Since the isolation of human embryonic stem cells by Dr. James Thomson in 1998, the federal government of the United States has struggled to create a standard human stem cell research policy. Much of the stem cell research debate is influenced by the competing moral and ethical arguments that continue to shape U.S. governmental policy in this scientific arena. Federal stem cell policy has wide implications and is not just limited to the stem cell research field. Much of the debate regarding stem cell research addresses the status of human embryos that are used in research.
With the advent of in vitro fertilization techniques and their growing use during the 1980s, the federal government became concerned with developing regulations for biotechnologies that use human embryos or embryonic tissue. Significant ethical and moral concerns arose over the potential for abuse of newly developed biotechnologies, and rising concern among many religious groups over the potential for fertilized embryos, viewed by many as sacred human lives, to be discarded and other ethical concerns led the federal government to consider and ultimately adopt comprehensive legislation. This legislation effectively banned federal funding of research conducted on human embryos. The Dickey Amendment, passed by Congress in 1995 and signed by President William Clinton in 1996, expressly forbade all federal funding for the creation of human embryos for the purpose of research or for any research that would result in the destruction of a human embryo. Since its passage, the amendment has been included in all of the U.S. Department of Health and Human Services, Department of Labor and the Department of Education appropriations, ensuring that the Dickey policy remains law.
The isolation of human embryonic stem cells in 1998 by Thomson represented an enormous new concern in the bioethics debate that was already raging. Politicians and government agencies struggled to create a uniform policy that adequately addressed issues raised by a concerned public. Because of the relative youth of the stem cell field, uniformity in scientific information was often not readily available or presented to the public.
Many of the original concerns discussed in regulating novel technologies such as in vitro fertilization surfaced again in the federal stem cell policy debate. Many conservative religious groups strongly argued that federal support of embryonic stem cell research would result in the destruction of many more human embryos and decrease the value of human life. Other groups also renewed concerns over the possible abuse of embryo manipulating technologies. It is important to note that many of these groups did not object to research conducted on adult human stem cells.
In contrast, many scientific groups argued that broad federal support for this relatively young field was necessary. Scientific groups touted the potential of stem cell research to yield potential cures to intractable illnesses, which warranted thorough consideration by the public. Many scientific and some business groups also argued that stringent regulation of stem cell research could stifle the field and damage the ability of the United States to maintain a leading role in a promising new scientific area.
CLINTON ADMINISTRATION PROPOSALS
In 1999 the National Bioethics Advisory Commission, which directly advised President Clinton, recommended federal legislation to permit harvesting of human embryonic stem cells from embryos that were “left over” from in vitro fertilization treatments. However, the panel explicitly noted that this option should only be available in the case that the harvesting of embryonic stem cells would not be the proximate cause of the destruction of the human embryo. By adding this restriction, the advisory commission hoped to maintain compliance with the Dickey Amendment, which had been previously signed into law by President Clinton.
The suggestions of the National Bioethics Advisory Commission were taken under advisement; however, a policy decision on the federal level was not made at this time, as the Clinton administration was drawing to a close. Much of the regulation of the stem cell field would be determined and administered by the next U.S. president, George W. Bush.
FEDERAL FUNDING GUIDELINES
After taking office, President George W. Bush was faced with the task of developing a comprehensive policy to regulate federal funding of stem cell research projects. The policy established by President Bush outlines a number of criteria that allow for federal funding in a limited number of circumstances. The current policies of the U.S. federal government do not restrict or limit federal funding of human adult stem cell research programs, with the most stringent regulation reserved for research regarding human embryonic stem cells.
President Bush’s policy implemented across all relevant federal agencies, such as the National Institutes of Health, establishes three primary criteria for the use of federal funds in embryonic stem cell research. The first criterion establishes that federal funds that are sought for embryonic stem cell research must be reserved for research that uses embryonic stem cell lines derived or isolated before 9:00 p.m., Eastern Standard Time, on August 9, 2001. The second criterion establishes that the embryonic stem cells that are being used in the course of research must have been derived from an embryo that was originally created for reproductive purposes but was no longer needed.
The final criterion directs that the egg and related embryonic stem cells extracted for research purposes must have been obtained with the full consent of the donor without any financial incentives. On the basis of these criteria, the National Institutes of Health have identified 71 individual stem cell lines developed from genetically different blastocysts (an early stage of embryonic development) that may be used in research and that receive federal funding. However, only 21 lines are considered viable.
OTHER FEDERAL GUIDELINES
Although a comprehensive set of criteria and conditions exist that must be met for research groups to obtain federal funding, federal regulation and guidelines overseeing privately funded stem cell research are significantly less stringent. However, standard regulations still apply to all forms of stem cell research conducted within the United States. All of the standard regulations that are applied to research regarding human specimens are also applied to research that uses human subjects or introduces stem cells into human subjects.
The National Academies, which comprises four separate scientific institutions, advises Congress on issues of federal policy as it relates to stem cell research. The National Academies have developed a series of guidelines for all stem cell research to promote ethical research. The academies recommend that each institution that conducts stem cell research create an oversight board to monitor stem cell as well as embryonic stem cell research. The academies also recommend strict guidelines regarding the process of obtaining consent from the donors of oocytes for the creation of embryonic stem cell lines.
In addition, the National Academies have responded to recent concern that both private and publicly funded research endeavors may seek to create chimeras by introducing human embryonic stem cells into the blastocysts of other primates or animals, sparking widespread bioethical concern. At present, the National Academies recommends against performing chimera research. However, strong calls continue for the federal government to directly ban this research outright in the interest of preventing a myriad of ethical concerns.
adult stem cell research
President George W. Bush has also outlined a series of policy statements and an executive order that increase the emphasis that is placed by the federal government on adult stem cell research. Executive Order 13435, signed by President Bush on June 20, 2007, directs the National Institutes of Health to pursue and fund research that uses adult human stem cells. The order also calls for the secretary of the National Institutes of Health to issue a report to the president each year regarding progress that has been made in the adult stem cell research field while specifically outlining the adult stem cell research funded by the National Institutes of Health. This executive order emphasizes the Bush administration’s policy of encouraging additional research into adult stem cells as a potential alternative to embryonic stem cell research.
Many scientific groups object to the added emphasis that is placed on adult stem cell research, feeling that this emphasis detracts from embryonic stem cell research, which may have greater therapeutic potential.
public perception
Gradually, public perception has begun to shift in regard to stem cell research. In the 2004 presidential election, Republican candidate George W. Bush, as well as several Democratic candidates, sparred over the issue of stem cell research, which became a charged and controversial issue during the campaign. Stem cell research has also received additional media coverage and the backing of a number of high-profile celebrities.
Following the 2004 death of Christopher Reeve, a famous actor crippled by a horse riding accident in 1995, stem cell research lobbying efforts gained additional traction. Christopher Reeve had been an outspoken advocate for increased federal funding and support of embryonic stem cell research, which is viewed as a potential source of cures for spinal cord injuries and related neurological diseases. Nancy Reagan, former first lady of the United States, also continues to be an outspoken advocate for federal funding of embryonic stem cell research. Following the death of her husband former President Ronald Reagan in 2004, Nancy Reagan’s support of stem cell research was widely publicized. Nancy Reagan has also been joined by other celebrities including Michael J. Fox, a famous actor who suffers from Parkinson’s disease.
Increased lobbying in support of federal funding of embryonic stem cell research and media attention may lead to shifts in public perception as well, which could affect federal policies in the long term.
new policy considerations
With the perception of increased public support for embryonic stem cell research, several legislative proposals have been crafted that would revise federal policy. The 109th and 110th Congresses have taken up the issue of embryonic stem cell research and stem cell research funding extensively. In the early days of the 110th Congress, the Stem Cell Research Enhancement Act of 2007 (H.R. 3) was successfully passed by both the House of Representatives and the Senate. The legislation called for the lifting of President Bush’s restriction of federal funding for research only on stem cells lines isolated before August 9, 2001. This legislation allowed federal funding for research conducted with other embryonic stem cell lines. However, the legislation also contained explicit provisions allowing use of only those embryos that were left over from in vitro fertility treatments and donated freely without financial incentive. Although the Stem Cell Research Enhancement Act of 2007 successfully passed both houses of Congress, President Bush vetoed the bill on June 20, 2007, shortly after issuing another executive order encouraging federal funding of stem cell research that did not involve the destruction of human embryos.
As international regulation and standards are being further developed in this area, United States policy makers are taking them into consideration. There is a strong concern among many that the United States risks falling behind in stem cell research as the result of an overly stringent policy. Conversely, there are fears that if the United States pursues a national stem cell research policy that is too lax, it will lose moral leadership by being viewed as pursuing a policy devaluing human life.
The issue of federal stem cell research policies, and in particular federal embryonic stem cell research funding, is widely anticipated to be an important issue in the presidential election of 2008. The next elected U.S. president and Congress will have significant implications for the future direction of U.S. federal regulation and funding of stem cell research.
