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 variables, methods and procedures, the investigators are encouraged to provide information listed in grant applications to ensure that the Committee has sufficient and complete information for review.
- Study Funding:
Investigators should provide information related to the source of funding for their project.
- Other UCI Committee approvals:
Indicate all applicable committee reviews that are required for this research. If a protocol has already been approved specify the protocol number (Please note Conflict of Interest Oversight Committee (COIOC) review is not applicable to hSCRO regulated research).
- Location and Storage of Cells:
Indicate the location (building and room number) for research activities (cell culture, animal experiments) and storage of materials.
- Departmental Approval:
An assurance statement is prompted via a KRP email notification (with subject line “Ancillary Partner Clearance Required"), sent to the Department/ Organized Research Unit (ORU) Chair/Director or their designee.
- Lead Researcher Certification:
Lead Researcher/Principal Investigator must review the list of responsibilities which must be met to ensure adequate conduct and oversight of the study.
When completing the KR Protocol information, under the section “Cell Line Provenance”, consider the following:
Each cell line or material such as human embryonic cell line, human induced pluripotent stem cell line, embryo, oocyte, fetal tissue or fetal-tissue derived cell lines, neural stem cells that will be used in animals must be listed individually on a separate row.Non-human cell lines, cell lines that are not pluripotent (except for fetal-tissue origin multipotent stem cells or neural progenitors cells to be used in vivo) will NOT need to be listed in the Cell Tracking Table.Somatic cells (fibroblasts) that have not yet been used to create pluripotent lines should NOT be included in the Cell Tracking Table. Instead, somatic cells which are stored for later use should be mentioned under "Location and Storage of Cells" section of KR Protocol.
- Cell Line Name / ID:
Each cell line must be listed with either their name or ID. If multiple cell lines are made from the same source (for example, if multiple iPSCs are made from the sample fibroblast line, each iPSCs line should be listed separately).
List the name or the individual or institution that will directly supply the material. Examples are provided in the table.
- Provenance / Source Information:
List the specific Cell Registry, UCI or non-UCI IRB-approved protocol number under which the source material was collected or the Company and the Catalog number for somatic cells used to generate iPSCsFor materials such as induced pluripotent stem cells, fresh somatic cells, or Non-Registered Embryonic Pluripotent Cell Lines, upload the following documents in KR under attachments:
- A sample Consent Document
- IRB (or equivalent ethics review) Approval Letter (this can be replaced by an IRB-stamped approved sample consent)
- In some instances (such as cell lines from Coriell), the approved consent form can be replaced by a statement from the providing company or institution indicating specimens are de-identified, no access to the key code will be granted,
- and appropriate IRB (or equivalent) oversight was in place at the time of donation is acceptable.For fetal tissue materials, upload documents as described under the webpage https://research.uci.edu/human-stem-cell-research/use-of-human-fetal-tissue-in-research/.For details related to provenance documents to submit, review the Cell Provenance Policy table at https://research.uci.edu/human-stem-cell-research/guidelines-and-regulations/cell-line-provenance-policy/.
- Registry Number:
For human embryonic stem cells only, list the specific NIH, CIRM, UK Stem Cell Registry number.
Submitting a Continuing Review (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 must submit a Renew & Amend in KRP prior to protocol expiration. **It is recommended that researchers submit their renewals 8 weeks prior to the expiration date noted on their hSCRO approval letter.
- There is no grace period extending the conduct of the research beyond the expiration date of hSCRO approval period.
- **If a protocol expires, all work with hSCRO approved stem cell lines must be suspended until hSCRO approval is granted!
- All research approved by the hSCRO Full Committee qualifies for Expedited Continuing Review unless the research has had any instance of noncompliance or unanticipated problems during the previous year of approval.
- Personnel updates (removal or addition of personnel, including lead researcher changes) are allowed at the time of Continuing review.
- Addition of new stem cell lines is allowed at the time of continuing review (i.e. a modification will not be required to add each line) for protocols that include continuous generation of stem cells if the source material used to create new lines has been collected at UCI using an active UCI IRB-approved Consent or whose provenance documentation has already been reviewed for this protocol.
- Once a protocol has been approved by the hSCRO, it is the LR’s responsibility to maintain hSCRO approval until all uses of gametes, blastocysts and cell lines have concluded.
- A Continuing Application may be submitted along with a Full Committee Modification Request. At the time of the review both the Full Committee Modification Request and Continuation Application will be considered simultaneously.
- See UCI hSCRO Policy for details