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The Truth About Stem Cell Science
Date:10/27/2008

g 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 IRBs must approve any stem cell research involving human subjects, 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 c
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SOURCE University of Michigan Health System and News andInformation
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