PROTOCOL NARRATIVE
University of California, Irvine
Human Stem Cell Research Oversight (hSCRO) Committee
Version: July 2011
hSCRO#:____________________
For Office of Research Use Only
Lead Researcher Name: <Type here>
Study Title: <Type here>
Important: Please read the instructions in the grey boxes before completing this protocol
narrative.
NON-TECHNICAL SUMMARY
Provide a non-technical summary of the proposed research project that can be understood by
hSCRO members with varied research backgrounds, non-scientists and community members.
The summary should include a brief statement of the purpose of the research and related
theory/data supporting the intent of the study and a brief description of the procedure(s). This
summary should not exceed more than ½ a page.
Notes:
 Avoid using scientific terminology, jargon or unexplained abbreviations; where use of such
language is unavoidable, provide definitions of all terms.
 Do not cut and paste from a grant application, journal article or abstract.
<Type here>
SECTION 1: PURPOSE AND BACKGROUND OF THE RESEARCH
1. Describe the purpose of the research project and state the overall objectives, specific
aims, hypotheses (or research question) and rationale for performing the study.
2. Provide the relevant background information on the aims/hypotheses (or research
question) to be tested and the procedures/products/techniques under investigation.
3. Include a description of the predictor and outcome variables, as appropriate.
4. Include a critical evaluation of existing knowledge, and specifically identify the
information gaps that the project intends to address.
5. Describe previous research that provides a basis for the proposed research. Include
references/citations, as applicable.
<Type here>
SECTION 2: ROLES AND EXPERTISE OF THE STUDY TEAM
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1.
2.
List all study team members below and include a description of their specific role and
responsibility for the proposed research.
Describe each study team members’ expertise or training in derivation or culture of
human stem cells.
Lead Researcher:
<Type here>
Co-Researcher(s):
<Type here>
Research Personnel:
<Type here>
SECTION 3: CELL LINE USE AND TRACKING
Complete the below table for each cell line to be used during this research protocol. Insert
additional rows if necessary.
Material
Source
Quantity
Feeder Material
Registry # OR
Specific
Identification #
UCI MTA#
Registered Line*
(NIH, CIRM, etc.)
Non-Registered Line
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.
SECTION 4: RESEARCH METHODOLOGY/ STUDY PROCEDURES
Provide a concise description of the experimental design below, describing all experiments to
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be performed. Briefly describe the rationale behind the experiment or the hypothesis being
tested (i.e., the reason for performing the procedure). Please include tables and charts where
applicable.
Notes:
1. Do not cut and paste from a grant application, journal article or abstract.
2. Provide a detailed chronological description of all study procedures.
3. When applicable, provide information about the measures and outcome variables and the
statistical methods of analysis.
<Type here>
SECTION 5: STORAGE AND PROCESSING OF STEM CELLS
1.
2.
3.
4.
Describe the process for characterizing the cells.
Describe the process for expanding, maintaining, and storing the cells.
Outline the system for quality assurance and control of the cells.
If the cells will be banked:
a. If the cells will be banked and/or distributed to other investigators, please
provide detailed information for the existing bank or other investigators.
<Type here>
SECTION 6: CONFIDENTIALITY OF RESEARCH DATA
1. Explain how data will be collected and recorded.
Data Collection/Method of Recording (check all that apply):
[
[
[
[
[
[
[
] Paper documents/records
] Computer files/database
] Audio recording
] Video recording
] Photographs
] Biological specimens
] Other(s) (specify): <Type here>
2. Indicate how data will be stored, secured including paper records, electronic files,
audio/video tapes, etc.
Electronic Data (check all that apply):
[ ] Anonymous or de-identified data only (i.e., no code key or key destroyed)
[ ] Coded data with the code key kept in separate location
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[
[
[
[
] Encryption or password protection software will be used
] Secure network server will store data
] Stand alone desktop computer will house data (not connected to server/internet)
] Other (specify here): <Type here>
Hardcopy Data, Recordings and Specimens (check all that apply):
[ ] Anonymous or de-identified only (i.e., no code key or key destroyed)
[ ] Locked file cabinet or locked room at UCI/UCIMC will house data
[ ] Locked lab/refrigerator/freezer at UCI/UCIMC will be used to store data
[ ] Other (specify here): <Type here>
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