The truth about stem cell science

MiResearch: Stem Cells 101 -- How is Stem Cell Research Regulated?

MiResearch: Stem Cells 101 -- How is Stem Cell Research Regulated?

The truth about stem cell science

The truth about stem cell science


ANN ARBOR, Mich. - University of Michigan experts are providing educational information to help Michigan citizens learn about the ethics, guidelines, and federal and state oversight that apply to all human stem cell research.

"Stem Cells 102," highlighted in an online video available at www.umich.edu/stemcell, provides accurate answers to those who seek the facts concerning embryonic stem cell research.
Embryonic stem cell research is considered by most scientists to be a very promising avenue for finding new treatments for incurable ailments such as juvenile diabetes and Parkinson's disease, to better understand inherited human disease, and to develop safer and more effective new drugs.
Embryonic stem cell lines are derived from discarded embryos that were created for fertility treatment, but are surplus or unsuitable for use in fertility treatment. However, Michigan is one of five states that have laws preventing the creation of new embryonic stem cell lines.
Through "Stem Cells 102," U-M stem cell scientist Sean Morrison, Ph.D., and Michigan Medical School Professor David Gordon, M.D., provide specific information about current issues regarding stem cell research, to clarify the law and the state of regulation.
Morrison directs the Center for Stem Cell Biology at U-M's Life Sciences Institute and is a faculty member at the U-M Medical School. Gordon directs the Center for Diversity & Career Development, and is a professor and associate dean, at the Medical School.
1. Embryonic stem cell research is one of the most regulated areas of medical research.
Embryonic stem cell research is extensively regulated by the Food and Drug Administration, Institutional Review Boards (IRBs) that are created and operated in accordance with federal law, and by Embryonic Stem Cell Research Oversight Committees that operate pursuant to guidelines from the National Academy of Sciences and the International Society for Stem Cell research.
Federal law (45 C.F.R. part 46) governs human subject research, including any research in which stem cells would be tested on patients as well as any research in which patients would donate embryos for the derivation of stem cell lines. That means that any stem cell research involving human subjects must be approved by IRBs, including the consent documents used to derive the lines and the methods employed to conduct the research, to ensure that the scientific goals are ethical and beneficial.
2. Additional layers of oversight are present in all federally funded research universities such as the University of Michigan.
Embryonic Stem Cell Research Oversight Committees (ESCRO committees) were created at research institutions, under guidance from the National Academy of Sciences, to oversee all aspects of pluripotent stem cell research, including all research conducted in laboratory dishes, and all research conducted in patients. This also provides an additional layer of oversight, beyond that provided by IRBs as noted above, over the derivation of stem cell lines. ESCRO committee approval is therefore required for all experiments performed with embryonic stem cells. These oversight committees (IRB and ESCRO) are composed of scientists, physicians, ethicists, lawyers, and members of the community.
3. Private research in companies is also regulated.
The U.S. Food and Drug Administration (FDA) regulates research done at private companies toward the development and testing of any medical product, and imposes similar regulations to ensure that such research is performed ethically. For this reason, companies generally establish their own in-house IRB committees to ensure that their research passes muster with the FDA.
Together, these mechanisms mean regulation of embryonic stem cell research, both at universities and at private companies, is extensive and comprehensive. Note as well that additional laws bearing restrictions on stem cell research are pending before Congress.
4. Current embryonic stem cell lines do not mirror the diversity in our society.
Currently, only certain embryonic stem cell lines, which were created on or before August 9, 2001, can be used for federally funded research. These embryonic stem cell lines do not reflect the diversity in American society. In fact, a surprisingly high fraction of the embryonic stem cell lines approved for use with federal funding arose from embryos obtained from a fertility clinic in Haifa, Israel.
This is key because one of the fundamental principles of clinical trials is that we test new medicines in a diverse patient population that mirrors the diversity in our society. For example, if we test new medicines only on people of a certain ethnic or racial makeup, there would be a risk that the medicines developed would not be as effective in other racial groups. This is because efficacy and side effects sometimes vary between racial or ethnic groups. 
Another reason why diversity in clinical research is key is that some inherited diseases are more prevalent in some populations. Examples of such genetic illnesses include Tay-Sachs among Ashkenazi Jews and sickle cell anemia, which is found more often among people of African descent. 
It is critical to enroll a diverse patient population so we have an opportunity to detect drugs that work for all ethnic groups. If embryonic stem cell research changes the future of medicine, we may be at risk of leaving certain groups out of that future by not studying embryonic stem cells from all ethnic backgrounds.
5. It is not true that stem cell research is unregulated or that unethical experiments could be conducted on patients.
A recent television ad compared stem cell research to the Tuskegee syphilis experiments, a tragic and universally condemned study conducted decades ago - before current federal laws on research involving humans were put in place. This comparison is utterly baseless and misleading. After the Tuskegee study was exposed to public scrutiny, the federal government put in place new research laws that explicitly prohibit unethical or harmful research. These laws require any stem cell research conducted in patients or in which patients donate embryos for the derivation of stem cell lines to be conducted ethically and safely under the oversight of IRBs or the FDA.
More information on stem cells can be found at www.umich.edu/stemcell and stemcells.nih.gov.
Additional resources:
Stem Cells 101: Five things you should know about stem cell research http://www2.med.umich.edu/prmc/media/newsroom/details.cfm?ID=696

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