Conducting Research with Human Embryos or Embryonic Stem Cells
Responsible University Officer(s):
- Vice President for Research
- Associate Vice President for Research
- Greg Park
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 for therapeutic purposes using human embryos or human stem cells 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 research, and to suspend or terminate approved 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 research proposals. As part of its review process, the SCRO Panel will determine which categories of proposed research require notification/minimal review versus full review and which will not be permitted at this time. The Office of Biotechnology Activities (OBAO) will maintain a complete record of all human embryonic and human stem cell research conducted at the University and all human stem cell lines derived or obtained by University researchers which are covered by this policy.
The Office of the Vice President for Research (OVPR) will oversee all covered embryonic and stem cell research.
Researchers who wish to use federal funds for human stem cell research must meet the requirements imposed under federal law to obtain and use federal funds for this purpose. Federal funds are allowable only for research using federally approved human embryonic stem cell (hESC) lines or for research that involves no more than minimal risk to embryos.
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. The University extends this same funding prohibition to the use of funds from the State of Minnesota.
Units must register studies involving human embryos or human embryonic stem cell lines ineligible for federal or state funding 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 an ineligible study to a private source of funding. An ineligible study 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.
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 contributing to an embryo, germ cell, 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 "Guidelines for Human Embryonic Stem Cell Research" issued by the National Academy of Sciences, this policy provides an oversight system to assure the responsible conduct of this research at the University.
|Primary Contact(s)||Gregory Parkfirstname.lastname@example.org|
|Funding/Accounting Questions||Associate VP for Research, Sponsored Projects Administration (SPA)||612-624-1648||612-624-4843
|Regulatory Questions||Gregory Parkemail@example.com|
- 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 (Section II (A) and (B)).
- Human Embryonic Stem Cell (hESC)
- Cell derived from the inner cell mass of blastocyst stage human embryos that 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 as required by federal guidelines to review research and teaching activities involving recombinant DNA 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.
- Research for Therapeutic Purposes
- Research intended to develop new medical therapies and/or administer such therapies to patients/research participants or research in the basic science and biology/physiology of embryos or covered stem cells that might lead to therapies in the future.
- Research Involving No More than Minimal Risk to Embryos
- Research where:
- the risk to the embryo is no more than minimal, as determined by the IRB, and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means; or
- the purpose of the research is to meet the health needs of a particular embryo(s) and the embryo(s) will be placed at risk only to the minimum extent necessary to meet such needs.
- 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 national academy guidelines to review research involving human embryonic stem cells and to maintain a complete record of this research at the University. The Panel also reviews and maintains records of other research involving human embryos and human stem cells as set forth in this policy.
- Unapproved Human Embryonic Stem Cell Line
- Embryonic stem cell lines other than those approved by the federal government.
- 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.
- Principal Investigator
- Obtain approval from SCRO panel. 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 training session for ineligible research. When using ISO 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 ISOs that include federal funds in their rates and develop alternative rate 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 research involving human embryos and embryonic stem cells and determine whether to approve, require modifications to or disapprove the research. Maintain a complete record of all human embryonic and embryonic stem cell research conducted at the University and all human embryonic stem cell lines derived or obtained by University researchers. Confirm training status of project personnel involved in ineligible research before approving SCRO application. Notify RCO of approved projects.
- 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 oversight of all regulatory aspects of the project.
- Institutional Bio-safety Committee (IBC)
- Review proposed human embryonic research involving recombinant DNA or other potentially hazardous biological agents and determine whether proposed research meets IBC safety requirements.
- Institutional Animal Care and Use Committee (IACUC)
- Review proposed human embryonic research involving animals and determine whether proposed research meets IACUC requirements for care and use of animals.
- Institutional Review Board (IRB)
- Review proposed human embryonic research involving 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.
- Administrative Policy: Charging of Direct and Facilities and Administrative (Indirect) Costs
- OMB Uniform Guidance
- Research Subjects' Protection Programs
- National Institutes of Health, Office of Extramural Research
- NIH Stem Cell Registry
- October 2017 - Updated contact information, policy owner, and clarified roles.
- August 2015 - Comprehensive Review, Minor Revision. Policy updated to reflect organizational changes, revisions to federal policies related to this type of research.
- December 2014 - Reference to A-21 changed to OMB Uniform Guidance Related Information.
- November 2008 - Clarified Statement, Reason, Definitions, Responsibilities and Procedures.
- December 2003