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 if collected under an active UCI IRB-approved protocol.
Changes must not be implemented until hSCRO approval is granted. Other Institutional Committee (i.e., IRB, IACUC, IBC) approvals may also be required prior to initiation of the changes.
If source materials such as skin biopsies, blood, fibroblast cell lines or any other applicable materials are procured with the intent of creating induced pluripotent cell lines, a modification must be submitted for hSCRO review and approval PRIOR to generating the iPSCs to ensure the provenance can be verified prior to making the significant efforts to generate iPSCs.
Types of Modifications
Modifications are categorized into Administrative Review, Non-Committee Review and Committee Review changes.
Administrative Review:
- Deletion of non-key study personnel
- Updates to study locations and cell storage locations.
- Deletions of cell lines.
Non-Committee Review:
*Note: hSCRO Subcommittee meetings occur on a weekly basis*
- Additions of registered cell lines, cell lines/materials that have been been previously approved by the UCI hSCRO or cell lines obtained from source material that has previously been verified by UCI hSCRO. Note: Federally/state-funded cell repositories are considered already verified sources.
- Proposed changes in research related to activities that do not significantly affect the assessment of the ethical and social issues, and do not substantially change the specific aims or design of the study.
- Addition of teratoma assay standard in vivo procedure.
Committee Review:
*Note: hSCRO Committee meetings occur on the first Thursday of the month
- Proposed changes in research related activities that significantly affect the assessment of the ethical and social issues, and substantially change the specific aims or design of the study.
- Additions of cell lines (ES, iPS, fetal, neural, per Section III.I) that are not registered on one of the acceptable registries, or have not been previously approved by the UCI hSCRO.
Notification
Approval of submitted modifications are documented in an approval letter to the Principal Investigator, and copied to the Faculty Advisor(if applicable). Approved modifications are appended to the protocol in Zot hSCRO.
NOTE: Approved modifications do NOT extend the approval period of the protocol.