Human Stem Cell Research Oversight (hSCRO)
Continuing Protocol Review
Version 2016
Submit this application and any supplemental documentation to the
hSCRO Administrator (OR-hSCRO@exchange.uci.edu)
hSCRO USE ONLY –
hSCRO#:
SECTION 1: INVESTIGATOR AND STUDY INFORMATION
Provide the below information for the Principal Investigator and study information
PRINCIPAL INVESTIGATOR: <Type here>
DEPARTMENT OR RESEARCH UNIT: <Type here>
STUDY TITLE: <Type here>
FUNDING SOURCE: <Type here>
SECTION 2: STATUS OF PROTOCL AT CONTINUING REVIEW
Check all boxes that represent the current status of the study. Do NOT check boxes that do not apply to
the study.
Existing Human Tissue and Stem Cell Lines
Use of existing human tissue and/or stem cell lines has not yet begun
Use of existing human tissue and/or stem cell lines is ongoing
Use of existing human tissue and/or stem cell lines is complete
Derivation and Creation of New Stem Cell lines
Derivation of new human stem cell lines has not yet begun
Derivation of new human stem cell lines is ongoing
Derivation of new human stem cell lines is complete
Collection of Human Gametes, Embryos
Collection of gametes and/or embryos has not yet begun
Collection of gametes and/or embryos is ongoing
Collection of gametes and/or embryos is complete
Collection or Experimental Use of Embryonic or Fetal Tissue
Collection of embryonic or fetal tissue has not yet begun
Collection of embryonic or fetal tissue is ongoing
Collection of embryonic or fetal tissue is complete
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SECTION 3: PROGRESS REPORT
Provide a description of the progress of the study (this summary should not exceed more than ½ a
page).
 Include a discussion about the number of cell lines/gametes/embryos used and the number of
the cell lines derived, as applicable.
 Provide information about how the materials were used during the last year; discuss activities
involving animals, anticipated or unanticipated cell functions and any unanticipated differentiation
patterns.
 Include a brief summary of any interim findings or trends, and specific plans for the next approval
period.
 NOTE: UPDATE YOUR CELL TRACKING TABLE APPENDIX WITH NEW AND REMOVED
CELL LINES, AND NEW VALUES.
<Type here>
Publications and Presentations: Provide citations for any publications or presentations resulting from this
study since the last hSCRO review. If no publications/presentations resulted indicate “none”.
<Type here>
SECTION 4: LEAD RESEARCHER CERTIFICATION STATEMENT
I certify that the information contained herein is true and accurate to the best of my knowledge. I confirm
this application for continuing review accurately reflects the current research activities associated with
this protocol. I understand that if any changes need to be made, I should obtain approval for the
change(s) via modification request prior to seeking continuing review or hold proposed changes until
after continuing approval has been granted.
______________________________
Signature of Lead Researcher
_________
Date
______________________________
Signature of Lead Researcher
(if a Faculty Sponsor is required)
_________
Date
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SECTION 5: 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
Vice Chancellor for Research signs on behalf of the EVC)].
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.
By signing below, I hereby confirm that I have read this Continuing Protocol Application 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 Researcher (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.
______________________________
Signature of Department Chair/ORU Director
__________
Date
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