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Week Ending June 22, 2006

Executive Order 13435 Expanding approved stem cell lines in ethically responsible ways

The President, in support of the use of pluripotent stem cells. Pluripotent stem cells are derived from sources such as umbilical cord blood and are seen by the President as a viable alternative to stem cells derived from fetuses or fetal cells developed but not used by fertility clinics.

The Order authorizes the Secretary of Health and Human Services to conduct and support research on the isolation, derivation, production and testing of stem cells that are capable of producing all or almost all of the cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, The cells must be derived without creating a human embryo for research purposes or by destroying, discarding, or subjecting to harm a human embryo or fetus.

The Secretary must produce a plan within 90 days that includes such mechanisms as requests for proposals and applications, program announcements and other means to implement the plan. Specifically, the plan must reflect a determination of the extent to which specific techniques may require additional basic or animal research to ensure that any research involving human cells using the techniques is clearly consistent with the standards established in the order (cells must be derived without creating a human embryo for research purposes or by destroying, discarding, or subjecting to harm a human embryo or fetus.)

The plan must prioritize research with the greatest potential for clinical benefit and will take into account techniques outlined by the President’s Council on Bio-ethics and any other techniques provided they meet the standards of the Order.

The database of existing stem cells is to be renamed from the “Human Embryonic Stem Cell Registry to the “Human Pluripotent Stem Cell Registry. The Registry will include stem cell lines that meet the Order’s standards.

On December 31^st each year the Secretary will report to the President on activities carried out under this Order including a description of research and other developments regarding pluripotent stem cell science.

The Order specifies as it’s purpose:

“to direct the Department of Health and Human Services, including the  National Institutes of Health, 

to intensify peer reviewed research that may result in improved understanding of or treatments for 

diseases and other adverse health conditions, and (ii) to promote the derivation of human pluripotent 

stem cell lines from a variety of alternative sources while clearly meeting the standard set forth in” the Order.

“it is critical to establish moral and ethical bboundaries to allow the Nation to move forward vigorously 

with medical research, while also maintaining the highest ethical standards and respecting human life 

and human dignity--the destruction of nascent life for research violates the principle that no life should 

be used as a mere means for achieving the medical benefit of another”

“human embryos and fetuses, as living members of the human species, are not raw materials to be 

exploited or commodities to be bought and sold”

“the Federal Government has a duty to exercise responsible stewardship of taxpayer funds, both 

supporting important medical research and respecting ethical and moral boundaries.”

“For purposes of this order, the term ``human embryo'' shall mean any organism, not protected 

as a human subject under 45 CFR 46 as of the date of this order, that is derived by fertilization, 

parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.”

“For purposes of this order, the term ``subjecting to harm a human embryo'' shall mean subjecting 

such an embryo to risk of injury or death greater than that allowed for research on fetuses in utero 

under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) 

as of the date of this order.

“Nothing in this order shall be construed to affect any policy, guideline, or regulation regarding 

embryonic stem cell research, human cloning by somatic cell nuclear transfer, or any other research 

not specifically authorized by this order, or to forbid the use of existing stem cell lines deemed eligible 

for other federally funded research in accordance with the presidential policy decision of August 9, 2001, 

for research specifically authorized by this order.

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