HUMAN STEM CELL RESEARCH IDENTIFICATION PROCEDURES

Office of Research is charged with ensuring compliance with the UCSF Stem Cell Research Policy. A critical element of the process is to identify all research involving the use of human stem cells and ensure that the research conducted is in accordance with the provisions of the policy.

Identification Process

Office of Research requires that Principal Investigators (PI) submit an application for review and/or approval for a number of activities. This includes:

	•	Biological Safety Committee
	•	Cell Culture Facility
	•	Committee on Human Research
	•	Funding applications submitted through Office of Sponsored Research
	•	Institutional Animal Care and Use Committee
	•	Material Transfer Agreements
	•	Radiation Safety Committee

Top of Page

All of the above applications will include a direct question asking if the research involves use of human stem cells, and will say that if the answer is yes approval must be obtained from the Committee on Human Research.

The Committee on Human Research (CHR) application will instruct researchers using human stem cells to complete the Human Stem Cell Research Supplement and
submit it with the application.

Review Process

CHR Office

State of California Law requires that CHR review all human stem cell research. Each research proposal will be reviewed in accordance with the CHR polices and procedures for protocol review.

A CHR coordinator will be review the Human Stem Cell Research Supplement form (“Supplement”) administratively to determine if the proposed study requires review by additional offices at UCSF. The need for additional review is determined in accordance with the Stem Cell Research Review Flow Chart.

If the proposed protocol involves human embryonic stem cell research with cells not on the NIH Human Embronic Stem Cell Registry, the CHR office will forward a copy of the form to the Budget Office at Box 0285 and to the MSO of the PI’s Department.

Top of Page

Budget Office

Budget Office will review the Supplement and determine if additional information related to the research such as the dates of research, effort reporting, the use of funds, facilities, equipment or other activities relating to the proposed study is required. The Budget Office will work with the Office of Sponsored Research, the PI, or designee, to obtain information relevant to the preparation of a UCSF Facilities and Administration Rate Proposal. Any additional considerations will be communicated to the PI and a copy forwarded to the CHR Office for inclusion in the PI file.

Principal Investigator

The PI, or designee, will be responsible for maintaining a copy of the Supplement and has the primary responsibility for communications with the CHR and the Budget Office.

Record Keeping

Each respective office will be responsible for maintaining appropriate records relevant to their operations. Office of Research will modify the CHR database to capture relevant information regarding studies with human stem cells.