Embryonic Stem Cell Research Oversight Committee (ESCRO-C)
HUMAN EMBRYONIC STEM CELLS RESEARCH
SUBMISSION INFORMATION
The University of Nebraska has stated that all Human Embryonic Stem Cell (hESC) research,
regardless of funding, is subject to the Presidential Executive Order limitations and that both the
UNMC Embryonic Stem Cell Research Oversight Committee (ESCRO-C) and Institutional Review
Board (IRB) must provide regulatory oversight of all hESC research conducted at UNMC, The
Nebraska Medical Center, or UNO.
SUBMISSION DEADLINE
Protocols can be submitted on any business day. Incomplete submissions may, however, result in
delay of ESCRO and IRB review.
SUBMISSION DOCUMENTS
Submit one original and one copy of this ESCRO Application and any necessary Addendum as
specified in Section II.
CLASSIFICATION OF RESEARCH PERSONNEL
All research personnel must possess the necessary experience, skill and professional licensure. All
personnel listed in any of these categories are required to complete human subject protection training
through the Collaborative IRB Training Initiative (CITI) program (http://www.citiprogram.org). The
ESCRO Committee and IRB cannot approve new protocols, or re-approve existing protocols, until all
listed personnel have been trained.
Personnel should be classified as one of the following:
1.
Principal Investigator (PI)
This individual assumes overall responsibility for 1) development and submission of the
Application to the ESCRO, 2) the conduct of the research in full compliance with the protocol,
ESCRO and IRB requirements, all applicable regulations, and state law and 3) publication of the
data. Only one PI can be named on the ESCRO application.
2.
Secondary Investigator(s) (SI)
These individuals share responsibility with the PI for 1) development and submission of the
Application to the ESCRO, 2) the conduct of the research in full compliance with the protocol,
ESCRO and IRB requirements, all applicable regulations, and state law and 3) the publication of
the data.
3.
Participating Personnel
These individuals are not normally involved in the development and submission of the Application
to the ESCRO but will be participating in conducting the laboratory procedures.
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Embryonic Stem Cell Research Oversight (ESCRO) Committee
HUMAN EMBRYONIC STEM CELL RESEARCH
SECTION I
1. STATUS
New Submission
Revised protocol, ES#
; Version # or date
Application submitted with Continuing Review, ES #
; Version # or date
2. TITLE OF PROTOCOL:
3.
RESPONSIBLE PERSONNEL: In order to verify CITI training, please list each individual’s full
name (i.e., first, middle and last) and degree. For UNMC/UNO personnel, the name should
match the full legal name utilized by the University of Nebraska. Please do not use nicknames.
A. Principal Investigator (PI)
Name:
Department:
Address:
Email address:
Phone:
Academic Position:
Campus Zip:
Pager:
B. Secondary Investigator (SI)
Name
Academic Position
Department
Academic Position
Department
C. Participating Personnel
Name
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4. FUNDING SOURCE: Check all that apply and provide the source of funding.
Note: All research must have a source of funding. Examples of other funding may be
departmental funds or personal funding.
Grant – Provide source:
Commercial – Provide company name:
Other – Provide source:
5.
Are the funds stated above eligible for hESC research? Note: For example, State of
Nebraska Tobacco Settlement or LB606 funds may not be used for hESC research.
Yes
No
6. FUNDING AGENCY DEADLINE FOR IRB APPROVAL:
7. CONTRACT: Is there a contract or agreement associated with this study?
Yes
No
8. STUDY SITES:
A. Provide the names and locations of all study sites where this research will be
conducted under the oversight of the UNMC IRB. Note: Study sites are defined as all internal
or external locations, such as a clinic, laboratory, school, center where UNMC, UNO, and The
Nebraska Medical Center (NMC) investigators or staff interact with subjects, collect data or solicit
consent (e.g., UNMC, NMC, Turner Park Clinic, Monroe Meyer Institute, individual physician
offices, Village Pointe Cancer Center, Millard North High School.)
B. Provide the names and locations of all study sites where UNMC, The Nebraska Medical
Center, or UNO is the lead site for a multi-institutional protocol and either data is collected
and analyzed at UNMC or adverse events are tracked at UNMC. Note: This section should
specify study sites at institutions that are under the oversight of external IRBs (e.g., Omaha VA
Medical Center, other academic health science centers or hospitals, other universities).
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9.
CERTIFICATION OF PRINCIPAL INVESTIGATOR
The Principal Investigator understands and accepts the following obligations:
I recognize that as the Principal Investigator it is my responsibility to ensure that this research and the
actions of all project personnel involved in conducting the study will conform with the protocol approved
by the ESCRO Committee and the IRB.
I will ensure that all project personnel are trained properly and are fully aware of their responsibilities
according to the ESCRO and IRB policies and procedures.
I will not initiate any change in protocol without ESCRO Committee and IRB approval.
All listed study personnel have completed the IRB required CITI Training.
I will maintain all required research records on file; and I recognize that the ESCRO Committee and the IRB
is authorized to inspect these records.
I certify that there are adequate recourses and facilities to carry out this research, including staff, funding,
space, and record keeping capability.
I understand that continuing review of the protocol by the ESCRO Committee and IRB is required at
least annually for studies which are not exempt.
I will inform the IRB immediately if I become aware of any violations of ESCRO and/or IRB requirements.
I understand that failure to comply will all ESCRO and IRB requirements/policies and the provisions of
the protocol as approved by the IRB may result in suspension or termination of my research project.
____________________________________________________________________________________________________________________________
Printed Name of Principal Investigator
_________________________________
Signature of Principal Investigator
__________
Date
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10. SCIENTIFIC/SCHOLARLY MERIT AND RESOURCE REVIEW CERTIFICATION
Note: Research proposals must undergo substantive scientific and scholarly merit and resource
review prior to submission of the application to the ESCRO. This ESCRO Application must provide
evidence of this review.
The chairperson, authorized delegate, or appointed review committee of the principal investigator’s
school, department or division is responsible for review of the research proposal prior to submission
to the IRB. A Chairperson who is also a PI cannot provide certification.
The following attestation statement must be signed:
My signature certifies that this application has been reviewed for scientific/scholarly merit and
available resources. I have determined that the rights and welfare of human subjects involved in this
research will be fully protected based upon the following:
1)
The proposal has a sound research design which will achieve the stated objectives,
2)
The Principal Investigator has the necessary qualifications, experience, and hospital
credentials.
3)
The Principal Investigator has or will have the necessary funding before initiation of this
research.
4)
The Principal Investigator has access to the physical space required for the research
interventions, adequate laboratory and clerical support, data storage capability, and any
other resources necessary to complete this study.
5)
The Principal Investigator has access to emergency equipment, personnel, or services
necessary to respond promptly to adverse events or unanticipated problems involving risk to
the subject or others.
If the necessary resources become unavailable I will notify the ESCRO Committee and IRB.
________________________________________________________________________________________________________________________
Printed Name of Reviewer
____________________________________________________________________________________________________________________________________________________ _
Position
______________________________ __________
Signature of Reviewer
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Date
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SECTION II
Instructions: Each subpart must be titled using boldface subheadings as described below and
addressed independently in the listed sequence without reliance on information covered under other
subparts. Attachment of applicable sections of the grant application is not acceptable as a substitute
for completion of each subpart. Please include sufficient information to facilitate an effective review
by all members of the ESCRO and IRB including non-specialists.
1. PROTOCOL ABSTRACT (SCIENTIFIC TERMINOLOGY)
Provide a brief (less than 400 words) abstract of the research protocol. This summary
should include the title of the protocol, and a brief description of the purpose of the study,
the cell lines to be used, and proposed evaluations of the material.
2. PROTOCOL ABSTRACT (LAY TERMINOLOGY)
Provide an abstract of the research written in lay terms that will be provided to the
University Chancellor. Note: This could possibly be made public in the future.
3. PURPOSE OF THE STUDY
What are the specific scientific objectives (aims) of the research?
4. BACKGROUND AND RATIONALE
Describe the background of the study. Include a critical evaluation of existing knowledge,
and specifically identify the information gaps that the project is intended to fill. Note: This
section should clearly support the purpose and potential benefit of the study and must contain
appropriate literature citations.
5. CELL LINES
A. Please provide the requested information regarding the source of the cell lines:
[see http://stemcells.nih.gov/research/registry/ for information]
Vendor
NIH Registry & Vendor Number
Number of lines
1.
2.
3.
4.
5.
B.
What is the rationale for using hESC line(s) to perform the research? Note: This section
should clearly state what the alternatives are to using hESC line(s).
C.
What is the rationale for the use of the chosen hESC line(s) over another NIH
approved hESC line(s)?
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6. LABORATORY PROCEDURES
Describe briefly the tests which will be performed using the hESC lines.
7. DISPOSITION OF REMAINING CELL LINES AT END OF THE STUDY
Do you anticipate there will be cell lines that have not been used at the end of the study?
No.
Yes. Describe the disposition of the cell lines.
8.
After completion of this research, will any un-used cell lines be stored for future research?
(Note: A new MTA may be required)
No.
Yes. Respond to the following questions:
A. Where will the cell lines be stored and how will they be secured?
B. Who will have access to the cell lines? (Note: The MTA for the study must allow for
the storage of the cell lines after the research is complete.)
9. POTENTIAL BENEFITS TO SOCIETY
What is the value to society (e.g., advancement of knowledge) that may result from this
research?
10. ANIMAL RESEARCH
Note: Prospective IACUC approval is required when using covered animal subjects in hESC research
Will the research include work with animals?
No,
Yes. Please provide the IACUC # or indicate whether an application will be submitted.
11. IBC RESEARCH
Note: Prospective IBC approval is required when using biohazardous agents in hESC research.
Will the research include work with biohardous agents?
No
Yes. Please provide the IBC# or indicate whether an application will be submitted.
12. REFERENCES
List the references cited in Section II.4 (background and rationale).
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