How to Submit Protocols to the UCI hSCRO
hSCRO Protocol Submission Procedures
The electronic IRB Application and Appendix R- “Use of Human Gametes, Embryos or Derivation/Use of Human Stem Cells” are used for protocol submissions to the UCI hSCRO. The guidance below will assist investigators with completion of the IRB Application and Protocol Narrative for human embryos and human stem cell lines.
Under Level of Review:
- Investigators who will use established stem cell lines for in-vitro uses should check "Exempt Registration, Category 4" if no private, identifiable information about the donors is linked to the cell lines. If private, identifiable information about the donors is linked to the stem cell lines, check "Expedited Review, Category 5".
- Investigators who will derive new stem cell lines for in-vitro or in-vivo uses should check "Full Committee Review, Biomedical" if prospective subjects will be consented for embryo donation. Informed consent from donors to use embryos for the research is required if all of the embryos are not yet available for use at the time research is proposed.
Under Subject Populations:
- Most in-vitro uses human stem cell lines will not involve human subjects as defined by federal regulations (i.e., no private, identifiable information about the donors is linked to the cell lines).
- Investigators who will use established stem cell lines for in-vitro uses should check "Use of Established Human Stem Cell Lines Only” under the Populations section of the IRB Application.
- Investigators who will derive new stem cell lines for in-vitro or in-vivo uses should check a subject population box that best describes the individuals who will donate embryos for research. "Adults Who Are Competent to Give Informed Consent (no surrogates)” will be the subject population box most frequently checked. Details of how informed consent was (or will be) obtained should be described in Section 4 of the IRB Protocol Narrative.
Under Study Procedures:
- All investigators should check "Use of Human Embryos or Derivation/Use of Human Stem Cells" under the Procedures section of the IRB Application to assure Appendix R for stem cells generates.
- Investigators who wish to store embryos for derivation of new lines or maintain new stem cell lines created at UCI should check "Storage of Data and/or Specimens for Future Research" under the procedures section of the IRB application to assure Appendix M generates.
Which Protocol Narrative should I complete?
The hSCRO Protocol Narrative is used for stem cell activities that do not involve the human subjects; typically, in-vitro activities using existing cell lines and in-vivo use of existing cell lines in animals.
If the use of human gametes, embryos or stem cells involve interactions or interventions with living individuals, the IRB Protocol Narrative must be completed. Examples: identifying patients for donation of residual (fresh) or stored (frozen) gametes or embryos for research; clinical investigations involving the use of human stem cells.
If the use of human gametes, embryos or stem cells involves access to private, identifiable information about living individuals, the IRB Protocol Narrative must be completed. Example: identifiable information (e.g., medical information) about the donor(s) is linked to the gametes, embryos or cell lines to be created or used.
Completing the IRB Protocol Narrative:
- A response to each section of the narrative is required. There are many checkboxes that can be used to indicate a given section does not apply to the research.
- Section 2: Identify all study team members who will interact with living individuals or study team members who will work with the stem cell lines.
- Section 3: Provide details about the procurement of the embryos and/or the in-vitro or in-vivo uses of human stem cell lines.
- Section 4: The subjects of the research are individuals who provide consent for embryo donation or individuals who will be the recipients of a stem cell treatment.
- Section 6: Details about the informed consent process must be provided for studies that derive new stem cell lines for in-vitro or in-vivo use. If private, identifiable information is linked to the stem cell lines, a waiver of informed consent may be requested (Appendix O is required—see Study procedures section of the IRB Application).
Please review the hSCRO Program Policy and Procedures for additional information to include with your submission.
Questions about Submitting to the UCI hSCRO
Feel free to contact the Office of Research Administration if you have any questions about the hSCRO process or how to complete the IRB application.
- Cathryn Lucas, hSCRO and RDRC Administrator, 949-824-7218, cathryn.lucas@uci.edu
- Professor Sidney Golub, hSCRO Chair, 949-824-9319, sgolub@uci.edu
