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. To request approval of a proposed modification, complete and submit a hSCRO Protocol Modification Request Form.
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.
Instructions:
- Prepare a revised version of the approved protocol narrative using tracked changes.
- Submit by email the Modification Request Form and the revised protocol narrative (from the LR) to Cathryn Lucas, hSCRO and RDRC Administrator, cathryn.lucas@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 minor changes and significant changes.
Minor modification/change - A proposed change in research related activities that do not significantly affect the hSCRO’s assessment of the ethical and social issues presented in the approved study and does not substantially change the specific aims or design of the study. Minor changes may undergo Expedited (subcommittee) review.
Significant modification/change - A proposed change in research related activities that significantly affects the hSCRO’s assessment of the ethical and social issues presented in the approved study or substantially changes the specific aims or design of the study. Significant modifications/changes require review by the full Committee.
Examples:
Examples of minor changes to a research study include but are not limited to, the following:
- Addition or deletion of study team members.
- Addition of cell lines or procedures that fall under any of the expedited categories usually qualify as minor modifications:
- Purely in vitro uses of NIH registered and UK Stem Cell Bank human stem cell lines.
- Purely in vitro uses of human adult stem cells that are not pluirpotent or do not involve attempts to establish pluripotency.
- Purely in vitro uses of acceptably derived hESC lines when the UCI hSCRO has on record documentation of the provenance of the cell lines.
- Removal of cell lines or research procedures that would reduce the ethical and social concerns of a given study.
Examples of significant changes to a study may include, but are not limited to, the following:
- In vivo uses of human stem cell lines. Note: Adding in vivo procedures to in vitro research studies may necessitate a new protocol submission.
- Addition of existing acceptably derived hESC line when the UCI hSCRO does not have on record documentation of the provenance of the cell lines.
- Addition of a new stem cell derivation method.
Notification
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.
