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).
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.