Amendments to Approved Research
When and How to Amend an Approved Human Stem Cell Protocol
Once a human stem cell protocol has received hSCRO approval, any subsequent changes to the study must be reviewed and approved by the hSCRO 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.
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, an amendment 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.
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.
Types of Amendents
Amendments are categorized into Administrative Review, Expedited Review and Full Committee Review changes.
Amendments requiring Administrative Review:
- Deletion of non-key study personnel
- Updates to study locations and cell storage locations.
- Deletions of cell lines.
Amendments requiring an Expedited (Subcommittee) hSCRO 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.
Amendments requiring hSCRO Full Committee Review:
*Note: hSCRO Full 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.
Approval of submitted amendments are documented in an approval letter to the Lead Researcher, and copied to the Faculty Sponsor (if applicable). Approved amendments are appended to the protocol in KRP.
NOTE: Approved amendments do NOT extend the approval period of the protocol.