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Ethics And Human Embryonic Stem Cell Research
Human embryonic stem cell (hESC) research has been surrounded by considerable controversy in recent years, particularly with regard to the ethical issues associated with such research. The scientific facts are relatively straightforward. Stem cells are undifferentiated, unspecialized cells with the ability both to multiply for long periods and to differentiate into specific kinds of cells after being stimulated by chemical or other signals. This latter property means that stem cells could be transformed into specialized cells with specific functions, such as heart muscle cells, blood cells, or nerve cells. Hence promoters of stem cell research claim that it holds promise for the development of therapeutic interventions for a wide range of diseases in which cells have been damaged or destroyed (e.g., heart disease, diabetes, spinal cord injury, and Parkinson’s disease). Patients with leukemia have been routinely treated with blood adult stem cells (ASCs) from compatible donors since the 1970s, and the success of this therapy is often cited as a precedent for future uses of hESCs. However, other types of stem cell therapies are highly experimental and are currently only used in animal models.
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hESCs can be very difficult to isolate and establish in culture, but a number of stem cell lines have been successfully obtained from the inner cell mass of 4to 6-dayold embryos (blastocysts). Cells are isolated at this early stage because it is thought that in later stages of development, they become more restricted in terms of what types of tissues the stem cells can become. A stem cell line contains cells that continue dividing without differentiating into specialized cells and which remain pluripotent (able to differentiate into any cell type with a few exceptions). Stem cell banks hold cell lines that have been produced under standardized conditions, which have been quality controlled, and provide them to basic and clinical researchers (Faden et al., 2003). The UK Stem Cell Bank is the most prominent of these and is overseeing the International Stem Cell Initiative to track and characterize all stem cell lines worldwide.
Blastocysts used for creating hESCs typically are derived from frozen embryos that were originally created as part of in vitro fertilization (IVF) treatments with the intention of achieving successful pregnancies but that were never implanted. In many countries, there are hundreds of thousands of unused frozen embryos stored in assisted reproductive technology (ART) clinics. In some countries (e.g., Australia, Canada, and the United Kingdom), once couples have finished IVF, they can consent to donation of their surplus stored embryos for research purposes, with some limitations (Isasi and Knoppers, 2006). Elsewhere, excess ART embryos cannot be donated for any type of research (e.g., Italy) or creation of hESCs is explicitly banned (e.g., Germany, which does allow importation of lines created elsewhere for research purposes).
Ethical Debates About The Moral Status Of The Embryo
For many, the main ethical issues associated with hESC research are related to the fact that an embryo must be destroyed to obtain stem cells. Some research is underway regarding accessing stem cells without destroying the embryo, but it has so far been unsuccessful. A central ethical question related to this is: What is the moral status of a human embryo? Beliefs regarding when personhood begins (that is, when a human being has moral status) differ. For instance, some religious traditions hold that personhood begins at conception, and thus hold hESC research (and all other forms of destructive embryo research) to be unethical (Doerflinger, 1999; Meilaender, 2001). We should not use embryos as a means to other ends, they claim, and hence should value them as human beings with moral status and full human rights, perhaps deserving of additional protections because they are especially vulnerable and dependent.
A similar argument can be made without relying on religion: Each of us began life as an embryo. If my life is worthy of respect and hence inviolable by virtue of my humanity, so was my life in earlier stages. Since we cannot define a precise time between conception and birth at which we become a person, we must hold embryos to possess the same inviolability as fully developed human beings (for the problems with this argument, see Sandel, 2004). Opponents of embryo research also argue that allowing such research might create a sort of slippery slope, which will lead to increased social toleration of loss of life for vulnerable persons (such as infants and the disabled), although there is limited empirical evidence about social attitudes to support such a claim.
Other more intermediate views hold that the stage at which embryos would be used for hESC research (less than 6 days old) is so early that the embryo cannot be argued to have moral status and hence ethically can be used for destructive research. The time at which personhood or moral status is said to occur differs, but even many religious traditions would nominate implantation or the formation of the primitive streak at around 14 days. These are said to be markers of an individualized human entity with the inherent potential to become a human person; up until this point, the moral status of the embryo is not that of a person, and its use for certain kinds of research aimed at alleviating illness and suffering can be ethically justifiable (and may in fact be preferable to simple destruction, as research is an acknowledgment of the value of the embryo; see Annas et al., 1999). Nonetheless, the embryo should be given some protections, in recognition of its potential as a human being.
More liberal views claim that to attribute basic and equal human worth to an individual requires more than cells that have the potential to develop into a person (Robertson, 1999). They would cite a much later stage of development as the cut-off point, such as the time at which a termination would no longer be legally allowed under normal circumstances, which is much later than when destruction for hESC research would occur. On this view, there is no moral harm committed when an embryo is destroyed or not transferred into the uterus to attempt pregnancy. Some have argued that embryos have higher and lower moral status, depending on whether they are part of a parental project where there is a desire and intention to bring a pregnancy to term. These arguments typically do not imply that we can do anything we wish with embryos (such as cosmetic testing) as we need to give them special respect because of their source and their symbolic value, but it would allow research aimed at curing serious diseases.
The most liberal view holds that embryos are merely body parts until they can exist independently. Thus they have no independent moral status and belong (as property does) to those persons who donated the parts needed to make them. Therefore, all decision making about disposition of embryos should reside with the couple who contributed the genetic materials, and we must respect these rights as we would any other property rights.
There also is a related debate over intentionality, and in particular whether it is ethically permissible to create embryos explicitly for research purposes (see Davis, 1995; Juengst, 2000; FitzPatrick, 2003), either by using IVF to join a sperm and an egg or via cloning (see the section titled ‘Cloning’ below). Some people who would find it ethically permissible to use already created, stored embryos for research oppose the creation of embryos explicitly for research purposes. Societies that permit or support IVF technologies might be argued to have implicitly endorsed the idea that there will be some wastage of embryos inherent in such procedures, but creating new embryos for research is more morally problematic for many. The Council of Europe’s Oviedo Convention of 1997 prohibits the creation of human embryos for research purposes, but it has yet to be ratified by a majority of its member states. Others argue that the creation of embryos for research purposes is ethically permissible, as such embryos do not have the social significance associated with those created for reproduction and hence have a different moral status.
The term cloning is used to describe a range of processes that involve genetic copying, ranging from copies of sections of DNA (genes) to whole organisms (such as plants). Ethical debates about cloning escalated in 1997 with the birth of Dolly the sheep, a whole organism produced using cloning techniques. Cloning is relevant to debates about hESC research because it has the potential to provide a source of tailored stem cells that might be particularly useful for individualized medical treatments. Human embryo clones could be created using somatic cell nuclear transfer (SCNT), which involves taking an egg cell from a woman in a similar way to how eggs are obtained for in vitro fertilization. The nucleus of the egg is extracted, leaving behind only the cytoplasm. A nucleus is then extracted from a somatic (body) cell of a person (who can be another person or the same woman who donated the original egg) and inserted into the cytoplasm.
Under the correct conditions, the entity created should start to divide as would an embryonic nucleus created naturally (i.e., by the union of egg and sperm). The resulting embryo that is formed has the same genetic material as that of the donor of the somatic cell nucleus, instead of its genome being a blend of the two parents as is usual, and its inner cell mass can be used to obtain stem cells as outlined above. The potential advantage of cloning via SCNT is that if the donor of the somatic cell nucleus is also the potential recipient, the resulting hESCs are less likely to be rejected by the recipient’s immune system when transplanted.
Clones could also be created by splitting an embryo at early stages of cell division; by inserting an embryonic stem cell nucleus into the cytoplasm of an egg; or by stimulation of egg cells such that they become embryos without being fertilized by sperm (parthenogenesis), although many of these techniques are highly experimental and have only been used with animal models.
Ethical Debates On Cloning
In 2005 in a split vote, the United Nations adopted a nonbinding resolution to prohibit all forms of human cloning as they are ‘‘incompatible with human dignity and the protection of human life’’ (United Nations, 2005). However, numerous countries (35 voted against and 37 abstained) did not support the resolution because it failed to distinguish between reproductive and nonreproductive cloning. Typically, ethical responses to cloning split in terms of purposes for which cloning will occur, though many claim that this distinction is difficult to maintain and will be difficult to monitor in practice (Bowring, 2004). Most commentators are opposed to human reproductive cloning, where the intention is to produce a cloned human embryo to implant in a woman in order to produce a pregnancy and eventually a child. There do not seem to be particularly strong rationales for creating this type of human clone, and there are concerns about safety and long-term effects based on animal models; reproductive cloning is explicitly legally prohibited in several countries.
Nonreproductive cloning or SCNT is less controversial for those who are not opposed to hESC research, as the clone is created for research purposes and destroyed at an early stage. This type of cloning is permitted in some countries (e.g., Korea and New Zealand) or is allowed with a license (e.g., the United Kingdom, China, and Australia). Some commentators argue that pursuing cloning research is an ethical imperative, so long as there is appropriate oversight, transparency, and accountability (Devolder and Savulescu, 2006). However, SCNT still requires the donation of eggs, and some ethicists have argued that women who are potential donors might be subject to coercion, including economic or workplace pressures (e.g., for those working in stem cell research labs), or that it would be difficult to foster truly informed consent (see Magnus and Cho, 2005). Many countries do not permit payment beyond reasonable medical expenses for egg donors, hence partially mitigating concerns about economic coercion.
Other Issues Related To hESC Research
Another key issue often raised in relation to hESC research is whether ASC (or somatic stem cell) research, which for many is much less morally problematic, might not be as useful (or more so). ASCs are undifferentiated cells found among differentiated cells in a tissue or organ, although their precise origin is unknown, they can renew themselves and it is thought that they can differentiate to yield the major specialized cell types of the tissue or organ, though perhaps not as many cell types as hESCs. Skeptics claim that ASCs are relatively rare, hard to find with available techniques, and difficult to culture outside of the body. Opponents of hESC research argue that ASC research holds as much if not more promise, and hence should be pursued instead of hESC (though they often conflate their ethical claims with scientific ones). Others would claim that there is no need to put the two types of research in opposition to each other, but that both lines should be pursued so long as there is reasonable evidence and expectation of benefit.
Some critics have argued that ART clinics may put pressure on women and couples to produce more embryos than are needed for IVF treatment in order to allow them to donate for research purposes. Consequently many countries have laws that prohibit donating embryos created after a certain date, which usually reflects when legislation governing hESC research was enacted. However, there seems to be little evidence of such practices occurring, and many safeguards (e.g., cooling-off periods following consent to donation and limits on the number of embryos produced) exist to counter these concerns.
A final set of ethical concerns are associated with the commercialization of these technologies and who will have access to any beneficial therapeutics that might be developed. Some feminist critiques of ART note that these technologies can contribute to oppression; in the case of hESC research, altruistic donation of eggs or embryos could be undermined if these donations are used for commercialized research.
Although many have noted that there is considerable hype associated with the promises held out for stem cell research, there still has not been adequate debate about the broader issues associated with it (Dresser, 2005), including the implications for public health. For instance, as disability advocates among others have noted, it is unclear whether the relatively high costs associated with current research, let alone potential costs associated with any therapies which might be developed, reflect adequate assessment or debate regarding appropriate allocation of health-care resources. As with many areas of medicine, it can be argued that a focus on the prevention of relevant disease conditions might prove more beneficial to a larger number of people. In addition, given that initial costs are likely to be extremely high for stem cell-based treatment options, concerns exist about the possibility for inequities in access. Furthermore, there is no consensus on whether limitations should be placed on commercialized research or how any benefits from such research are likely to reach those who most need care. The patenting of stem cell products might well keep them inaccessible for all but the most advantaged. Stem cell banks which keep resources including stem cell lines in the public domain and accessible to researchers worldwide are one key step in making certain that at least some of the results of research stay in the public domain. hESC research is likely to remain fraught with controversy, and policies about governing it should be made through transparent, democratic processes. The disagreements between opponents and supporters of hESC research are unlikely to be resolved, and hence policy makers face a difficult task of finding ways to accommodate deeply held, conflicting views, particularly when formulating public health policies.
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