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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
HSCRO Application Form: Version December 2012, Revised July 2013, Revised November 2013
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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:
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.
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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:
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:
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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:
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.
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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.
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
HSCRO Application Form: Version December 2012, Revised July 2013, Revised November 2013
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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.
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:
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http://ora.ra.cwru.edu/research/orc/rdna/indxPg_Cwru_ibc.cfm
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:
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:
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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 registration or approval.
________________________________
HSCRO Chairperson Signature
_________________
Date
HSCRO Application Form: Version December 2012, Revised July 2013, Revised November 2013
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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.
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.
HSCRO Application Form: Version December 2012, Revised July 2013, Revised November 2013