George W. Bush Executive Order 13455, June 2007
On 20 January 2001, Republican George W. Bush was sworn in as the forty-third president of the United States, replacing Democrat William J. Clinton. During his eight years in office, Bush issued many executive orders, often altering previous policy. By signing Order 13435 on 22 June 2007, he changed how stem cell research would be performed in America. The Bush administration was influenced by its commitments to conservative ethical values when constructing this executive order; its goal was to expand stem cell research, but only in ways that did not involve the creation of, or damage to, a human embryo or fetus. This order was developed with the belief that pluripotent stem cells could be researched while still being respectful to human dignity and life. The four sections of Order 13435 provided strict guidelines for future stem cell research.
The first section, titled “Research on Alternative Sources of Pluripotent Stem Cells,” gives a description of Bush’s expectations in 2007 for the techniques and processes to be followed in the research. First, the Secretary of Health and Human Services would both perform and support research on how stem cells are isolated, derived, produced, and experimented with. Then, the secretary would collaborate with the Council on Bioethics to set standards for research ensuring that it is done for the purpose of increasing awareness of health issues to the benefit of society. Research could not be done on a human embryo created “for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.” The standards provided four other sources of embryos that could be used for research: dead embryos, embryos from altered nuclear transfers (ANT), embryos from single cell biopsy, and embryos from cellular programming. Along with this, the secretary would then produce a plan with the National Institutes of Health (NIH) that incorporated these standards and guided researchers to carry out projects in a responsible way. This included programs and techniques for research permissible by law and the proper course of action for requesting proposals and submitting applications. This order also added pluripotent stem cells to the Human Embryonic Stem Cell Registry, thus changing its name to the Human Pluripotent Stem Cell Registry. Finally, this section closed with the statement that by 31 December of every year, the Secretary would provide a statement to the president about research conducted and any new advancements made by the Department of Health and Human Services or NIH throughout that year.
The policy for research is described in section 2 of the order. This section states that stem cell research performed by the Department of Health and Human Services and NIH be done with the purpose of making medical advancements by creating a better understanding of diseases, conditions, and treatments. The procedures and cells used for this research were to abide by the rules set forth in section 1 of the order. The second section also states that any research supported by government funds should be performed in an ethical and moral way, meaning that no potential human life could be lost for the purpose of the research. Further, embryos and fetuses could not be bought, sold, or exploited, as they are still considered living beings. The main concern of this portion of the order was to distance research from controversial and immoral actions.
Section 3 addresses any confusion that might arise about specific interpretations of the first two sections of Order 13435. It clarifies the term “human embryo” while distinguishing what “harm” to an embryo denotes. In this specific order, embryo refers to “any organism…that is produced from fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.” Research done on embryos outside of the womb would abide by the same rules stated in both the 45 CFR 46 and the Public Health Service Act for a fetus within the uterus. Last, this section stated that nothing should be misinterpreted so that it could influence any other policies, rules, or regulations concerning stem cell research.
Section 4, the final section, is dedicated to general provisions for stem cell research. It states that the research done must be appropriate, consistent, and law abiding. Last. under no circumstances could anything having to do with the order be used by any party against the US, its departments, or individuals associated with them.
Order 13435 was put into effect immediately after it was signed by Bush at the White House. It was later revoked on 9 March 2009, after President Barack Obama signed Executive Order 13505, removing the barriers erected by the Bush administration. Bush’s executive order can now be found in Volume 72 of the Federal Register.
- National Institutes of Health. “Human Embryonic Stem Cell Policy Under Former President Bush (Aug. 9, 2001–Mar. 9, 2009).” Stem Cell Information. http://stemcells.nih.gov/policy/2001policy.htm (Accessed November 9, 2009).
- National Institutes of Health. “Plan for Implementation of Executive Order 13435: Expanding Approved Stem Cell Lines in Ethically Responsible Ways.” Stem Cell Information. http://stemcells.nih.gov/staticresources/policy/eo13435.pdf (Accessed December 6, 2009).
- US Government. “Executive Order 13435—Expanding Approved Stem Cell Lines in Ethically Responsible Ways.” Federal Register: (2007) 34951-53. http://edocket.access.gpo.gov/2007/pdf/07-3112.pdf (Accessed November 9, 2009).
- US Government. “Protection of Human Subjects.” Federal Register: (1991) https://irb.llnl.gov/appendices/Appendix03.pdf (Accessed November 9. 2009).
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