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University of Michigan
Policy on
Research with Human Embryonic Stem Cells
May 2005
- Cell lines & UM procedures
- Policy
Cell lines & procedures for obtaining cells
On August 9, 2001, President George W. Bush announced that federal funds may be awarded for research using human embryonic stem (ES) cell lines that meet certain criteria:
- The stem cell lines must have been derived from an embryo that was created for reproductive purposes;
- The embryo was no longer needed for these purposes;
- Informed consent must have been obtained for donation of the embryo;
- No financial inducements were provided for donation of the embryo.
Such research is now eligible for federal funding as long as the derivation process (which commences with the removal of the inner cell mass from the blastocyst) was initiated prior to 9:00 p.m. EDT on August 9, 2001.
As announced on November 7, 2001, the National Institutes of Health (NIH) has created a Human Embryonic Stem Cell Registry that originally listed 72 human embryonic stem cell lines (at varying stages of development) that meet the above eligibility criteria. As described at the web site http://escr.nih.gov, 22 cell lines are currently available from the indicated organizations:
- BresaGen, Inc., Athens, Georgia
- Cellartis AB, Goeteburg, Sweden
- ES Cell International, Melbourne, Australia
- MizMedi Hospital - Seoul National University, Seoul, Korea
- Technion University, Haifa, Israel
- University of California, San Francisco, California
- Wisconsin Alumni Research Foundation, Madison, Wisconsin
Obtaining cell lines
For NIH-funded investigators to gain access to the above human embryonic stem cell lines on the Human Embryonic Stem Cell Registry, a University Material Transfer Form [PDF] must be completed and a material transfer agreement must be negotiated with the source institution by the University's Division of Research Development and Administration (DRDA). Source-specific intellectual property restrictions may apply. In some instances, once one investigator at the University of Michigan has completed an MTA, additional investigators may only need to complete a "letter of agreement" with the provider to facilitate the transfer.As described in an earlier notice of August 24, 2000 entitled "NIH Guidelines for Research Using Human Pluripotent Stem Cells," the NIH has never placed restrictions on federally funded research using stem cells from human adult cells or umbilical cords. Moreover, there are no restrictions on privately funded research using human stem cells from either embryos or adult cells so long as no federal support is used as more specifically set forth in Section D.
The NIH guidelines vest the Institutional Review Board with responsibility for reviewing the ES cell derivation protocol and proposed use of the ES cells to assure conformity with the principles set forth in the guidelines, including any relevant amendments or revisions thereto. At present, the following conditions apply:
- Embryos may be secured only from fertility clinics and must no longer be needed for that purpose;
- Embryos must not be purchased;
- There must be no incentives to create embryos solely for the purposes of research;
- Informed consent must have been obtained for donation of the embryo;
- There must have been no financial inducements for donation of the embryo;
- Privacy and confidentiality provisions to protect the donor must be in place.
Under current Michigan law (MCL 333.2685), researchers within the State cannot use live embryos (e.g. discarded, pre-implanted embryos from fertility clinics) to derive embryonic stem cell lines.
University of Michigan Policy
UM oversight of federally-funded research with human ES cells will conform to the updated NIH policy of August 9, 2001, which limits federally-funded research to ES cell lines found in the NIH Human Embryonic Stem Cell Registry. The University will apply State law and the objectives of the earlier NIH guidelines of August 24, 2000, to the oversight of non-federally funded research. This policy supercedes the Interim Policy approved on January 20, 2001. This policy complies with all federal, state, and local statutes and regulations.
Charge to the Embryonic Stem Cell Research Oversight (ESCRO) Committee [pdf]
- Institutional Review Board Roles
- A.1. For research involving most in vitro uses of one or more of the lines listed in the NIH Registry, IRB approval is not required since the derivation of the lines listed already meets established guidelines and the research is considered exempt. Research involving nuclear transfer to ES cells that does not create a live embryo and any in vivo use of human ES cells does require IRB approval.
- A.2 The IRB will not approve a proposal for human reproductive cloning. (See note) The IRB will not approve a proposal to derive an ES cell line that would substantially jeopardize the life or health of a live embryo.
- A.3 For non federally-funded research involving the use of human ES cell lines that are not listed in the NIH Registry, full IRB review is required to ensure that the derivation protocol, including the donor consent process, complies with State law and the objectives of the NIH guidelines of August 24, 2000.
- A.4. With respect to research involving the use of human ES lines not included in the NIH registry, the IRB may place reasonable reliance on reviews of derivation protocols approved by other IRBs.
- A.5. The IRB shall conduct periodic reviews of proposed non-exempt research involving human ES cells (both federally- and privately funded) in light of the objectives of the NIH guidelines of August 24, 2000 and the policy statement of August 9, 2001, and list of ineligible research. For research involving cell lines not listed on the NIH Registry, the review will include privacy and confidentiality issues.
- A.6. For research involving human ES cell lines not listed in the NIH Registry, the legal advisors to the IRB shall review any proposed use and protections of ES cells in light of all federal, state, and local laws and regulations. Michigan law prohibits cloning to create a live embryo or use of a live embryo to derive ES cell lines. Researchers may, however, make use of ES cell lines derived elsewhere in accordance with NIH guidelines.
- Material Transfer and Research Agreements
- B.1. No agreements to transfer ES cells into or out of the University shall include the purchase of such cells. Reasonable costs of handling, transportation, processing, preservation, quality control and storage of ES cells are permitted and do not constitute "purchase." All costs associated with the acquisition of ES cells shall be clearly documented on the University related budget information provided by the Principal Investigator/Requester (e.g., Proposal Approval Forms [PAFs] or Material Transfer Forms [MTFs]). The University of Michigan Division of Research Development and Administration (DRDA) shall retain records on transfer costs for ES cells and maintain information on all ES cell transfers. If intra-University sharing of ES cells is permitted under an agreement, no intra-University sharing of ES cell lines shall include payments above and beyond reasonable costs of handling, transportation, processing, preservation, quality control and storage of ES cells.
- B.2. The University Material Transfer Form [MTF] or Proposal Approval Form [PAF] will record IRB approvals as applicable. No agreement for ES cells that are not listed in the NIH Registry will be signed on behalf of the University without an IRB approval number and date.
- Intellectual Property Considerations
- C.1. In determining whether or not to utilize either human ES cells lines listed on the NIH Registry or ES cells from other sources, Investigators should consider carefully the potential intellectual property restrictions which may limit the commercialization or other uses or distribution of results and materials generated by research involving these lines. Where such restrictions exist, in addition to standard institutional approvals, approval of the relevant Department Chair/Unit Head and Dean to enter into the agreement may be required when appropriate.
- Personnel and Equipment
- D.1. This policy allows faculty and staff with portions of their salaries paid with federal funds to conduct non federally-supported human ES cell research (involving lines not listed in the NIH Registry) during time that is uncommitted to federal projects. Conversely, faculty and staff whose salaries are solely supported by federal funds are restricted from the conduct of research involving cell lines not listed in the NIH Registry (this includes faculty whose effort is paid solely from Veterans Administration funds).
- D.2. No federal awards may be reprogrammed into human ES cell research not allowable by NIH policy.
- D.3. No research equipment for which the federal government currently holds title may be used for human ES cell research using cell lines not on the NIH Registry. (The terms of the award agreement apply, but generally, the title to equipment purchased with sponsored funds vests with the institution at acquisition or passes from the sponsor to the research institution at the close of the sponsored project.)
- D.4. No post-doctoral or graduate trainees with stipends paid solely from federal funds may participate in human ES cell research using cell lines not on the NIH Registry.
- D.5. Privately funded human ES cell research involving cell lines not listed on the NIH Registry may be conducted within laboratories and facilities in which the conduct of federal research also occurs so long as the conditions in D.1., D.3., and D.4., are met.
Note: Michigan Statute (MCLA 333.16274 and 750.430a) prohibits "human cloning" but does not prohibit other scientific research or cell-based therapies.
"Human cloning" means the use of human somatic cell nuclear transfer technology to produce a human embryo.
"Human embryo" means a human egg cell with a full genetic composition capable of differentiating and maturing into a complete human being.
"Human somatic cell" means a cell of a developing or fully developed human being that is not and will not become a sperm or egg cell.
"Human somatic cell transfer" means transferring the nucleus of a human somatic cell into an egg cell from which the nucleus has been removed or rendered inert.
Michigan Statute (MCLA 333.2685) states that a live human embryo shall not be used for non-therapeutic research. Michigan Statute (MCLA 333.2688) allows the use of a deceased embryo with maternal consent.