UCSD Guidelines For Human Embryonic Stem Cell Research

I. Introduction

These guidelines apply to any research or teaching use of Human Embryonic Stem Cells, defined for the purpose of this document as 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 includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin.

Such activities at the University of California, San Diego (UCSD) must be conducted in compliance with state and federal regulations and compliance requirements developed by UCSD.

II. Review Committee Descriptions

Embryonic Stem Cell Research Oversight Committee - The Embryonic Stem Cell Research Oversight (ESCRO) Committee is an advisory body to the Vice Chancellor for Research and has responsibility for the review of issues related to the derivation and use of Human Embryonic Stem Cells.

The Institutional Review Board - The Institutional Review Board (IRB) has responsibility for review and approval of research protocols for human stem cell research involving human subjects conducted under UCSD’s institutional assurance.

The Institutional Animal Care and Use Committee - The Institutional Animal Care and Use Committee (IACUC) has responsibility for review and approval of research protocols for Human Embryonic Stem Cell Research involving animal subjects conducted under UCSD’s institutional assurance.

III. Guidelines

A. Policies and Procedures - UCSD activities involving Human Embryonic Stem Cell research will be conducted in accordance with applicable state and federal regulations, including any restrictions on the use of federal funds, and relevant UC and UCSD policies and procedures. Relevant policies and decision-making will be informed by the best available information, including University of California (UC) guidance and the Guidelines for Human Embryonic Stem Cell Research from the National Academies of Science, National Research Council Institute of Medicine and the California Institute for Regenerative Medicine (CIRM).

B. Review Requirements - Proposals involving the use of Human Embryonic Stem Cells (both federally and non-federally funded) as defined above are subject to the review and approval of the ESCRO Committee prior to initiation of research or teaching. The ESCRO Committee may request additional documentation in order to facilitate such review. Such reviews will occur in coordination with other campus reviews.

Further, in accordance with existing campus policies:

  • Research with Human Embryonic Stem Cells must also be reviewed and approved by the UCSD IRB prior to initiation of the study;
  • Research with Human Embryonic Stem Cells involving animal subjects must also be reviewed and approved by the UCSD IACUC prior to initiation of the study;
  • Receipt, use, and disposal of Human Embryonic Stem Cells must be in compliance with Environmental, Health and Safety requirements.

C. Transfer of Materials - Receipt of Human Embryonic Stem Cell materials must comply with the Office of Contract and Grant Administration (OCGA) Material Transfer Agreement (MTA) requirements, or other written acknowledgement. Purchased Human Embryonic Stem Cell materials must comply with campus Purchasing policies. Any UCSD generated or modified Human Embryonic Stem Cell materials to be transferred off campus for use by others must comply with the Office of Technology Transfer and Intellectual Property Services (TechTIPS) requirements for an MTA or license agreement. Offices handling such transactions will also be responsible for compliance with ESCRO requirements for assuring prior approval and providing information for campus tracking of such transactions, as appropriate.

D. Derivatives and Banking - Derivation of new Human Embryonic Stem Cell lines or banking of human gametes, zygotes, embryos, or stem cell lines for the purpose of external sharing and usage will require ESCRO Committee review, and at the discretion of the VC Research additional ad hoc review and approval.

E. Conflict of Interest - Conflict of interest disclosures must be filed with the Conflict of Interest (COI) office as required. Such disclosed conflicts will be evaluated and managed on a case-by-case basis. The COI office will provide information as appropriate to the ESCRO Committee, similar to the process for the IRB.

F. Funding Sources

Separating Costs and Materials - Federal resources may not be used to support projects on non-registry hESC lines.  For more information, please see "Separating Costs and Materials for Research on Non-Registry hESC Lines from Those for Federally Funded Research" located at http://escro.ucsd.edu/separatingcosts.html.

Equipment - Research involving Human Embryonic Stem Cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted using equipment exclusively or partially acquired with federal funds, unless (1) the federal contract or grant supporting the equipment purchase has been completed (including all of its competitive segments), (2) UCSD has submitted the equipment inventory report required by the award and at least 120 days have elapsed from the date the report was submitted, (3) the federal government has not invoked its right to transfer the equipment within the 120 day period; and (4) UCSD retains title to the equipment without restriction.

Other resources - Research involving Human Embryonic Stem Cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted using personnel, supplies or other resources funded by federal monies. Investigators/departments conducting such research with non-federally approved cell lines are responsible for assuring that expenses for such projects are appropriately segregated and charged to a non-federal funding source. Extreme care must be used in allocating salary costs and in monitoring and allocating time and effort of all employees working on such projects to assure that split-funded employee costs are allocated to the appropriate fund source. The use of daily logs or similar supplemental records is an acceptable documentation method for salary costs.

G. Information/Training - Research personnel with responsibilities for research using Human Embryonic Stem Cells should have applicable information and/or training in stem cell research, policy, and ethics.

H. Audit/Compliance - The campus program for ensuring compliance with relevant State and Federal regulations, and UC and UCSD policies and procedures will consist of both monitoring by department management and independent audit. Each department with research involving Human Embryonic Stem Cells will be responsible for having a defined process to periodically monitor research related activities, and prevent and/or correct potentially non-conforming behavior. Additionally, all procedural and financial research aspects will be subject to independent review by UCSD Audit and Management Advisory Services.

IV. Formation and Responsibilities of the ESCRO Committee

A. Committee Membership - The ESCRO Committee will include UCSD representatives with the expertise necessary for scientific and ethical review of research and teaching uses of hESC research. Committee membership will be adjusted as necessary to meet all relevant state and federal regulations and any other nationally accepted guidelines. The VC Research will formally appoint the members of the ESCRO committee for one year terms.

B. Committee Responsibilities – The ESCRO Committee is responsible for oversight of campus issues related to the use of Human Embryonic Stem Cells.

Specifically, the Committee is responsible for:

  • Reviewing and approving the ethical and scientific merit of Human Embryonic Stem Cell research protocols in coordination with review of the appropriate boards (e.g., IRB, IACUC) and communicating determinations of such reviews to the appropriate boards;
  • Identifying ongoing Human Embryonic Stem Cell research and confirming that such research is in compliance with accepted campus practices or referring specific issues to the administrative or departmental office for appropriate resolution;
  • Recommending actions, guidelines, and policies as needed to the VC Research to ensure compliance and the ethical conduct of research involving Human Embryonic Stem Cells; this includes, but is not limited to derivation of new human stem cell lines, banking of human stem cell lines, and registries of Human Embryonic Stem Cell research conducted at the institution;
  • Advising investigators regarding additional institutional reviews required for their projects (e.g., review by IRB, IACUC, Bio-Safety Committee, Radiation Safety Committee, etc.).
  • Facilitating the education and ethics training of investigators involved in Human Embryonic Stem Cell research;
  • Developing a formal interface with the Communications Office for assisting with public inquiries regarding Human Embryonic Stem Cell research.

V. Human Embryonic Stem Cell Review Process

The workflow/review process for processing Human Embryonic Stem Cell research will be in accordance with existing campus procedures, with the exception of the additional review required by the ESCRO Committee for research or teaching use of Human Embryonic Stem Cells. A project may not be initiated without ESCRO Committee and IRB approval. Approval by the IRB will be concurrent with or following approval by the ESCRO Committee. The investigator is responsible for initiating these reviews by forwarding a copy of the proposal to both the ESCRO Committee and the IRB. For extramurally-funded proposals, OCGA will verify ESCRO Committee and IRB approval prior to acceptance of an award. For projects with other funding sources, the department and investigator are responsible for obtaining ESCRO Committee and IRB review and approval before beginning the project.

VI. Related Policies

VII. References

VIII. Frequently Asked Questions