Modifications to Approved Research
When and How to Modify 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.
Most proposed modifications require changes to the approved protocol documents (e.g., the protocol narrative, the informed consent form). The investigator must submit an updated version of each document for hSCRO review. When updating the Protocol Narrative and any other supporting documents, use your word processor's "track changes" feature.
- Prepare a revised version of the approved Protocol Narrative using the "track changes" feature of your Word program.
- Submit by email the completed Modification Request Form and the revised protocol narrative (from the LR) to hSCRO@research.uci.edu.
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 Modifications
Modifications are categorized into Administrative Review, Expedited Review and Full Committee Review changes.
Modifications requiring Administrative Review:
- Updates to study team members so long as key research personnel are not deleted from the study team.
- Updates in study locations and cell storage locations.
- Deletions of cell lines.
- 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.
Modifications requiring an Expedited Review:
- Proposed changes in research related to activities that do not significantly affect the assessment of the ethical and socail issues, and do not substantially change the specific aims or design of the study.
- Addition of teratoma assay standard in vivo procedure.
Modifications requiring Full Committee Consideration:
- 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.
- In vivo transplantation of pluripotent stem cells, cells of fetal origin or neural stem cells (with the exception of the addition of teratoma assays which qualify for expedited review.)
- Deletions of key research personnel.
- Proposed changes to the research aims or goals.
- The Lead Researcher may request a Continuation Review at the time of a Full Committee Modification Request. The Lead Researcher must submit both a Modification Request Form with "tracked changes" Protocol Narrative AND a Continuation Application.
Approval of submitted modification requests are documented in an approval letter to the Lead Researcher, and copied to the Faculty Sponsor (if applicable). Approved modifications are appended to the protocol in the official hSCRO file.
NOTE: Approved modifications do not extend the approval period of the protocol.
Requesting a Continuing Review at the time of a Modification Request
A Continuation 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.