APPLICATION FOR HSCRO REVIEW
Human Stem Cell Research Oversight (hSCRO) Committee
University of California, Irvine
Version: May 2012
All research or clinical investigations that involve the use of pluripotent human stem cells shall be reviewed and
approved by the UCI hSCRO before such activities are initiated by or for UCI. This review requirement applies
to the use of human gametes and embryos (e.g., blastocysts), the derivation and/or use of human embryonic
(hESCs) or fetal stem cells, induced pluripotent stem cells (iPS) derived from adult cells, any cells which can
differentiate into a gamete, and any other human pluripotent stem cells.
It is not necessary to obtain hSCRO approval for adult tissue specific stem cells such as hematopoietic cells or
mesenchymal cells unless such cells have been shown to, or are being induced to differentiate into the three
major germ lines.
Human stem cell activities that qualify as “human subject research” will require both IRB and hSCRO review
and approval. hSCRO Committee approval must be obtained prior to IRB application review and approval.
PRINCIPAL INVESTIGATOR:
DEPARTMENT OR RESEARCH UNIT:
EMAIL:
TITLE OF THE STUDY:
A. LEVEL OF REVIEW
Please select the required level of hSCRO review for this protocol.
Expedited Review – Please select the applicable expedited category
Category 1: Purely in vitro uses of NIH registered, CIRM registered, and UK Stem Cell
Bank human stem cell lines.
Category 2: Purely in vitro uses of acceptably derived stem cell lines when the UCI
hSCRO has on record documentation of the provenance of the cell lines.
Full Committee Review – If this protocol does not fall into one of the above expedited categories please
select Full Committee Review.
B. STUDY TEAM MEMBERS
UCI hSCRO Committee
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All individuals engaged in research on this protocol must be listed here and in the Protocol Narrative.
1. Lead Researcher:
Name:
Email:
Phone:
Department:
2. Co-Researcher Names (if applicable):
3. Other Research Personnel (if applicable):
4. Administrative Contact(s) (optional)
Name:
Email:
Phone:
C. STUDY FUNDING
Indicate how the study costs will be supported.
Grant/Subaward (provide details below)
Contract/Subcontract (provide details below)
Department or campus funds (includes department support, unrestricted funds, start-up funds, personal
funds, campus program awards, etc.)
Non-cash support from manufacturer/sponsor (e.g., free drug, device, research materials)
Subject/subject’s insurance/third party payer
Student project that will incur no costs
List all extramural proposals or awards that will support this study:
Agency/Sponsor:
Title of Proposal/Award:
Award #:
SPA Proposal #:
PI of Award:
UCI hSCRO Committee
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If more than one proposal or award will support this study please copy and paste the table above.
D. OTHER UCI COMMITTEE REVIEWS
Please check all applicable committee reviews that are required for this research. NOTE: If this research
requires IRB review and approval, hSCRO review and approval must be obtained before IRB review and
approval.
Institutional Review Board (IRB)
Institutional Animal Care and Use Committee (IACUC)
Clinical Trials Protocol Review and Monitoring Committee (CTPRMC)
Clinical Research Finance Assessment (CRFA)
Conflict of Interest Oversight Committee (COIOC)
Radiation Safety Committee Review (RSC)
Radioactive Drug Research Committee (RDRC)
All research involving the use of human stem cells must be reviewed and approved by the Institutional
Biosafety Committee (IBC).
E. ACTIVITIES INVOLVING STEM CELLS & STEM CELL LINE TRACKING
Please specify the activities to be performed for this research. Please complete the tracking table for each
cell line to be used.
1. Activities involving stem cells: (choose all that apply)
Use of existing human embryonic stem cell lines
Use of existing human induced pluripotent stem (iPS) cell line
Use of human adult pluripotent stem cells
Introduction of human stem cells into nonhuman animals
Generation of human stem cell lines
Derivation of human gametes
Parthenogenesis or androgenesis to generate human embryo-like entities
Human somatic cell nuclear transfer (SCNT) into enucleated human oocytes
Human somatic cell nuclear transfer (SCNT) into enucleated non-human oocytes
Human embryonic stem cell research without the creation of new stem cell lines
2. Cell information:
Material
Source
Quantity
Feeder Material
Registry # OR
Specific
Identification #
UCI MTA#
Registered Line*
NON-Registered Line
UCI hSCRO Committee
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Embryo
Oocyte
Somatic Cells (Please
list type):
Fetal Tissue
Cord Blood
Other: (Please indicate
below)
* Please note: If the line to be used is listed on the NIH Registry, the UK Stem Cell Bank, or the CIRM Registry provenance
documents are not required.
F. LOCATION, STORAGE, AND PROCESSING OF STEM CELLS
Please complete the below table describing the location, storage, and processing of the proposed
stem cells.
If you wish to maintain the cells after the completion of the research, please explain how and where the
cells will be maintained.
a. If the cells will be banked or distributed to other investigators, please provide detailed
information for the existing bank or other investigators.
Cell Information
Ex: H9
Location (Building AND Room)
Gross Hall 1201
Research, Storage OR Both
Both
Maintenance of cells:
G. ANIMAL USE
Please complete the below table if this research involves the use of animals.
Animal
Ex: mice
Number of Animals
10
Associated Approved IACUC #
XXXX-XXXX
NOTE: California regulations and NAS Guidelines indicate, No animal into which hPSC have been
introduced at any stage of development should be allowed to breed.
UCI hSCRO Committee
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H. DEPARTMENTAL OR ORGANIZED RESEARCH UNIT (ORU) APPROVAL
The Department Chair’s signature is required if the study will be performed under the auspices of a
Department (includes campus centers and school-based research units). If the Department Chair is a
member of the research team on this application (including Faculty Sponsor), approval must be obtained
from the next highest level of administrative authority (i.e., School Dean, Executive Vice Chancellor).
The ORU Director’s signature is required if the study will be performed under the auspices of an ORU. If the
ORU Director is a member of the research team on this application (including Faculty Sponsor), approval
must be obtained from the Vice Chancellor for Research.
Department or ORU Assurance Statement:
By signing below, I hereby confirm that I have read the Application for hSCRO Review and hSCRO Protocol
Narrative or IRB Protocol Narrative and I certify that:
1. The research is appropriate in design (i.e., the research uses procedures consistent with sound
research design, the study design can be reasonably expected to answer the proposed question,
and the importance of the knowledge expected to result from the research is known).
2. The Lead Research (and Faculty Sponsor) is competent to perform (or supervise) the study.
3. All study team members have disclosed to the COIOC any personal financial interests in the
research.
4. There are adequate resources and funds available to support performance of this research,
including costs associated with subject injury if applicable.
______________________________________________________________________________________
Typed Name of
Signature of
Date signed
UCI Department Chair/ORU Director
UCI Department Chair/ORU Director
I. LEAD RESEARCH CERTIFICATION STATEMENT
I certify that the information contained herein is true and accurate to the best of my knowledge. I confirm this
application for hSCRO review accurately reflects the proposed research activities associated with this
protocol. All named individuals on this project have read and understand the procedures outlined in the
protocol. I understand that if any changes need to be made, I should obtain approval for the change(s) via a
formal modification request prior to approval has been granted.
__________________________________
Signature of Lead Researcher
______________________
Date
__________________________________
Signature of Faculty Sponsor (if applicable)
______________________
Date
UCI hSCRO Committee
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UCI hSCRO Committee
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