/ Human Stem Cell Research Oversight (hSCRO)
New Application for hSCRO Review
Version Jan 2018
Submit thisapplication and any supplemental documentation to the hSCRO Administrator () / hSCRO USE ONLY –
hSCRO#:

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. Studies that include in vivo transplantation of human neural stem/progenitor cells into the brain of a non-human animal at any state of embryonic, fetal, or postnatal development will also have to be reviewed by hSCRO and IACUC (concurrent review) before they proceed.Human stem cell activities that qualify as “human subject research” will require both IRB and hSCRO review and approval. hSCRO Committee review is concurrent with IRB application review.

For more information, check the link

All New research protocol submissions must be reviewed by the hSCRO Full Committee.

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>
PRINCIPAL INVESTIGATOR EMAIL: <Type here>
STUDY TITLE: <Type here>

SECTION 2: STUDY TEAM MEMBERS

All individuals who will perform research procedures that includes the use of cells/materials listed on the protocol, interact or intervene with human subjects or will have access to identifiable private information about human subjects for this protocol must be listed here and in the Protocol Narrative. Insert additional rows for Co-Researcher and Research Personnel when necessary.
Lead Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
UCI net ID:<Type here>
Co-Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
UCI net ID:<Type here>
Research Personnel:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
UCI net ID:<Type here>
Research Personnel:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
UCI net ID:<Type here>

SECTION 3: STUDY FUNDING

Indicate how the study costs will be supported.
Grant/Sub-award (provide details below)
Contract/Subcontract (provide details below)
Department or campus funds (includes department support, unrestricted funds, start-up funds, etc.)
Non-cash support from manufacturer/sponsor (e.g., free drug, device, research materials)
List all extramural proposals or awards that will support this study:
Agency/Sponsor: <Type here>
Title of Proposal/Award: <Type here>
Award #: <Type here>
PI of Award: <Type here>

SECTION 4: OTHER UCI COMMITTEE REVIEWS

Indicate all applicable committee reviews that are required for this research.
Institutional Review Board (IRB)
Institutional Animal Care and Use Committee (IACUC)
Protocol Review and Monitoring Committee (PRMC)
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) before beginning research procedures.

SECTION 5: LOCATION, STORAGE, AND PROCESSING OF STEM CELLS

Complete the below table describing the location, storage, and processing of the proposed stem cells. Add rows if necessary.
If you wish to maintain the cells after the completion of the research, please explain how and where the cells will be maintained.
Cell Information / Location (Building AND Room) / Research, Storage OR Both
Ex: H9 / Gross Hall 1201 / Both
Maintenance of cells:
<Type here>

SECTION 6: 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

SECTION 8: 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 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

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