Printed on: 10/21/2020. Please go to http://policy.umn.edu for the most current version of the Policy or related document.
University of Minnisota  Administrative Policy

Conducting Research with Human Embryos or Pluripotent Stem Cells

Responsible University Officer(s):
  • Vice President, Research
Policy Owner(s):
  • Associate Vice President for Research
Policy contact(s):
  • Greg Park
Date Revised:
Apr 20, 2020
Effective Date:
Dec 1, 2003

Policy Statement

This policy applies to research with: 1) human embryos; 2) human embryonic stem cells and cell lines, whether derived from IVF embryos or through somatic cell nuclear transfer (SCNT); 3) human induced pluripotent stem cells (iPS cells) or other sources of human pluripotent stem (hPS) cells that are intended to make or contribute to an embryo or a germ cell (oocytes or sperm); and 4) mixed human-animal entities containing cells derived from human embryos, human iPS or through human SCNT (“covered research”).

University researchers may conduct research using human embryos or human stem cells that does not constitute covered research provided they comply with applicable federal and state laws and regulations, and University policies and procedures. The Stem Cell Research Oversight (SCRO) Panel must review and approve all covered research, regardless of eligibility for federal funding, before the research begins. The Panel has authority to approve, require modifications to or disapprove proposed covered research, and to suspend or terminate approved covered research for serious non-compliance or unanticipated problems. When required by other University policies and federal regulations, researchers also must also obtain approval from the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and/or the Institutional Biosafety Committee (IBC).

The SCRO Panel will review the scientific merit and ethical justification of proposed covered research. As part of its review process, the SCRO Panel will determine which categories of proposed covered research require notification/minimal review versus full review and which will not be permitted at this time. The Office of Biotechnology Activities Oversight (OBAO) will maintain a complete record of all covered research, all human pluripotent stem cell lines derived during covered research, and all human pluripotent stem cell lines obtained by the University for covered research.

The Office of the Vice President for Research (OVPR) will oversee all covered research.

Researchers who wish to use federal funds for covered research must meet the requirements imposed under federal law to obtain and use federal funds for this purpose. Federal funds are allowable for research using only federally approved human embryonic stem cell (hESC) lines.

As per the NIH Guidelines for Research Using Human Stem Cells, no federal funding may be used, either directly or indirectly, to support the derivation of new hESC lines or research using hESC lines derived from any source other than excess in vitro fertilization embryos created for reproductive purposes. Federal funds may not be used for the creation of a human embryo or embryos for research purposes, or research that involves more than minimal risk to embryos. The University extends this same funding prohibition to the use of funds from the State of Minnesota.

Units must register ineligible research with the OBAO in the OVPR. Researchers conducting ineligible research are required to:

  • complete training provided by Sponsored Projects Administration,
  • follow the necessary accounting standards below, and
  • use only private funding (non-federal and non-state funds).

Units must charge direct costs associated with ineligible research to a private source of funding. Ineligible research must have in place a method of separating the costs of supporting the research so that any of the facilities and administrative (F&A) costs allocable to the ineligible research are excluded from the rates established and used to charge F&A costs to federal/state funded research. In addition, the principal investigator and the responsible laboratory administrator must carefully and consistently allocate all costs of the ineligible research to a private funding source, and include a note on each purchasing document that indicates that the purchased items will be used for federally unapproved hESC research or research that involves more than minimal risk to the embryos. Approvers must verify this note. Project personnel must notify Sponsored Projects Administration if ineligible research related to space, equipment, and personnel change (see related procedure).

Exclusion

This policy and its procedures do not apply to the use of embryos in non-experimental clinical care provided to patients undergoing reproductive treatments, the use of non-pluripotent human stem cells in research, or the use of human iPS or hPS cells for purposes other than making or contributing to an embryo, germ cell (oocytes or sperm), or mixed human-animal entity.

Reason for Policy

Research on human embryos or human stem cells holds the potential for treating a wide variety of diseases and disorders, including genetic diseases, tissue injuries and degenerative diseases, such as Parkinson's disease, heart disease and spinal cord injury. University researchers who wish to conduct this research must have the infrastructure necessary to do so in order to comply with legal, policy and funding requirements. Consistent with the Final Report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research, this policy provides an oversight system to assure the responsible conduct of this research at the University.

Procedures

Forms/Instructions

Appendices

Frequently Asked Questions

Contacts

Subject Contact Phone Email
Primary Contact(s) Gregory Park 612-625-9153 parkx479@umn.edu
Funding/Accounting Questions Associate VP for Research, Sponsored Projects Administration (SPA) 612-624-1648 612-624-4843
SPA Website
Regulatory Questions Gregory Park 612-625-9153 parkx479@umn.edu

Definitions

Approved Human Embryonic Stem Cell Line
An embryonic stem cell line that the federal government has approved for use in federally funded research. The list of cell lines is available at the NIH Stem Cell Registry, however federal funding is not restricted to these cell lines if hESC eligibility for NIH funding has been established through mechanisms described in the NIH Guidelines for Human Stem Cell Research (Section II (A) and (B)).
Human Embryonic Stem Cell (hESC)
A type of pluripotent stem cell derived from early stage human embryos, up to and including the blastocyst stage. hESCs are capable of dividing without differentiating for a prolonged period in culture and are known to develop into cells and tissues of the three primary germ layers.
Human Induced Pluripotent Stem Cells (iPS cells)
Somatic cells that have been reprogrammed to a pluripotent state through the expression of genes or proteins.
Human Pluripotent Stem Cells (hPS cells)
Cells with unlimited proliferation potential and a capability to differentiate into all tissues of an organism, but not alone capable of sustaining full organismal development.
Human Somatic Cell Nuclear Transfer (SCNT)
A technique that combines a human somatic cell nucleus to a human enucleated egg. SCNT is allowable for therapeutic purposes only.
Ineligible Research
Research with federally unapproved embryonic stem cell lines and/or research involving more than minimal risk to human embryos which cannot be supported, directly or indirectly, with federal funds or funds from the State of Minnesota.
Institutional Animal Care and Use Committee (IACUC)
Committee that has been designated as required by federal regulations to review and monitor research, teaching and service activities involving animals and to take appropriate steps to assure these activities meet legal and policy requirements for the humane care and use of animals.
Institutional Biosafety Committee (IBC)
Committee that has been designated by University Board of Regents policy to review research and teaching activities involving recombinant or synthetic nucleic acid molecules and other potentially hazardous biological agents and to take appropriate steps to assure these activities meet applicable safety requirements.
Institutional Review Board (IRB)
Committee that has been designated as required by federal regulations to review and monitor research involving human subjects and to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
Mixed human-animal entity
Human pluripotent cells introduced into a non-human vertebrate animal pre-gastrulation embryo.
Stem Cell
Cells with the ability to divide for indefinite periods in culture and to give rise to specialized cells.
Stem Cell Line
If they are cultured properly, human stem cells can grow and be propagated indefinitely. A stem cell line is a mass of cells descended from the original, sharing its genetic characteristics. Batches of cells can then be separated from the cell line and distributed to researchers.
Stem Cell Research Oversight (SCRO) Panel
Panel that has been designated, as recommended by the National Academies’ Guidelines for Human Embryonic Stem Cell Research, to review research involving human embryonic stem cells. The Panel also reviews proposed research involving human embryos and pluripotent stem cells as covered in this policy.
Unapproved Human Embryonic Stem Cell Line
Embryonic stem cell lines not eligible for NIH funding.
University Researcher
University faculty, staff, trainees and students and any other individual, regardless of appointment status, who performs research on behalf of the University that involves human embryos or embryonic stem cells.

Responsibilities

Principal Investigator
Obtain approval from SCRO panel for covered research. If required, also obtain approval from IRB, IACUC and/or IBC. For ineligible research, prepare proposal budget, attend training session, and handle lab space and materials in accordance with established procedures.
Project Personnel (co-investigators, laboratory staff, student workers)
For ineligible research, attend training session, and handle lab space and materials in accordance with established procedures.
Department Head
Attend training session for ineligible research.
Department Administrator and Accounting Personnel
Attend the training session for ineligible research. When using a recharge center or units conducting internal sales for project-related services, verify that rate does not include federal funds. When preparing financial transactions, include complete documentation. Notify Sponsored Projects Administration of changes to project.
Internal/External Sales Office
For principal investigators conducting ineligible research, identify a recharge center or units conducting internal sales that include federal funds in their rates and develop alternative rates if necessary.
Sponsored Projects Administration
Obtain information about the proposed ineligible research project. Notify the Research Compliance Office about projects. Review project records during project period. (Ass't Director of F&A Costs). Schedule and conduct training.
Stem Cell Research Oversight (SCRO) Panel
Review the scientific merit and ethical justification of proposed covered research and determine whether to approve, require modifications to or disapprove the research.
Office of Biotechnology Activities Oversight (OBAO)
Provide administrative support to the SCRO Panel. Register eligible research project at its start and deactivate project at its end. Review project records when project becomes active or deactivated and provide ongoing support of all oversight aspects of the project. Maintain a complete record of all covered research, all human pluripotent stem cell lines derived during covered research, and all human pluripotent stem cell lines obtained by the University for covered research. Confirm training status of project personnel involved in ineligible research before approving SCRO application. Notify RCO of approved projects.
Institutional Biosafety Committee (IBC)
Review proposed covered research that involves recombinant or synthetic nucleic acid molecules or other potentially hazardous biological agents
Institutional Animal Care and Use Committee (IACUC)
Review proposed covered research that also involves animals and determine whether proposed research meets IACUC requirements for care and use of animals.
Institutional Review Board (IRB)
Review proposed covered research that also involves interaction with/ identification of donors or clinical applications of human embryonic stem cells in patients and determine whether proposed research meets IRB requirements for protection of donors and patients as human subjects.
Research Compliance Office
Perform transaction reviews for ineligible research. Provide oversight of SCRO Panel and Administrative Support activities on a risk-based priority.
Office of the General Counsel
Provide advice to University researchers and administrators on the law, regulations and University policy requirements related to research with human embryos or federally unapproved human embryonic stem cell lines.

Related Information

History

Amended:
April 2020 - April 2020 - Comprehensive Review, Minor Revisions. Policy updated to improve the accuracy of wording. Title changed from "Conducting Research with Human Embryos or Embryonic Stem Cells" to "Conducting Research with Human Embryos or Pluripotent Stem Cells".
Amended:
October 2017 - Updated contact information, policy owner, and clarified roles.
Amended:
August 2015 - Comprehensive Review, Minor Revision.  Policy updated to reflect organizational changes, revisions to federal policies related to this type of research.
Amended:
December 2014 - Reference to A-21 changed to OMB Uniform Guidance Related Information.
Amended:
November 2008 - Clarified Statement, Reason, Definitions, Responsibilities and Procedures.
Effective:
December 2003

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