO
11. What support services are available to the subject/family member after s/he receives
information (i.e. genetic counseling)?
12. Will research findings be disclosed to the subjects’ physicians for clinical use?
[ ] YES [ ] NO
13. Are there psychological and or social risks associated with the research and the results
obtained? [ ] YES [ ] NO
If YES, what are they and what steps will be taken to minimize or eliminate these risks?
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TISSUE STORAGE FOR FUTURE RESEARCH
1. Will collected biological specimens be stored for future research, maintained in a
repository, or be used to establish a DNA bank? [ ] YES [ ] NO
If YES, please address the following:
Where will the tissue be stored? Specify the location within or outside of Jefferson.
What is the purpose of storing the tissue?
Will identifying information (or links to identifiers) be maintained with the tissue?
[ ] YES [ ] NO (If YES complete an OHR-3).
Who will have control for distributing the tissue?
Would a subject be re-contacted and given information derived from the banked
specimens? [ ] YES [ ] NO
If YES, under what circumstances?
Would a subject be re-contacted and asked for additional information related to his/her
disease or condition? [ ] YES [ ] NO
If YES, under what circumstances? (NOTE – may require submission of a new
project for IRB review and approval)
Are subjects able to withdraw tissue or ask that identifying information be removed?
[ ] YES [ ] NO
2. Please describe what types of research you would anticipate using this specimen for in
the future.