UCSD Guidelines for Human Embryonic and Human Pluripotent Stem Cell Research (updated January 7, 2013)

I. Introduction

These guidelines apply to any research or teaching use of human pluripotent 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, also known as ‘covered stem cell lines’ in the California Code of Regulations Title 17 section 100020. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. These guidelines also apply to use of human neural progenitor cells proposed for introduction into the brain of non-human animals at any state of embryonic, fetal, or postnatal development.

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 created as mandated by California Department of Public Health Guidelines for human Stem Cell Research Pursuant to Health and Safety Code §125119 and has responsibility for the review of research and teaching related to the derivation and use of human pluripotent Stem Cells. The UC San Diego ESCRO committee is administratively managed by the Human Research Protections Program (HRPP) and operates in conjunction with the Institutional Review Board (IRB) to ensure adequate review of research and teaching involving both pluripotent stem cells and protections of human subjects.

The Institutional Review Board - The Institutional Review Board (IRB) has responsibility for review and approval of research projects 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 projects for human pluripotent Stem Cell Research involving animal subjects conducted under UCSD’s institutional assurance.

III. Guidelines

A. Policies and Procedures - UCSD activities involving human pluripotent Stem Cells 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 pluripotent stem cell research from the National Academies of Science, National Institutes of Health (NIH), National Research Council Institute of Medicine (NRC IOM) 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.

B. Review Requirements - Projects involving the use of human pluripotent Stem Cells (both federally and non-federally funded) as defined above are subject to the review and approval of the ESCRO and IRB Committees prior to initiation of research or teaching. The Committees 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 pluripotent Stem Cells involving animal subjects must also be reviewed and approved by the UCSD IACUC prior to initiation of the study;
  • Research involving human subjects that seek to derive pluripotent cell lines must also be reviewed and approved by the UCSD IRB prior to initiation of the study;
  • Receipt, use, and disposal of human pluripotent Stem Cells must be in compliance with Environmental, Health and Safety requirements;
  • Research that intends to introduce human neural progenitor cells into the brain of non-human animals at any state of embryonic, fetal, or postnatal development must be reviewed and approved by the UCSD ESCRO and IACUC prior to initiation of the study.

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. Transfer of Materials - Receipt of human pluripotent 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 pluripotent Stem Cell materials must comply with campus purchasing policies. Any UCSD generated or modified human pluripotent 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.

E. Derivation - Derivation of new human pluripotent Stem Cell lines or human gametes, zygotes, embryos, stem cell, or pluripotent lines for the purpose of publication or external sharing will require ESCRO Committee review.

F. Banking – The IRB is responsible to review requests to establish banking of human gametes, zygotes, embryos, stem cells or pluripotent lines for the purpose of external sharing and usage.

G. 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.

H. Funding Sources

Separating Costs and Materials - Federal resources may be used only to support hESC projects using NIH Registry hESC lines in accord with the NIH guidelines and laws for use of federal funds for research. 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 stem cell lines that are not listed on the NIH human Embryonic Stem Cell Registry or Other Research Not Eligible for NIH Funding 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 stem cell lines that are not listed on the NIH human Embryonic Stem Cell Registry and Other Research Not Eligible for NIH Funding may not be conducted using personnel, supplies or other resources funded by federal monies. Investigators and departments conducting such research with non-Registry 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.

I. Information/Training - Research personnel with responsibilities for research using human pluripotent Stem Cells should have applicable information and training in stem cell research, policy, and ethics.

J. 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 or teaching involving human pluripotent Stem Cells will be responsible for having a defined process to periodically monitor research related activities, and prevent 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. The Institutional Official will formally appoint the ESCRO Chairperson to a renewable two-year term. Committee membership will be adjusted as necessary to meet all relevant state and federal regulations and any other nationally accepted guidelines. The ESCRO Chairperson will formally appoint the members of the ESCRO committee.

B. Committee Responsibilities – The ESCRO Committee is responsible for oversight of campus research and teaching related to the use of human pluripotent Stem Cells.

Specifically, the Committee is responsible for the following:

  • Reviewing and approving the ethical and scientific merit of human pluripotent Stem Cell research projects 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 pluripotent 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 pluripotent Stem Cell research conducted at the institution;
  • Advising investigators regarding additional institutional reviews required for their projects (i.e., review by IRB, IACUC, Bio-Safety Committee, Radiation Safety Committee, etc.);
  • Reminding investigators of institutional requirements for education and ethics training of researchers involved in human pluripotent Stem Cell research;
  • Disseminating any changes in the UCSD Guidelines for Human Embryonic and Human Pluripotent Stem Cell Research to UCSD investigators and other personnel.

V. Human Embryonic Stem Cell Review Process

The review process for human pluripotent Stem Cell research will be in accordance with existing campus procedures for IRB approval. The investigator is responsible for initiating both ESCRO and IRB reviews by submitting a single application to the IRB. At their discretion, the IRB may expedite review. IRB will obtain the required ESCRO Committee approval for research or teaching use of human pluripotent 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 and will be issued to the investigator by IRB. For extramurally funded projects, 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 UC San Diego Policies

VII. References

VIII. Frequently Asked Questions

IX. Other Research Not Eligible for Federal Funding

    NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09), otherwise known as the Dickey Amendment.

    Research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not eligible for NIH funding.