sory Committee also updated the Guidelines in 2007 and 2008 to reflect the lessons learned by scientists and administrators around the country and to reflect changes in the science of stem cell research. Finally, the Advisory Committee organized or participated in several public workshops on key areas of concern, such as the medical risks of oocyte donation and the next steps toward translating bench science to clinical trials.

The inauguration of President Barack Obama in January 2009 led to a marked shift in federal policies on stem cell research. On March 9, President Obama issued Executive Order (EO) 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.” (Federal Register Volume 74, Number 46, pp. 10667-10668). President Obama’s EO stated that the “Secretary of Health and Human Services, through the Director of NIH [National Institutes of Health], may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” While leaving untouched the “Dickey-Wicker” amendment,1 which can only be changed by Congress and which effectively prohibits the use of federal funds to derive new human embryonic stem (hES) cell lines, the EO did rescind prior Executive branch policy. Specifically, the EO rescinded the previous policy that had restricted federal funding for hES cell research to in vitro work on lines derived before an earlier EO issued by President George W. Bush, by stating “The Presidential statement of August 9, 2001, limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.”

The EO issued by President Obama also called upon NIH to review its own existing guidance as well as other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and to develop and issue new NIH guidance for such research that is consistent with the EO’s call to support “responsible, scientifically worthy” stem cell research. Without the restrictions placed upon it by the previous administration, the NIH announced that it would begin a broader

1

The so-called “Dickey Wicker” amendment has been included in the annual federal appropriation for government-funded activities and has been interpreted to prevent the creation of new human embryonic stem cell lines using federal funds. For example, Section 509 of the Omnibus Appropriations Act 2009, enacted as Public Law 111-8) says:

None of the funds made available in this Act may be used for—(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFE 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).



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