Globally, reproductive science has been marred by controversy especially with regard to governance. The evolution of this area of biotechnology has attracted both policymakers and legislators from around the world leading. This has elevated discourse on such concerns as the ethics and regulation of this field ( King & Perrin, 2014 ). Across different jurisdictions, the need for regulatory oversight is widely accepted ( Campbell , 2005). However, the structures put in place vary from one country to another. Recently, debates around the area of reproductive health have focused on two aspects of reproductive science. These are cloning technology and embryonic stem cell research ( Gottweis , 2012; Levine, 2011; Hughes et al., 2008). Primarily, the debate on the question of whether the two should be banned, or allowed to flourish but limited by regulatory and legislative oversight. This debate is informed by the fact that both stem cell research and cloning are characterized by moral ambiguity ( King & Perrin, 2014 ). On the one hand, the two are highly beneficial to science and medicine. On the other hand, devoid of proper regulation, they may threaten human dignity and society’s health and wellbeing ( Levine , 2006; Gottweis, 2002 ). Due to this, the debate in most countries features strongly held positions by both proponents and opponents. Three core aspects of the debate have emerged. These are economics, scientific freedom, and cultural norms. It is these three areas that form the basis of legislation and regulations in most countries. In this paper, the history and evolution of stem cell policy in the U.S, as well as its current status, will be examined.
History and Evolution of Stem Cell Regulations in the U.S
The debate on stem cell research in the U.S dates as far back as 1973. Stem cell research is part of the larger embryo research and is closely associated with the debate on abortion. In 1973, the Supreme Court legalized abortion and prohibited using federal funds in research on fetuses, embryos, and fetal or embryonic tissue ( Wertz, 2002 ). At the same time, the Supreme Court allowed unregulated research on the same to continue in the private sector. It is due to this ruling that the private sector commands the biggest proportion of infertility research and treatment, the most outstanding aspect being In Vitro Fertilization (IVF). In 1974, Congress temporarily suspended all federal driven research on embryos, IVF, prenatal diagnosis, embryonic tissues, and infertility while awaiting the establishment of national guidelines. It also established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NC). The commission is responsible for providing the ethical guidelines in the embryo and fetal research. In this regard, it reckons that the societal protection of human subjects also covers fetuses and embryos. Based on this, it recommended the establishment of the Ethics Advisory Board (EAB) which is responsible for reviewing protocols ( Wertz, 2002 ).
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Informed by NC’s recommendations, in July 1975, the Department of Health and Human Services (DHHS) adopted a set of regulations that covered research on embryos. However, the protocols had to be approved by the EAB. At the same time, DHHS lifted the suspension of federal-funded embryo research but did not fund any research in the area. In May 1979, the EAB approved the use of federal funds in a research protocol on IVF and embryo transfers taking place within 14 days but directed that the donors had to be married. The DHHS rejected these recommendations. The EAB charter, as well as funding, expired in 1980. This left a vacuum in which no lawful body was available for the approval of embryo research protocols. Another development took place in 1987. A request was sent to the National Institutes of Health (NIH) for funding of research on the Parkinson's disease by transferring fetal neural cells to the patients' brains. This request was withheld by DHHS in March 1988 while the Ministry of Health argued that the research would motivate those who were ambivalent about abortion to carry out one. Subsequently, the NIH established the Human Fetal Tissue Transplantation Research Panel. In December the same year, the panel voted in support of embryo and fetal research funding. The main argument was that it was possible to separate issues of the morality of abortion from the treatment of diseases using fetal tissue ( Wertz, 2002 ). However, in 1989, DHHS extended the suspension of funding of embryo and fetal research indefinitely, arguing that the research would lead to increased number of abortions.
The U.S attempted to override the moratorium in 1990. However, President George Bush vetoed. In a bid to lift the ban, proponents of stem cell research sued Sullivan, the DHHS secretary in October 1992. In support of this move, on getting to the office, President Clinton instructed the DHHS secretary to lift the ban. The ban was lifted in early 1993 and in response, the NIH published guidelines in preparation for the acceptance of funding. In November 1994, NIH’s Human Embryo Research Panel offered support arguing that creating embryos for the sole purpose of research does not encourage abortions. However, due to public outrage, President Clinton overruled the panel’s decision. Congress, in 1995 banned funding for stem cell research but failed to specify whether the ban covered cells derived from embryos ( Wertz, 2002 ). T he Dickey-Wicker Amendment of 1996 prohibited using federal funds in the creation, for research purposes, of human embryos, or research that involved embryos are discarded, destroyed or subjected to death or injury than the level allowed for in research on fetuses. In 2000 and in an attempt to interpret the Dickey-Wicker amendments, the NIH directed that human embryonic stem cells have to be derived from frozen embryos using private funds and from fertility clinics. The cells must also be created solely for fertility treatment. They have to be more than the clinical need of the donors’, and finally, they ought to be used after obtaining the donor’s consent. The same year, NIH invited proposals for funding. Only two proposals were received in 2001 owing to political instability. Also, their review was halted in a bid to wait for President George W Bush’s decision.
President George W Bush permitted NIH to fund stem cell research in August 2001. However, he directed that the cells must be derived from embryos that have been left on completion of IVF procedures. In announcing via the TV, Bush elevated the place of bioethics in the country. This position further split the proponents and opponents of the stem cell research debate. In November the same year, a private company announced that it had been successful in cloning embryos using adult cells. This was done in a bid to ensure that the cells were compatible with the donor. In November 2001, Bush also urged Congress to declare both therapeutic and reproductive cloning illegal ( Gottweis, 2002 ; Wertz, 2002 ). The Congress passed the Stem Cell Research Enhancement Act in 2005. The Act sought to expand the federal funding of stem cell research to incorporate cells obtained from embryos developed for but not used in IVF. However, President Bush vetoed the bill. In response, the Senate passed their adaptation of the Act. The house also passed it. President Bush, once again, vetoed the bill ( Stevens, 2002 ).
Current Status of the Stem Cell Policy in the U.S
The most recent developments in the Stem Cell Policy took place during President Obama's tenure. This followed the issuing of an executive order in March 2009, which sought to strengthen human embryonic stem cell (hESC) research ( Wolinsky, 2009 ). Subsequently, in July 2009, a new stem cell research policy was adopted (Levine, 2011). This went against the 1995 law that President Clinton signed to ban federal funding in support of research that would lead to destroying of human embryos. The law also prevented NIH-backed research from the creation of new hES cell lines. Additionally, in 2001, President Bush had limited the number of hES cell lines that were available for use in advancing federally supported research to only 21. Thus, Obama's move overturned these previous constraint allowing federal funds to be used in researching hES cell lines that meet NIH's ethical policies ( Hughes et al., 2008).
The legal battle that succeeded promulgation of the new policy added more uncertainty to the stem cell research. The underlying argument was that Obama’s policy violated the Dickey-Wicker Amendment. Consequently, NIH suspended the funding as well as the review of all new hESC research proposals. It also suspended the evaluation of new hESC lines. An appeal by the Obama Administration led to the enjoinment of the preliminary injunction by the District of Columbia’s Court of Appeals in September 2010. This allowed NIH to continued funding of hESC research even as the case went on. Eventually, the District of Columbia’s District Court ruled in favor of hESC research on July 27, 2011. Further, in August 2012, a U.S Court of Appeals for the D.C Circuit upheld a previous ruling in which a lawsuit against the Obama Administration challenged the expansion of hESC research funding by the federal government. In this ruling, the argument was that it was a win for innovative research that was both ethical and scientific. Owing to numerous developments in hESC research and their impact on medicine, President Obama signed the 21st Century Cures Act, also referred to as the Cures Act was signed into law on 13 December 2016 by President Obama. Cures Act will help advance stem cell research. For instance, the Act provides for multi-year funding of the Regenerative Medicine Innovation Project. This project is, in collaboration with Food and Drug Administration (FDA) aimed at supporting clinical research using adult stem cells. This will help further advancing the field of regenerative medicine ( Hudson & Collins , 2017).
The controversy surrounding stem cell research lies in the conflicting positions held by different stakeholders. On the one hand, the opposers argue that harvesting stem cells from embryos is equivalent to killing babies. On the other hand, the supporters hold the position that the benefits accrued by those who benefit from the stem cell far outweigh the short lives of the embryos. Therefore, all regulations have been aimed at creating a balance in order to appease the two sides. For instance, in his August 2001 speech, and while referring to the use of fetal tissue in the treatment of Parkinson's disease, President Bush emphasized that well-formulated research efforts do not necessarily result into success. Nevertheless, he ruled that his government would fund hESC research on the condition that only stem cells had been obtained before August 9th. Likewise, the cells had to be from embryos that were remnants of fertility treatments. This statement, though portraying elements of empathy, was largely political. Such scenarios point to the political angle of the stem cell regulations in the U.S. It also justifies the differences in opinion between all the presidents that have contributed to the debate. Irrespective of this difference, each decision was critical to moving the debate forward. Thus, the signing of the 21st Century Cures Act into law by President Obama can be viewed as being not only important but also vital in enhancing stem cell research in the U.S. This is particularly due to the $6.3 billion funding of the NIH.
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