UCSC Human Stem Cell Research Policy
Adopted by the ROCSC: May 8, 2008
PURPOSE
The purpose of UCSC Human Stem Cell Research Policy is to ensure that all research involving the use or derivation of human stem cells at the University of California, Santa Cruz, is in compliance with state and federal regulations and compliance standards developed by campus committees. This policy pertains only to human stem cell research and is applicable to funds from all funding sources.
DEFINITIONS
Human stem cell research: For the purpose of compliance with state and federal regulations and UCSC policies, "human stem cell research" includes research involving any culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and 2) self-renewal to produce daughter cells with equivalent developmental potential. “Pluripotent” means capable of differentiation into mesoderm, ectoderm, and endoderm. This definition of human stem cell research includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. It also includes the derivation and/or use of induced pluripotent stem cells (iPSCs).
Institutional Review Board (IRB): The IRB at UCSC has the responsibility for review and approval of all human subject and human stem cell research studies at UCSC.
NIH Human Embryonic Stem Cell Registry: A list of human embryonic stem cell lines approved for research with federal funds.
The Research Oversight Committee, Stem Cells (the ROCSC committee): Established in accordance with Code of California Regulations, Title 17, section 100060, the ROCSC is responsible for developing guidelines for all human gamete, embryo and stem cell research; reviewing research protocols as required or needed; reviewing cases of collaborative research; and reviewing and making recommendations on ethical issues.
POLICY
(A) UCSC activities involving human stem cell 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 human stem cell research must be submitted to the Research Oversight Committee, Stem Cells (ROCSC) for review and approval.
(C) Except for purely in vitro research involving approved, de-identified cell lines, all ROCSC approvals must be renewed at least annually.
(D) Additional approvals for human stem cell research must be obtained from the Institutional Biosafety Committee (IBC), the Chancellor’s Animal Research Committee (CARC) or Institutional Review Board (IRB) as appropriate.
(E) Investigators conducting research deriving new human embryonic stem cell lines or using human embryonic stem cells that are not on the NIH Human Embryonic Stem Cell Registry must financially separate the direct and indirect costs of the research and charge the costs to a non-federal funding source.
RESPONSIBILITIES
A. Principal Investigator
In conducting human stem cell research, the Principal Investigator must:
- Understand and comply with applicable University, state, and federal regulations.
- Ensure that all personnel engaged in the research project comply with applicable University, state, and federal regulations.
- Submit a completed Human Stem Cell Research Application to the ROCSC for approval prior to starting the research.
- Obtain applicable approvals required by the ROCSC, IRB, IBC, or CARC.
- Obtain approval from the ROCSC for proposed changes to a protocol prior to initiating the change.
- Obtain continuing ROCSC approval prior to the expiration date of the current protocol.
- Provide the ROCSC Committee with any information or documents requested.
- Complete training as required by the ROCSC.
- Obtain any necessary Material Transfer Agreements (MTA) prior to starting research, complying with all provisions of the MTA or any other agreement associated with the acquisition.
- Distribute human embryonic stem cells or their derivatives only with specific written approval to do so from the entity providing the stem cells.
- Record all information and maintain documents as required by applicable University, state, and federal regulations.
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Coordinating review of Human Stem Cell Research Applications and providing staff support to the ROCSC.
- Providing information regarding human stem cell research to government agencies as required by law.
- Transmitting copies of Human Stem Cell Research Applications to Accounting and Financial Services when necessary.
- Transmitting reports of noncompliance with University, state, and federal policies regarding human stem cell research to the ROCSC for review.
- Performs scientific and ethical review of all human stem cell research.
- Approves, requires modification, or disapproves human stem cell research studies.
- Oversees and monitors issues related to acquiring and using human stem cell lines for research.
- Reviews instances of noncompliance with University, state, and federal policies regarding human stem cell research.
B. Vice Chancellor for Research
The Vice Chancellor for Research appoints the members of oversight and advisory committees and also may invoke special procedures to resolve disagreements regarding stem cell matters.
C. Institutional Review Board (IRB)
The IRB at UCSC has responsibility for review and approval of all human subject research studies at UCSC.
D. Office of Research Compliance Administration
The Office of Research Compliance Administration (ORCA) is responsible for:
E. Research Oversight Committee, Stem Cells (ROCSC)
F. Extramural Fund Accounting (EMF)
The Extramural Fund Accounting Office will be responsible, when necessary, for advising 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, equipment, or other activities relating to the proposed study and what additional action is required.
FURTHER INFORMATION
For further information, contact Office of Research Compliance, (831) 459-4114 or email orca{at}ucsc.edu.