University of Minnesota (University) researchers may conduct research for therapeutic purposes using human embryos or embryonic stem cells (embryonic research) only in accordance with applicable federal and state laws and regulations, University policies and procedures and the decisions of the University of Minnesota Institutional Review Board (IRB).
Researchers who wish to use federal funds for embryonic 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 the embryos.
No federal funding may be used, either directly or indirectly, to support human embryonic stem cell research with federally unapproved hESC lines or for research that involves more than minimal risk to the embryos. The University extends this same funding prohibition to the use of funds from the State of Minnesota.
Studies involving human embryos or embryonic stem cell lines ineligible for federal or state funding must be registered with the Office of Regulatory Affairs (ORA) in the Office of the Vice President for Research and will be subject to oversight by ORA. These registered studies must have IRB approval, follow the necessary accounting standards and use only private funding.
Direct costs associated with a registered study must be charged to a private source of funding. A registered 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.
Exclusions
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 procedures to this policy do not apply to research using federally approved human embryonic stem cell lines or research that involves no more than minimal risk to the embryos.
Research on human embryos or embryonic 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. This policy is intended to inform and assist University researchers who wish to conduct embryonic research for therapeutic purposes, while at the same time assuring that all such research conducted at the University meets legal, policy and funding requirements.
There is no form for this policy.
- Approved Human Embryonic Stem Cell Line
- A 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
- Human Embryonic Stem Cell (hESC)
- Cell derived from the inner cell mass of human embryonic cells that have not yet become differentiated. Human embryonic stem cells have the potential for prolonged growth in culture and retain the potential to differentiate into one or more cell types.
- 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 Review Board (IRB)
- Committee that has been formally 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 embryonic stem cells that might lead to therapies in the future.
- Research Involving No More than Minimal Risk to Embryos
- Research where: (a) 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 (b) 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
- A cell with the potential for prolonged undifferentiated growth, but which retains the potential to differentiate into one or more cell types.
- Stem Cell Line
- If they are cultured properly, embryonic 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.
- Unapproved Human Embryonic Stem Cell Line
- 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
- Prepare proposal budget. Disclose intended use of federally unapproved hESC or research involving more than minimal risk to human embryos. Obtain IRB approval. Attend training session.
- Project Personnel (co-investigators, laboratory staff, student workers)
- Attend training session.
- Department Head
- Attend training session.
- Department Administrator and Accounting Personnel
- Attend training session. When using ISO, verify that rate does not include federal funds. When preparing financial transactions, include complete documentation. Notify Sponsored Projects Administration of changes to project.
- Accounting Services
- Identify ISOs that include federal funds in their rates and develop alternative rate if necessary.
- Sponsored Projects Administration
- Obtain information about the proposed project. Register project with the Office of Regulatory Affairs. Review project records during project period. (Ass't Director of F&A Costs). Schedule and conduct training.
- Institutional Review Board
- Route applicable forms to Sponsored Projects Administration. Confirm education status of project personnel before approving IRB application.
- Sponsored Financial Reporting
- Notify the Office of Regulatory Affairs when the project terminates.
- Office of Oversight, Analysis, and Reporting
- Perform transaction reviews.
- Office of Regulatory Affairs
- Register 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.
- 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.
There is no FAQ for this policy.
- Effective:
- December 2003
-
To obtain a copy of a historical policy,
e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.
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