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Thomas Jefferson University IRB
Genetic Research
(This form must be typed)
Federal guidelines require that investigators engaged in clinical genetic research address specific
issues regarding human genetic research. Genetic research is comprised of four stages:
(1) pedigree studies,
(2) positional cloning studies,
(3) DNA diagnostic studies,
(4) gene therapy research.
Unlike the risks presented by biomedical research, the primary risk of the first three types of research
are risk of social and psychological harm, rather than physical harm. Genetic studies that generate
information about subjects' personal health risks can provoke anxiety, confusion, damage to familial
relationships and compromise the subjects' insurability and employment opportunities. Please be
aware that different concerns may exist for each stage of genetic research and for tissue collected for
genetic research under a variety of circumstances.
PROJECT TITLE: _____________________________________________________________________
____________________________________________________________________________________
PRINCIPAL
INVESTIGATOR: _____________________________________________________________________
DEPARTMENT: _________________________________ DIVISION: ____________________________
TELEPHONE:___________________________________ FAX: ________________________________
EMAIL ADDRESS: ____________________________________________________________________
MAILING ADDRESS:___________________________________________________________________
____________________________________________________________________________
Please respond to the following concerns as they relate to your protocol. Attach responses
on a separate page if necessary.
1. Is your laboratory certified as a BL-2 facility:
Yes ______
No ______
IBC # _____
If No, contact the Biological Safety Officer at 215-503-7422 to arrange an inspection for
certification.
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2.
Does your protocol involve the use of tissue obtained from the Department of Pathology Tissue
Bank, or other discarded or stored human biological specimens (tissue, tumor, blood, CSF, etc.)?
Such samples may be in existence or may be available in the future but not collected specifically
for your research. If the latter, a Consent for Genetic Testing (OHR16A) is required.
 YES
»»»» If yes, complete a-g below; otherwise go to question 3 «««
 NO
a.) Description of samples requested:
b.) Request is for:




Discarded/stored samples which already exist
Discarded/stored samples to be obtained in the future (tissues to be banked or stored but
not for this research specifically)
Discarded/stored samples obtained during a clinically indicated procedure
Stored samples previously obtained for other research protocols
If they are stored research samples, was informed consent initially obtained?
 yes
 no
 do not know
If consent was obtained, what was the subject's understanding of what the samples
would be used for?
c.) Number of samples desired: _____
d.) Inclusive dates of sample collection period: _____
e.) Where will the samples be obtained? If discarded tissue needs to be taken directly from the
operating room or procedure room, please specify why it cannot be obtained from pathology:
f.) Will identifying information be recorded or links to identifiers maintained?
 yes
 no
If yes, what information will be maintained?
 name
 medical record number
 other (specify)
PLEASE NOTE: Informed consent must be obtained for any prospective or retrospective collection
of biological specimens that would normally be discarded if it were not going to be used for genetic
research purposes.
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When the research only involves the analysis of stored specimens or the use of completely deidentified specimens, a waiver of informed consent may be considered. If you are requesting a
waiver of consent, please respond to the following:
g.) Is the study minimal risk:  YES
 NO
Why is it not practical to conduct the research without an informed consent waiver?
Please address how waiving informed consent will not adversely affect the subject's rights or
welfare.
Specify how pertinent information will be provided to subjects, if appropriate, at a later date.
3. What stage is this genetic research:




4.
pedigree studies
positional cloning studies
DNA diagnostic studies
gene therapy research
What are your plans for disclosure of information, including interim or inconclusive research
results to the subjects?
5. What information are subjects entitled to receive at what point in the research? If information is
given to subjects, who will be responsible for disseminating the information?
6. What support is available to the subject after they receive the information (i.e. genetic
counseling)?
7.
If family members are to be studied, will family members be protected against disclosure of
medical or other personal information about themselves to other family members?
8. Will they be given the option to not receive information about themselves?
9. Is there the possibility that incidental findings may be made (i.e. paternity diseases or conditions
other than the one under study)? If so what will be done with this information?
10. Will the data be protected from third parties, such as employers and insurance companies? If
so, how will confidentiality be maintained?
11. Will research findings be disclosed to the subjects’ physicians) for clinical use? If so this needs
to be addressed in the consent form and with the subject.
12.
Are there psychological and or social risks associated with the research and the results
obtained? If so what are they and what steps will be taken to minimize or eliminate these risks?
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13.
If family members are included in the research, how will they be contacted? Are there
confidentiality issues (family members may not know an individual is sick or has a specific
condition)? Does the proposed strategy for recruiting subjects sufficiently protect prospective
subjects from the possibility of coercion or undue influence?
14. Will collected biological specimens (blood, tissue, DNA) be stored for future research, maintained
in a repository, or be used to establish a DNA bank? If so, please address:







Where will the tissue be stored? Specify the location within or outside of the institution.
What is the purpose of storing the tissue?
Will identifying information (or links to identifiers) be maintained with the tissue)?
Who will have control for distributing the tissue?
Would a subject be re-contacted and given information derived from the banked
specimens? If so, under what circumstances?
Are subjects able to withdraw tissue or ask that identifying information be removed?
Please describe what types of research you would anticipate using this specimen for in
the future.
15. Will research be conducted in states other than Pennsylvania (NA for commercially sponsored
multi-center trials)?
YES
NO
NA
If YES, what state(s)?
_______________________________
Provide information on any state-specific regulations regarding genetic research.
Informed consent requirements:
The informed consent must address the following issues as they relate to your protocol:









What information will be provided to subjects and when?
Can subjects chose not to receive results?
Will clinically relevant information be disseminated? If so, under what circumstances
and by whom?
What are the implications of the findings?
What support services are available, and what are the costs of support services?
What are the methods to insure confidentiality or can confidentiality not be promised?
What are the psychological and social risks including privacy, stigmatization of an
individual or a community/social group, confidentiality, insurability, employability?
Are there possibilities of incidental finding (i.e. non-paternity)? What happens to this
information?
Will tissue be stored for future research? Where? Identifiers? If so, who has access to
stored tissue? Does a subject have the ability to request to have sample removed from
storage?
CERTIFICATION OF CONFLICTS OF INTEREST
THIS CERTIFICATION MUST BE COMPLETED AND ALL THE REQUIRED SIGNATURES MUST BE
OBTAINED BEFORE THIS PROTOCOL/RESEARCH PROJECT MAY BE ADMINISTRATIVELY
PROCESSED.
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(Refer to the following definitions for answering the questions 1 and 2 below)
“Immediate Family” means spouse, dependent children, and all other persons living in the same
household, and any associated entity.
“Associated Entity” means any trust, organization or enterprise other than the University over which the
covered individual, alone or together with his / her immediate family, exercises a controlling interest.
“Financial Interest Related to the Research” means financial interest in the sponsor, product or service
being tested, or competitor of the sponsor or product or service being tested.
For Question 1 below, do you or your immediate family have any of the following?
 Ownership interest, stock options, or other financial interest related to the research unless it meets






four tests:
 Less than $10,000 when aggregated for the immediate family.
 Publicly traded on a stock exchange.
 Value will not be affected by the outcome of the research.
 Less than 5% interest in any one single entity when aggregated for the immediate family.
Compensation related to the research unless it meets two tests:
 Less than $10,000 in the past year when aggregated for the immediate family.
 Amount will not be affected by the outcome of the research.
Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright
or licensing agreement.
Board or executive relationship related to the research, regardless of compensation.
Consulting fees; honoraria; gifts or other financial compensation; or "in kind" compensation from a
financially interested company for any purpose not directly related to the reasonable cost of
conducting the research (as specified in the research agreement) or engaging in the activity; that when
aggregated for the covered individual and his/her immediate family in the prior calendar year
exceeded, or in the next calendar year are expected to exceed, $10,000.00.
Royalties, or inventor’s share of royalty income pursuant to the University’s Patent Policy, or the
right to receive future royalties or such inventor’s share under a patent license or copyright agreement
or any other type of agreement, where the research or activity is directly related to the licensed
technology or work.
Any non-royalty payments (or entitlements to payments) in connection with the research or activity
that are not directly related to the reasonable costs of the research (as specified in the research
agreement between the sponsor or company providing research funding and the University) or
activity. This includes any bonus or milestone payments to investigators in excess of reasonable costs
incurred, whether such payments are received from a financially interested company or from the
University.
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 non-Jefferson 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 # ______________________
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1.
Do you or an immediate family member have any of the above financial interests?
[
] Yes [
] No
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?
[ ] 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.
__________________________________________________________________________________________
__________________________________________________________________________________________
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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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.
Please print all names below signature lines.
_______________________
Principal Investigator
_______________________
Co-Investigator
____________________________
Chairman
____________________________
Chairman
_____________________________
Administrator
_____________________________
Administrator
_______________________
Co-Investigator
____________________________
Chairman
_____________________________
Administrator
_______________________
Key Personnel
____________________________
Chairman
_____________________________
Administrator
_______________________
Key Personnel
____________________________
Chairman
_____________________________
Administrator
Dean, Jefferson School of Health Professions (for JSHP applications only)
________________________________________