Other UCI Reviews that May be Applicable IRB IACUC IBC IRB Stem Cell Projects that Require Institutional Review Board (IRB) Review Activities that meet the federal definition of human subjects research require UCI IRB review and approval: Interactions or interventions with living individuals Examples: Identifying patients for donation of residual (fresh) or stored (frozen) embryos…

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…

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…

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

hSCRO Decision Flowchart 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…

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…

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…

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…

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…

Amendments to hSCRO Approved Research Once a human stem cell protocol has received hSCRO approval, any subsequent changes to the study must be reviewed and approved by the hSCRO Committee prior to implementation. Exception: updates can be made at the time of renewal when generation of new cell lines is ongoing from previously verified material…