OFFICE OF ORIGIN: OFFICE OF RESEARCH

I. Purpose

This policy ensures that all research involving the use of human stem cells at the University of California San Francisco (UCSF) is in compliance with all adopted State and Federal regulations and compliance standards developed by campus committees.

II. Definitions

Human Gamete, Embryo, and Stem Cell Research Committee (the GESCR committee): This Committee serves as an advisory body to the Executive Vice Chancellor and the Committee on Human research. It is responsible for:

	•	Developing guidelines for the campus with respect to research involving all human gamete, embryo and stem cell research. In particular, in accordance with the recommendations of the National Academies of Science, the committee will develop guidelines that: Establish categories of research that require different levels of oversight such as research that is: permissible after appropriate review by the Committee on Human Research, Institutional Animal Care and Use Committee, and Biological Safety Committee, permissible only after additional review by this committee, and not permitted at this time. Addresses transplantation of human cells into nonhuman animals. Address the derivation of new hESC lines, including the confidentiality of the donors of the biological materials used to derive the lines Establish and maintain a registry of hESC investigators, the types of research being carried out, and the hESC lines in use (including the provenance of the hESC).
	•	Review protocols as required or needed.
	•	Review cases of collaborative research with investigators in another country to determine if procedures prescribed by the foreign institution afford protections equivalent to US, Calfornia, and UCSF guidelines and if some or all of the foreign procedures may substitute for its own.
	•	Review and make recommendations on ethical issues regarding human gamete, embryo, and stem cell research when requested by the Executive Vice Chancellor, Campus Oversight and Advisory Committees, or individual researchers.
	•	Providing advice, as needed, on other ethical issues relating to research projects.

Institutional Review Board (IRB): The CHR is the IRB at UCSF with the responsibility for review and approval of all human subject and human stem cell research studies at UCSF.

NIH Human Embryonic Stem Cell Registry: A list of stem cell lines approved for research with Federal Funds.

Stem Cell Research: For the purpose of compliance with State regulations and UCSF policies, the term “human stem cell research” includes research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, human umbilical cord stem cells, and human adult stem cells from any source. Human somatic cell nuclear transplantation and use of stem cells derived from nuclear transfer are also considered “human stem cell research.”

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III. Policy

	A.	UCSF activities involving any human stem cell, embryonic or adult, research shall be in accordance with the applicable state and Federal regulations and funding governing such research, including any restrictions on the use of Federal funds for such research.
	B.	All individuals conducting human stem cell research must submit a protocol to CHR for review and approval prior to initiation of the study. This must be done even if there are no plans to put such cells into human subjects. The application includes the “Human Stem Cell Research Supplement.”
	C.	Additional approvals must be obtained from the Biological Safety Committee (BSC) or Institutional Animal Care and Use Committee (IACUC) as appropriate.
	D.	Investigators conducting research deriving or using human embryonic stem cells that are not on the NIH Human Embryonic Stem Cell Registry must follow UCSF Human Stem Cell Research Guidelines and to financially separate the direct and indirect costs of that research and charge the costs to a non-Federal funding source.

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IV. Responsibility

A. Executive Vice Chancellor
	The Executive Vice Chancellor appoints the members of oversight and advisory committees and also may invoke special procedures to resolve disagreements regarding stem cell matters.
B. Associate Vice Chancellor, Research
	The Executive Vice Chancellor has delegated the operational oversight of this policy to the Associate Vice Chancellor, Research.
C. Principal Investigator
	In conducting human stem cell research the principal investigators must conduct their research in compliance with applicable state and Federal regulations, restrictions on use of Federal funds for such research, and any conditions of approval required by the CHR, IACUC or BSC. Enforcement and sanctions shall be in accordance with “The Faculty Code of Conduct” (APM-015) in the Academic Personnel Manual.
D. Office of Research
	Office of Research is responsible for:
		•	Obtaining the information on the “Human Stem Cell Research Supplement” form regarding any stem cell research at UCSF through one of the following mechanisms:
			•	Committee approval process (BSC, CHR, and IACUC),
			•	Office of Sponsored Research (OSR) contracts or grant application, or
			•	Material Transfer Agreements (MTA) applications.
		•		Forwarding the “Human Stem Cell Research Supplement” and the "Request for hESC Equipment Approval" forms to the appropriate offices for review and approval.
F. Budget Office
	Budget and Resource Management Office will be responsible for reviewing all “Human Stem Cell Research Supplement” forms and, if necessary, advising the Office of Research and the Principal Investigator if there are specific restrictions and/or information requirements related to the research such as the dates of research, effort reporting, the use of funds, facilities, or other activities relating to the proposed study and what additional action is required.

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V. Related Policies

	•	100-16 Research Involving Human Subjects
	•	100-17 Research and Instruction Using Animal Subjects ·
	•	100-24 Biosafety
	•	150-23 Reporting Improper Governmental Activities and Protection Against Retaliation ("Whistleblowing")
	•	400-10 Academic, Legal and Financial Policies of Contracts and Grants

VI. Reference

	•	Title-42, Chapter 6A, Part H, Section 289g-2, Prohibitions regarding human fetal tissue
	•	Title-21, Food an Drugs, Part 600 Biological Products
	•	Title-45, Code of Federal Regulations, Part 46, Protection of Human Subjects
	•	OMB Circular A-21: Cost Principles
	•	NIH Stem Cell Information (Policies, Administrative Statements, etc.)
	•	California Law Chapter 789
	•	California Embryonic Stem Cell Guidelines
	•	California Policy on HESC Research
	•	California Stem Cell Research and Cures Bond Act of 2004
	•	California Stem Cell Research Institute Requirements
	•	UCSF Office of Research Website