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How to Submit Protocols to the UCI hSCRO

hSCRO New Protocol Submission Procedures

Investigators are encouraged to review the list of activities that require hSCRO review which are listed on the application and on the webpage: Activitites that Require hSCRO Review.

Three (3) documents are to be completed and submitted to request the review of a study by hSCRO.

1. Protocol Narrative

Each submission prepared for hSCRO review must include a Protocol Narrative.

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.

2. Cell Tracking Table

Material:
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 would be listed in Section 3 of the narrative.

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).

Supplier:
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 iPSCs,

Registry Number:
For human embryonic stem cells only, list the specific NIH, CIRM, UK Stem Cell Registry number.

3. Application for hSCRO Review 

The Application for hSCRO review must be completed for protocol submissions to the UCI hSCRO. The guidance below will assist investigators with completion of the hSCRO Application and Protocol Narrative.

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.

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:
The Department/ Organized Research Unit (ORU) Chair/Director’s or designee’s assurance statement must be signed on the application.

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.

The application must be signed and dated by the Lead Researcher/Principal Investigator.

Questions about Submitting to the UCI hSCRO

Feel free to contact hSCRO@research.uci.edu if you have any questions about the hSCRO review process or how to complete the hSCRO application.

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