Submitting hSCRO Renewals

Submitting a Renewal (Renew & Amend) Application in KRP: Per CDPH Guidelines for Human Stem Cell Research “SCRO Committee approvals shall be reviewed no less frequently than once per year. The renewal review shall confirm compliance with all applicable rules and regulations.” As such, UCI hSCRO Approvals are issued for one year. The Lead Researcher…

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hSCRO Committee Calendar

hSCRO Committee Meetings and Deadlines The hSCRO Full Committee meets once a month on the first Thursday of the month and will review the following types of submissions: All New research protocol submissions which require hSCRO review Addition of new cell lines or materials as listed under “Activities that required hSCRO review” if materials are…

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hSCRO Forms & Guidance

Forms and Guidance Documents Forms   UCI Lead Researcher Statement related to use of Fetal Tissue 09-14-2023   Guidance Documents Acceptably Derived Cell Line Checklist hSCRO Flow Chart – Examples of Studies hSCRO Master Flow Chart Protocol Decision Chart

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hSCRO Decision Trees

hSCRO Decision Trees Do I need to submit a new hSCRO protocol or a modification of an existing hSCRO protocol for the following research activities performed at UCI? Do you intend to use… Human gametes, Human embryos, Human adult pluripotent (pluripotent=can differentiate into all 3 germ lineages) Human fetal tissue, Human fetal stem cells, or,…

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Cell Line Provenance Policy

Cell Line Provenance Policy Proposed MaterialInformation, Examples, etc.Provenance Documents To Be Submitted By Investigators Registered Pluripotent Cell Lines• NIH Registered • CIRM Registered • UK Stem Cell Bank • UK Human Fertilization & Embryology Authority • Canadian National Stem Cell Oversight Committee • Japanese Guidelines for Derivation & Utilization of Human Embryonic Stem CellsAppropriate registry…

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hSCRO FAQs

Frequently Asked Questions I would like to use adult stem cells in my research. Do I need hSCRO approval? The use of adult tissue specific stem cells, such as hematopoietic cells or mesenchymal cells, does not require UCI hSCRO approval UNLESS such cells have been shown to, or are being induced to differentiate into the…

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Activities that Require hSCRO Review

UCI Review of Stem Cell Research All research or clinical investigations that involve the use of pluripotent human stem cells shall be reviewed and approved by the UCI Human Stem Cell Research Oversight Committee (hSCRO) before such activities are initiated by or for UCI. UCI has a Memorandum of Understanding (MOU) with the University of…

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How to Submit Protocols to the UCI hSCRO

How to Submit NEW Protocols for hSCRO Review Activities that require hSCRO review must be described in a hSCRO KRP application. Review UCI’s HUMAN STEM CELL RESEARCH OVERSIGHT PROGRAM POLICY AND STANDARD OPERATING PROCEDURES Please complete each section as prompted in the instruction box. For sections such as the background information, aims, outcome variables, methods and…

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Modifications to Approved Research

Amendments to Approved Research When and How to Amend an Approved Human Stem Cell Protocol Once a human stem cell protocol has received hSCRO approval, any subsequent changes to the study must be reviewed and approved by the hSCRO prior to implementation. Exception: updates can be made at the time of renewal when generation of…

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Use of Human Fetal Tissue in research

Use of Human Fetal Tissue in research Definitions: Per US Federal regulation 42 U.S. Code § 289g–1 – Research on transplantation of fetal tissue, the term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth. For NIH supported research…

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