FOR HSCRO USE ONLY
Protocol #:
Expiration Date:
Please complete the application and send a copy to: hscro@case.edu
For questions regarding this Human Stem Cell Research Oversight form please contact:
JC Scharf-Deering
Phone: 216.368.4513
Email: jcs12@case.edu
HUMAN STEM CELL RESEARCH APPLICATION
INSTRUCTIONS: Please carefully review and complete all applicable sections of this application. Some sections
of the application may not apply to your project.
Please remember to include all requested attachments. A checklist appears at the close of the application to
assist with this process.
Please be aware that the Case Western Reserve University Human Stem Cell Research Oversight Committee
(HSCRO) works closely with review boards and bodies across campus and with affiliated institutions. Depending
on the nature of your proposal, your work may require prior review and approval by additional committee(s) before
your project can be initiated.
Additional review and approval may be required by the appropriate Institutional Review Board (IRB), Institutional
Animal Care and Use Committee (IACUC), and/or Institutional Biosafety Committee (IBC).
NO RESEARCH WILL BE REVIEWED OR CONSIDERED THAT FALLS UNDER THE FOLLOWING
DESCRIPTIONS:
Prohibited Activities- Constitute activities that are not permitted at this time according to international and
national stem cell research professional guidelines and local laws. Prohibited activities include, but are not limited
to, in vitro cultivation for research of a human embryo beyond 14 consecutive days of development, the breeding
of laboratory animals that may potentially carry human sex cells in their gonads, and the transfer into a human or
non-human primate uterus a preimplantation embryo of any species containing any transferred human pluripotent
stem cells.
SECTION-1: PERSONNEL INFORMATION
Principal Investigator’s (PI) Name:
Primary Institution:
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Primary Department (s):
Secondary Department (s):
Contact Information:
Telephone:
Email:
Laboratory Location(s):
Biosafety Level/Animal Biosafety Level of Laboratory:
Funding Source (please list all applicable funding):
If Federal funds support this project, please include the portion of the grant application that supports this research
along with your submission.
List of all key personnel, including role/title on the project and their contact information:
SECTION-2: DEFINITIONS OF HUMAN STEM CELL TYPES
Pluripotent stem cells: Cells that have the capacity to (1) make identical copies of themselves (i.e. self-renew) and
(2) form more specialized cells representing each of the three germ layers: the ectoderm (e.g. skin, brain); the
endoderm (e.g. gut, lungs); the mesoderm (e.g. blood and bone), and the germ line (sperm and eggs).
Unipotent stem cells: Cells that can self-renew and form specialized cells representing the germ line or just one of
the three germ layers.
SECTION-3: PROJECT DESCRIPTION AND SCIENTIFIC MERIT
Complete Project Title:
Brief Project Description: In 2 or 3 paragraphs, please describe the proposed research using layman’s terms:
Scientific Project Description: Please attach a complete description of the project. The project description should
include the minimum elements of a research protocol, including a statement of objectives, hypothesis,
experimental design, procedures, and references.
Scientific Merit Review:
Has an independent scientific merit review been conducted?
YES/NO:
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SECTION-4: REVIEW CATEGORIES
Please review and respond to the following. Select all that apply. You may select “YES” to more than one option.
4A. In vitro only research with established cell lines:
Does your research use only established human pluripotent stem cell lines from the National Institutes of Health
Human Pluripotent Stem Cell Registry for in vitro research? http://grants.nih.gov/stem_cells/registry/current.htm
YES/NO:
4B. In vitro only research with derived cell lines from stored human tissues:
Does your proposed research seek to derive human induced pluripotent stem cells (hiPS) from stored human
tissues for in vitro research? The HSCRO office will work congruently with the IRB office(s) to provide adequate
informed consent disclosures for hiPS cell derivation.
YES/NO:
If YES, you must also complete Section 6 of this application.
4C. Establishment of new cell lines from prospective collection of human tissues:
Does your research involve prospective collection of tissues for derivation of new (not established or already
existing) human pluripotent and induced pluripotent stem (hiPS) cell lines?
YES/NO:
If YES, you must also complete Section 6 of this application.
4D. Transfer of human pluripotent stem cells and/or derivative into animals:
Does your research involve the transfer of human unipotent or pluripotent stem cells, (hiPS) cells, and/or any of
these stem cell types’ direct derivatives into laboratory animals only where there is a possibility of human cell
integration into the animals' central nervous system (CNS) and/or the animals' sex cells?
YES/NO:
If YES, please be sure to review and complete SECTION-8 of this application.
If YES, will the research involve injection of cells or their direct derivatives into animals at any stage of
development, other than standard teratoma assays in adult mice?
YES/NO:
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If YES, explain the likelihood of human stem cell contribution and/or integration into animal central nervous
systems and/or germ lines:
SECTION-5: SPECIFIC CELL LINES AND TYPES USED IN RESEARCH PROJECT
Please indicate the cell type (check all that apply). As applicable, provide any additional details (e.g. method of
vectors for hiPS production, cell line identifier(s), source, and contact information).
5A. Fully differentiated human somatic cells (for creation of human Induced Pluripotent Stem (hiPS)
cells):
5B. Human-Unipotent stem cells and their direct derivatives:
5C. Human-Pluripotent stem cells and their direct derivatives:
SECTION-6: SOURCE OF CELLS
Please indicate all that apply.
Will cells (or tissue) be sourced directly from human subjects by the PI or his/her team member?
YES/NO:
If NO, please explain the following: How were the cells obtained (purchased/sent to the PI/collaboration/provided
by a core facility)? Please include any attachments, including applicable Material Transfer Agreement.
If YES, please provide IRB-protocol information:
Is the IRB project approved?
YES/NO:
If YES, please provide the following:
Name of IRB where review request was submitted:
IRB protocol number:
PI of the IRB protocol:
Approval Date:
Expiration Date:
Please attach a copy of the IRB approval letter.
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Please attach a copy of approved consent form.
If NO, please provide the following:
Name of IRB where review request was submitted:
IRB protocol number:
PI of the IRB protocol:
Please attach a copy of the consent form.
The HSCRO maintains a library of resources for the development of informed consent document language related
to human stem cell research. Please visit the CWRU HSCRO website
(https://research.case.edu/Compliance/HSCRO.cfm) to access this information.
SECTION-7: DERIVATION OF hiPS CELLS
Does your project involve the derivation of hiPS cells?
YES/NO:
If YES, will you use recombinant DNA (rDNA), pathogenic or other infectious agents and/or recombinant viral
vectors to create the hiPS cells?
YES/NO:
If NO, please explain how cells will be derived:
If YES, please provide the following:
Is the IBC project approved?
YES/NO:
If YES, please provide the following:
Name of IBC where review request was submitted:
IBC protocol number:
PI of the IBC protocol:
Approval Date:
Expiration Date:
Please attach a copy of the IBC approval letter.
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If NO, please provide the following:
Name of IBC where review request was submitted:
IBC protocol number:
PI of the IBC protocol:
Need information or need to submit your request to your IBC?
Cleveland Clinic Investigators: http://portals.ccf.org/occ/EnvironmentalSafety/Biosafety/tabid/6923/Default.aspx
CWRU and Affiliated Investigators: http://case.edu/research/faculty-staff/compliance/hscro/
SECTION-8: INJECTION OF CELLS INTO ANIMALS
Does your project involve the injection or introduction of human stem cells or derivatives into animals?
YES/NO:
If YES, please be sure to review and complete SECTION-4 D of this application.
Is the IACUC project approved?
YES/NO:
If YES, please also provide the following:
Name of IACUC where review request was submitted:
IACUC protocol number:
PI of the IACUC protocol:
Approval Date:
Expiration Date:
Please attach a copy of the IACUC approval letter.
If NO, please provide the following:
Name of IACUC where review request was submitted:
IACUC protocol number:
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PI of the IACUC protocol:
SECTION-9: CERTIFICATION and STATEMENT
9 A. CERTIFICATION: The PI certifies that, in accordance with national and international guidelines, the
following types of experiments will not be performed:
In vitro culture of intact human embryos (including chimeric) or human somatic cell nuclear transfer products for
longer than 14 days of development or until or beyond the onset of gastrulation/primitive streak formation
(whichever comes first);
Introduction of research embryos involving transferred human pluripotent or multipotent cells into any environment
conducive to full-term development; and/or
Breeding of any chimeric animals into which human stem cells have been introduced that may potentially
differentiate into human gametes.
9 B. STATEMENT AND AMENDMENTS:
The research proposed in this request cannot begin until the PI has received written authorization from the
HSCRO Chair and has complied with all other applicable research requirements including but not limited to
IRB/IACUC/IBC review and approval. The PI is responsible for maintaining copies of all required approvals in
laboratory files accessible to internal and external review and audit.
The PI further understands that it is his/her responsibility to inform the HSCRO Chair in writing of any changes to
this research before changes are implemented and to submit an amended or revised proposal to the HSCRO for
review in the event of such changes.
The PI is also responsible for complying with all applicable policies, protocols and practices required in conducting
human stem cell research as well as applicable provisions of federal and state law.
SECTION-10: SIGNATURES
________________________________
Investigator’s Signature
________________________
Date
FOR HSCRO USE ONLY
For the purposes of the use of human stem cells, I have reviewed the merits of this proposal and recommend
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registration or approval.
________________________________
HSCRO Chairperson Signature
_________________________
Date
SECTION-11: CHECKLIST OF ATTACHMENTS: Attach all applicable documents related to your request.
Incomplete applications, including those missing required attachments, will be returned to the PI for
completion.
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Federal grant application excerpt (SECTION-1, funding)
Scientific project description
Independent scientific review
Recent literature search
Material transfer agreement
IRB approval letter
IRB consent form/IRB-approved consent form
IBC approval letter
IACUC approval letter
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