Stem Cell Policy
On March 9, 2009, President Barack Obama issued Executive Order (EO) 13505, entitled Removing Barriers to Responsible Scientific Research Involving Human Stem Cells that reversed the limitations on federally funded human embryonic stem cell (hESC) research to lines created before August 9, 2001. The executive order did not permit the creation or destruction of human embryos using federal funds and also called for the NIH to issue a new policy for management of this within 120 days.
The new NIH “Guidelines for Human Stem Cell Research” were released in final form on July 7, 2009 (Fed Register 74, No. 128, pages 32170-32175, July 7, 2009). Those guidelines were based on the National Academies of Sciences recommendations and contained criteria for hESC line inclusion that were much more strict than the criteria employed at the time of approval of the “Bush hESC lines”. As of June 14, 2012, 163 hESC lines had been approved by the Advisory Committee to the [NIH] Director for inclusion in the NIH human ESC Registry.
The March 9, 2009 Executive Order changed the way the National Institutes of Health (NIH) can support and conduct human stem cell research. The Health and Human Services Secretary is required to review existing NIH and other widely recognized guidelines on human stem cell research and issue new NIH guidance within 120 days of the date of the order.
The EO also revokes two items:
- The presidential statement of August 9, 2001.
- Executive Order 13435 of June 20, 2007. This Executive Order simply expanded the possible cell lines that could be entered into the Bush registry. None were ever added as a result.
For More on the Executive Order:
- See President Obama's speech on the White House Web site
- Compare the Obama administration's policy to the Bush administration's and Nebraska law
Nebraska's History on stem cell research
In 2000, the President of the University of Nebraska, L. Dennis Smith, Ph.D., established a committee to develop guidelines for embryonic stem cell (ESC) research conducted by the University of Nebraska. The resulting recommendations, adopted by the Board of Regents in 2001, required the university to follow federal guidelines, among other things. Therefore, when President Bush restricted the use of federal funds for ESC research to stem cell lines created prior to August 9, 2001, the university was also limited to using the “Bush” stem cell lines. UNMC established an Embryonic Stem Cell Research Oversight (ESCRO) committee to review any research proposals in this area. Current research in this area is still reviewed by this group.
The Nebraska Legislature has struggled with embryonic stem cell research legislation for many years, but no legislation was enacted until a compromise was reached in 2008. The compromise was the Stem Cell Research Act (LB 606).
LB 606
One of the major accomplishments of the 2008 session of the Nebraska Legislature was the passage of LB 606, a compromise bill pertaining to the human embryonic stem cell research being done at UNMC as well as the use of somatic cell nuclear transfer (SCNT).
LB 606 will allow UNMC researchers to continue to do research on human embryonic stem cells using federally approved cell lines in university facilities. However, under the provisions of LB 606, no state funds and facilities can be used to destroy or create an embryo for the purpose of research.
In relation to research involving human embryonic stem cell lines, LB 606 would:
- Allow UNMC to do research with public and private funding on human embryonic stem cell lines as long as the cell lines were developed elsewhere; and
- Allow UNMC to do research with public and private funding on SCNT lines as long as the lines were developed elsewhere.
The bill would not:
- Alter the Board of Regents' policy that allows UNMC scientists to use only federally approved stem-cell lines;
- Affect the Board of Regents' policy that prohibits University of Nebraska scientists from conducting SCNT research;
- Restrict human embryonic stem cell line creation or research done using private money and private facilities; and
- Restrict SCNT cell line creation or research done using private money and private facilities.
LB 606 encourages scientists to pursue research projects using non-embryonic stem cells rather than embryonic stem cells. Up to $500,000 in state tobacco settlement funds will be set aside in matching funds each year for non-embryonic stem cell research projects with no single institution in the state eligible to receive more than 70 percent of the funds.
As it now stands, the Federal law, which does not permit use of federal funds to support the creation or destruction of embryos or participating in cloning, is parallel to the Nebraska law with respect to use of state resources for the same hESC activities. The Board of Regents policy requiring the University of Nebraska be compliant with federal policy in this area is fully aligned with federal and state laws.
The University of Nebraska Medical Center developed a Regenerative Medicine Initiative in 2010 to bring together investigators and recruit new faculty in order to take advantage of the many opportunities this area offers for research and clinical development. As part of that effort, investigators at UNMC will continue ongoing work with many kinds of stem cells, all of whom strictly adhere to the federal and state guidelines and laws.