Effective Date: December 2024
Revision Date: N/A
Responsible Office: URA
Policy Statement
The University of Chicago is committed to the ethical and responsible use of human embryonic stem (hES) cells in research. As such, UChicago’s participation in hES cell research will be conducted in accordance with the general principles expressed in the Guidelines for Human Embryonic Stem Cell Research (NAS, 2005).
Applicability
UChicago is engaged in hES cell research subject to this policy and ESCRO committee review if the research is:
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Conducted by UChicago faculty, staff or students; or
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Performed on the premises of UChicago; or
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Using equipment belonging to UChicago; or
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Using funds administered by UChicago; or
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Satisfying a requirement imposed by UChicago for the award of a degree or the completion of a course of study; or
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Conducted by adjunct faculty, including non-salaried faculty, with the intention of citing UChicago affiliation in a publication or study documents.
Policy Ownership
Responsible Office: University Research Administration
Originally issued: December 2024
Current version effective date: December 2024
Last Updated: December 2024
Definitions
Human embryonic stem cell research (“hES cell research”) |
All derivations of hES cell lines and all research using hES cells derived from:
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UChicago ESCRO policies |
This document and others linked in the section “Related Information” which collectively govern hES cell research at UChicago. |
Policy:
In 2024, the University of Chicago authorized establishment of a committee with oversight responsibility for all institutional hES cell research. The committee shall review all proposed and ongoing hES cell research engaged in by UChicago and maintain a registry of all hES cell lines that are imported into or maintained at UChicago. The committee shall be called Embryonic Stem Cell Research Oversight (ESCRO). ESCRO shall have authority to review and approve the following areas of research in which UChicago is engaged:
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All established hES cell lines listed on the National Institutes of Health (NIH) Human Embryonic Stem Cell Research Registry (http://stemcells.nih.gov/research/registry/);
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All established hES cell lines that are not currently listed on the NIH Registry*; and
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All new hES cells lines derived from one of the following sources*:
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Human blastocysts made for reproductive purposes and later obtained for research purposes from IVF clinics, or
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Human blastocysts made specifically for the purpose of research using assisted reproductive technologies, or
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Human somatic cell nuclear transfer (NT) into human oocytes for the purposes of creating hES cells.
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Research that is not permitted to be undertaken by UChicago shall include the following:
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Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first;
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Research in which hES cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts;
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Research that involves the breeding of any animal into which hES cells have been introduced at any stage of development; or
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Research that involves human somatic cell NT for the purpose of reproductive cloning.
ESCRO shall advise the UChicago leadership in all matters relating to UChicago use and procurement of hES cells and shall assure that all such research complies with all policies contained within this and related documents.
ESCRO shall develop and provide appropriate training for UChicago investigators on the conduct of research using human embryonic stem cells.
The University of Chicago is responsible for providing adequate resources to ESCRO to facilitate its charge, including the provision of meeting space, staff support, etc. University Research Administration, will manage the resources until and unless a more suitable office is identified.
The UChicago leadership may not override an ESCRO denial of approval. However, even after ESCRO has approved research, UChicago leadership may require further institutional review and may make the determination that certain types of hES research may not be undertaken at UChicago.
Consequences of Non-Compliance
Alleged deviations from the UChicago ESCRO policies should be reported to the ESCRO Chair for investigation, resolution, and reporting to UChicago leadership and other UChicago committees with shared jurisdiction as applicable (IRB, IBC, etc.). The ESCRO Committee shall have the authority to suspend or terminate its approval of hES cell research that is not being performed in compliance with UChicago ESCRO policies, other UChicago policies, applicable state or federal laws, regulations, and/or the general principles expressed in the NAS Guidelines for Human Embryonic Stem Cell Research.
The ESCRO Committee, through the applicable leadership official, shall report suspension or termination of research to external funding sources, if applicable. The applicable UChicago leadership official, or designee, has the authority to further review suspected deviations and to suspend or terminate approval of hES cell research.
Related Information
The following documents outline additional policies and procedures regarding ESCRO oversight of hES cell research at UChicago:
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ESCRO Membership
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ESCRO Protocol Application
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ESCRO Protocol Submission and Review
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ESCRO Scope
The ESCRO Committee may develop additional policies, guidelines, and/or procedures to execute its charge. Such documents will be made available to the UChicago community.