hSCRO Committee Meetings and Deadlines The hSCRO Full Committee meets once a 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 not from federally/state-funded established cell repositories and/or…

Applications & Forms Applications Continuing Application for hSCRO Review New Application for hSCRO Review Checklists Acceptably Derived Cell Line Checklist Guidance Documents hSCRO Flow Chart – Examples of Studies hSCRO Master Flow Chart Protocol Decision Chart Modification Request Forms hSCRO Protocol Modification Request Form Protocol Narratives hSCRO Protocol Narrative Other Forms hSCRO Cell Tracking Table

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,…

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 Reviews for 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 hSCRO before such activities are initiated by or for UCI. The following definition of human pluripotent stem cell population shall apply (CIRM Regulations § 100020): A cell…

How to Submit Protocols to the UCI hSCRO Activities that require hSCRO review must be described in a hSCRO KRP application, which replace and include pre-KRP documents such as the Protocol Narrative and Cell Tracking Table. Please complete each section as prompted in the instruction box. For sections such as the background information, aims, outcome…

Modifications to Approved Research When and How to Modify 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…

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…

Guidelines and Regulations Guidelines for Research on Human Embryonic Stem CellsThe National Academies recommended guidelines for research involving human embryonic stem cells, and urges all institutions conducting such research to establish oversight committees to ensure that the new guidelines will be followed. The guidelines are intended to enhance the integrity of privately funded human embryonic…