UCI Review of Stem Cell Research Guidance – Submitting for hSCRO Review 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…

How to Submit NEW Protocols for hSCRO Review Who can submit hSCRO Protocols at UCI / UCSB? Please review the HRPP “Principal Investigator (PI) Eligibility” webpage. Activities that require hSCRO review at UCI and UCSB must be reviewed and approved by the UCI hSCRO Committee prior to initiation. UCI is the hSCRO of record for…

Modifications 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…

Use of Human Fetal Tissue in research Per NIH Grants Policy Statement Section 4.1.14 (Human Fetal Tissue Research) Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines. Sections 498A…

Additional 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…

Overview All stem cell activities require hSCRO review before they are initiated. Activities involving vertebrate animals will require UCI IACUC approval. Activities involving potentially hazardous biological agents including but not limited to infectious agents, human and non-human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer will…