Frequently Asked Questions
1. What research needs to be reviewed?
All research involving a culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and 2) self-renewal to produce daughter cells with equivalent developmental potential. “Pluripotent” means capable of differentiation into mesoderm, ectoderm, and endoderm. This definition of human stem cell research includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. It also includes the derivation and/or use of induced pluripotent stem cells (iPSCs).
2. How do I obtain ROCSC approval of my research?
To obtain ROCSC review and approval, researchers should an Stem Cell Application to ORCA at Campus Mailstop OMIP.
3. What other relevant committees must also review human stem cell research?
If the projects involves the use of human subjects or individually identifiable private information or biological samples, you must obtain approval from the Institutional Review Board (IRB). http://research.ucsc.edu/compliance/human.html
Research involving non-human animales needs to be approved by the Chancellor's Animal Research Committe (CARC) http://carc.ucsc.edu
Research involving recombinant DNA or human, animal, or plant pathogens needs to be approved by the Institutional Biosafety Committee (IBC) http://ehs.ucsc.edu/.
Stem cell research in general will require adherence to the Cal-OSHA Bloodborne Pathogen Standard (BBP). BBP compliance matters require notice only to UCSC Environmental Health & Safety.
4. When does human stem cell research need to be reviewed by the Institutional Review Board?
Research needs to be reviewed by the Institutional Review Board if it involves:
- Interaction or intervention with living individuals.
- Examples: Identifying patients for donation of residual (fresh) or stored (frozen) embryos for research; clinical investigations involving the use of human stem cells.
- Identifiable private information about living individuals
- Example: Information about the donor(s) is linked to the embryos or cell lines (e.g., medical information) to be created or used.
Click of the this decision tree to help you determine whether you are conducting human subjects research.
5. Is adult or tissue-specific human stem cell research exempt from requirements for ROCSC review?
No. All reserach involving human stem cells needs to be reviewed, including both embryonic and non-embryonic human stem cell research regardless of the tissue of origin.