1. UCSF activities involving any human stem cell research shall be in accordance with the applicable federal, state and funding agency regulations governing such research, including any restrictions on the use of federal funds for such research as issued under the NIH Stem Cell Guidelines.

2. All individuals conducting human stem cell research must submit a GESCR application for review and approval prior to initiation of the study.

3. Additional approvals must be obtained from the Institutional Biosafety Committee (IBC) or Institutional Animal Care and Use Committees (IACUC) as appropriate.

4. Investigators who are conducting research deriving or using human embryonic stem cells that are not on the NIH Human Embryonic Stem Cell Registry must adhere to all terms of the NIH Stem Cell Guidelines, and should charge the costs of the research to appropriate non-Federal funding sources.

5. When managing federal funds for projects using human embryonic stem cell lines that are on the NIH Human Embryonic Stem Cell Registry, investigators must adhere to all federal cost principles as clarified under the UCSF Cost Accounting Standards (CAS) Guidelines (Charging Practices for Sponsored Projects).

The GESCR Committee requires that all state and/or federal requirements are met before a human stem cell line can be approved by the Committee. The pre-approval considerations may include, but are not limited to, consent from the gamete and/or embryo donors and payment reimbursement of donors. There may be conflicts between state and federal guidelines/regulations. The GESCR Committee reviews the history of all stem cell lines and weighs this information with the state and federal guidelines/regulations to determine if a specific stem cell line can be approved for use at UCSF.

Per California law, GESCR approval is required for any research involving human stem cells, with special provisions for the use of human embryos and oocytes to create stem cell lines. Depending on the source of funding, other laws and regulations may require GESCR review protocols using human embryos and oocytes, and the derivation and use of human embryonic stem cells (hESC), human embryonic germ cells, induced pluripotent stem cells (iPS) and human adult stem cells from any source, including somatic cell nuclear transplantation (SCNT).

As long as the materials and results cannot be traced to an individual donor, they can be handled in the same manner as other research materials and data. Contact the Environmental Health and Safety Office for assistance with material disposal.

In addition to GESCR, the IRB will review research involving human subjects.  Protocols that require both GESCR and IRB review are submitted in iRIS with a single protocol application. 

The Institutional Animal Care and Use Committee (IACUC) must review and approve all research using vertebrate animals. This review is not done through iRIS and must be coordinated through the IACUC office.

You will be asked if there is a conflict of interest when completing your submission.  If yes, a separate document must be completed and submitted with your application.

The requirement to obtain biosafety office approval is dependent upon the type of hESC work being performed. To determine if your hESC work requires biosafety committee approval you should contact the Environmental Health and Safety Office.

Transferring materials, whether within or outside an institution, is best accomplished with a Material Transfer Agreement (MTA) that respects the developer’s property rights, as applicable, in the materials and stipulates the terms and conditions under which the recipient may use the materials.  You will need to process the MTA in different ways depending on whether the Registry-derived materials are being transferred into, within or from UCSF.

The Office of Innovation, Technology & Alliances (ITA) is responsible for outgoing transfers of all UCSF proprietary materials other than human clinical specimens.  Stem cells and their derivatives are not considered by UCSF to be human specimens (e.g. tissue, urine, blood, etc.) because they are the result of inventive laboratory activities.  Investigators who want to send Registry-derived materials from UCSF to another UC Campus, university, government lab, or research institute should contact the ITA which will negotiate and sign the MTA. The ITA will also review requests for transfers by UCSF investigators of their Registry-derived materials to companies because different terms and conditions may apply. 

Researchers who want to receive Registry-derived materials from outside of UCSF also should contact the ITA.

As long as the materials and results cannot be traced to an individual donor, they can be commercialized in the same manner as other materials and data that comprise licensable subject matter. Contact the Office of Innovation, Technology & Alliances (ITA) early in the process. Do not make any public disclosures or transfer any materials outside of UC without first contacting the ITA, and do not wait until you start writing a manuscript or start planning a public presentation before engaging the ITA. Inventions can be disclosed to the ITA on forms available from the ITA webpage or by first contacting the ITA staff for a preliminary discussion.