Research Policy Handbook

Human Stem Cell Research (RPH 10.7)

Current Version: June 10, 2010

Summary:

Discusses issues related to research involving:

• Development or use of human pluripotent stem cell lines, including human Embryonic Stem Cells (hESC), stem cells derived by Somatic Cell Nuclear Transfer (SCNT), and Induced Pluripotent Stem Cells (iPSC)
• Human non-pluripotent stem cells, including cancer stem cells, progenitor cell populations containing stem cells, mesenchymal stem cells, and fetal-derived stem cells
• Human embryos and parthenotes
• Human gametes: oocytes, sperm

Also establishes a combined Institutional Review Board/Stem Cell Research Oversight Panel (IRB/SCRO) to advise the Vice Provost and Dean of Research regarding issues related to the conduct of human stem cell research at Stanford.

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This statement contains Stanford University's policy regarding the conduct of human stem cell research and applies to all who conduct such research at Stanford. The Vice Provost and Dean of Research is responsible for interpretation and overall coordination of the policy. Violation of any part of this Policy may cause a faculty member to be subject to sanctions as described in the Statement on Faculty Discipline. This policy will be modified as necessary to comply with all applicable regulations and statutes.

DEFINITIONS

• �Human embryonic stem cells� (hESC) are derived from human embryos;
• �Nuclear transfer derived stem cells� (nt-hESC) are derived from human blastocysts generated by Somatic Cell Nuclear Transfer (SCNT);
• �Induced Pluripotent Stem Cells� (iPSC) are derived from somatic cells.

All of the above are pluripotent cells that are self-renewing and capable of developing into cells and tissues of the three primary germ layers: endoderm, mesoderm, and ectoderm. Although human embryonic stem cells may be derived from embryos, such stem cells are not themselves embryos. Non-pluripotent stem cells, sometimes referred to as �adult� stem cells, are those cells that can self-renew but are not considered capable of developing into cells and tissues of all three primary germ layers.

GENERAL PRINCIPLES

California law requires that human stem cell research that requires review be reviewed and approved by a stem cell research oversight committee. In addition, the State of California has mandated that all human embryonic stem cell research funded by the California Institute for Regenerative Medicine (CIRM) must be undertaken with "..full consideration of the ethical and medical implications of this research." (California Health and Safety Code Section 125300).

Similarly, the State of California has mandated that "research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplantation, shall be reviewed by a stem cell research oversight committee." (California Health and Safety Code Section 125300)

In light of these considerations, Stanford University has established the following policy related to human stem cell research. Research involving human stem cells that require review must follow existing University policies and undergo IRB/SCRO review and approval. This policy is supplemental to, and in no way takes the place of, existing policies for all activities, including the conduct of human subjects research. Researchers can find additional information at Stem Cell Research Oversight at Stanford University (https://scro.stanford.edu)

The goals of this policy are to ensure that:

1. Stanford University is aware of all relevant human stem cell research activities conducted by University faculty, staff, postdoctoral scholars, students and visiting scholars, including, to the maximum extent possible, the sources or derivation of any human pluripotent stem cells planned for use or being used;
2. every person at Stanford working on such research is fully aware of the compliance requirements associated with the work, including the requirement for annual review;
3. Stanford complies with any special reporting requirements for such research imposed by federal, state and local regulations, and by sponsors and donors;
4. existing SCRO protocol review procedures are followed, and
5. provisions exist to monitor compliance with this policy continuously and make changes in it as are deemed appropriate.

DISCUSSION AND DETAIL

1. Tracking all Human Stem Cell Research undertaken at the University or by University Principal Investigators
   

   Any research proposals for funding to support research involving human stem cells must be identified on the Stanford Proposal Development and Routing Form (PDRF). Such research will require SCRO notification or IRB/SCRO review and approval prior to initiating research involving human stem cells. In addition, it may be necessary to file a Human Subjects protocol application (see Stem Cell Research Oversight website, https://scro.stanford.edu).

2. Guidelines that Regulate Stem Cell Research
   

   Because of the complexity of rules and restrictions associated with such research, all University personnel, including faculty, staff, postdoctoral scholars, and students, as well as visiting scholars and other researchers, who plan to engage in its conduct are required to complete training before they begin work on any project involving human embryonic stem cells.

   1. State Guidelines: California State law regulates all research involving human stem cells with the exception of research funded exclusively by the California Institute for Regenerative Medicine (CIRM). Information can be found on the California Department of Public Health Stem Cell Research website: https://www.cdph.ca.gov/programs/HSCR.
   2. California Institute for Regenerative Medicine Guidelines: The CIRM Medical and Ethics Standards working group (MES) provides guidelines for CIRM-funded research involving human stem cells. These guidelines are effective for all research supported in full or in part by CIRM. Information can be found on the CIRM website: https://cirm.ca.gov.
   3. NIH Guidelines: The National Institutes of Health Guidelines for Human Stem Cell Research are effective as of July 7, 2009. These Guidelines apply to other federal departments and agencies as well. These Guidelines are published at https://stemcells.nih.gov/policy/2009guidelines.html.
      
      Research involving human stem cells may be regulated by one or more of the above guidelines, depending on funding sources, applicable regulations and standards, and the University�s policies.
3. Responsibilities of the Vice Provost and Dean of Research
   The Vice Provost and Dean of Research is the University official responsible for interpreting and overseeing implementation of and compliance with this Policy. Questions may be addressed to the Vice Provost and Dean of Research, or to the Research Compliance Director.
4. Institutional Review Board/Stem Cell Research Oversight Panel (IRB/SCRO)
   In order to provide the required oversight for human stem cell research, the Vice Provost and Dean of Research has established the IRB/SCRO Panel within the Research Compliance Office (RCO). As mandated by State Law, all University research projects involving human stem cells must be reviewed and approved by the IRB/SCRO Panel. Such review by the IRB/SCRO Panel shall be in accordance with all relevant University policies, federal, CIRM, and state regulations. The IRB/SCRO Panel, reporting to the Vice Provost and Dean of Research, is responsible for providing scientific and ethical review of all proposed research projects involving all human stem cells. This review is in addition to other compliance panel reviews that may be required such as Animal Care and Use, or Biosafety. Under no circumstances may the research begin before these approvals are granted.
5. Material Transfer Agreements
   The transfer of human stem cell lines into or out of the University must be authorized under a Material Transfer Agreement (MTA) signed by:
   1. Stanford's Industrial Contracts Office (ICO);
   2. the providing or receiving researcher (at Stanford); and
   3. the providing or receiving party (outside of Stanford).
   An MTA typically obligates the recipient and the recipient�s employer to abide by specific restrictions and limitations on use of the cells, consistent with the consent obtained, and with applicable federal and state laws and regulations. Before finalizing an MTA for stem cells brought into the University, the Industrial Contracts Office (ICO) requires confirmation that the proposed research is approved by the IRB/SCRO Panel and any other required entities. The fully executed MTA must be in place before cells are received in a Stanford lab. Information on MTAs is available at https://www.stanford.edu/group/ICO/researcher/reMTA.html
   

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