Ethics of Reproduction

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Chapter 10 Ethics of Reproduction

GENERAL ETHICAL CONSTRUCTS

Any policy or guideline needs to have a certain degree of flexibility built in, because natural rights and human dignity, in the context of creating families, cannot always be clearly defined. We do not have unequivocal answers regarding when life begins, which leaves room for debate in the discussion of the ethics of researching on embryos to obtain stem cells. Furthermore, if we recognize the natural rights of individuals to reproduce, why should this right not be conceded to same-sex couples?

It is understandably difficult to balance an individual’s right to reproductive autonomy and privacy with the societal obligations to protect the potentiality of life. A recent ruling by a judge in Chicago that a couple can sue a fertility clinic for wrongful death of an embryo not cryopreserved further exacerbates this moral confusion.1

The most common ethical norms used to conduct ethical analyses are based on principle-based ethics, communitarian-based ethics, and case-based ethics.

Principle-based Ethics

The moral reasoning of principle-based ethics is based on four principles: autonomy, beneficence, nonmaleficence, and justice.

MOTHERHOOD IN ADVANCED AGE

Programs offering fertility services are increasingly faced with requests from women of advanced reproductive age who seek assistance to become pregnant. Oocyte donation has afforded older women the opportunity to give birth well beyond menopause, and many are taking advantage of this opportunity. Without clear guidelines programs have concerns about the ethical propriety of this extension of the normal reproductive age. As a result they struggle with the following questions: Given that menopause no longer constitutes a biological limit to reproduction, when is a woman too old to give birth? How should the risks of pregnancy in older women be weighed against the rights of women to control their own reproductive lives? How should a woman’s age and life expectancy factor into a clinic policy concerning these services? What do we know about the capacity for postmenopausal women to parent infants and toddlers? What do we know about the development of children resulting from such services and how they fare as the children of comparatively aged parents?

There is no question that the phenomenon of older women seeking to become pregnant through egg donation has increased greatly in the past decade. In the United States between 1991 and 2001, the birth rate for women between ages 40 and 44 increased by 70%, and in 2003 there were 263 births reported in women between ages 50 and 54.2 Although a small number of these births occurred spontaneously, most are attributable to egg donation.3

Why do women of advanced reproductive age want to have children? Their motivations vary widely. A part of the explanation involves the fact that women are marrying later in life, often working in pursuit of their careers and consequently postponing motherhood. Of these women, some have been involved in prolonged infertility treatment with no success and have been referred to egg donation. Others are divorced and remarried and want to have children with their new husbands. In some cases the death of a child prompts a woman to attempt to have another.4 One study found an increased incidence of cosmetic surrogacy among older candidates for oocyte donation and suggested that the desire for pregnancy in this population is motivated by the “desire for youth” and the younger appearance that pregnancy provides.5

How Old Is Too Old?

The question, according to Sauer, has not been answered because the long-term consequences of pregnancy in older women are unknown. He describes the irony that older women, whose ages ordinarily would mean that they would have the poorest prognoses for pregnancy, with donor eggs now have the highest success rates in ART.6 The question of how old is too old presents an ethical dilemma for ART programs because the medical risks are disputable and guidelines for appropriate age restrictions are inadequate. Thus, programs offering oocyte donation are left to their own devices for determining age limits.

Pregnancy complications in older women (women over age 40) are well known. They include pregnancy-induced hypertension, premature rupture of the membranes, vaginal bleeding, and gestational diabetes.3 Those arguing against ART for older women say that this treatment exposes older women to physical risks wholly different from those that younger women are exposed to—risks to the cardiovascular system, for example. Older women have a greater chance of postpartum hemorrhage and are at greater risk for perinatal mortality, cesarean section, and multiple gestations.

Those in favor of this treatment argue that studies on older mothers are misleading because they include spontaneous pregnancies, women who have not been prescreened before pregnancy, women who are socioeconomically disadvantaged, and women who were in poor health before pregnancy.6,7 They contend that women over age 40 entering oocyte donation programs are typically rigorously screened before acceptance into the program. One study reported on women in their sixth decade of life who had safely delivered babies and presented no problems.6

Discipline-wide guidelines are inconsistent or entirely lacking, so programs have no generally accepted standards to provide guidance in making decisions about these patients. For example, the American Society for Reproductive Medicine (ASRM), in its Practice Guidelines, recommends that all recipients of oocyte donation over age 45 undergo thorough medical evaluation, including cardiovascular testing and a high-risk obstetrical consultation before treatment. The guidelines do not include recommendations for age restrictions, however.8 A statement from the ASRM Ethics Committee asserted that oocyte donation to postmenopausal women “should be discouraged” and that patients and programs should determine on a case-by-case basis whether a woman’s health, medical and genetic risks, and provision for child rearing justify proceeding with treatment.9

What About the Children?

Concerns about the children of older mothers seem to fall into two categories: one is about the life expectancy of the mothers and the fear that children will be orphaned at an early age; the other is about the health of the older mothers and the fear that they will not have the energy and the stamina to care for young children. The Human Fertilization and Embryology Authority (HFEA) law enacted in 1990 in the United Kingdom determined that recipients of donor oocytes should not be over age 45, based on the view that it is in the best interest of the child to be parented into young adulthood. Another clinician in the United States used the same argument—that children need an adult to raise them until they can live independently—but recommended that the treatment should be limited to women under the age of 60.10 Those arguing in favor of oocyte donation for postmenopausal women say that society is accepting of older men marrying younger women and having children, so to deny treatment to older women would be agist and sexist. In making this argument they ignore the fact that many older men are biologically capable of fathering children if they choose to do so, so that treatment issues enter into the equation only if donor sperm are required. They also argue that grandparents often take on the parenting role and “bring economic stability, parental responsibility, and maturity to the family unit,” so there is no reason to assume that older women would lack the stamina to raise children.9

It is unclear whether legislators or physicians are better able to judge an older woman’s suitability to be a mother than the woman herself. If an age guideline is to be evidence based, rather than a personal judgment, we presently do not have adequate data to determine an appropriate age limitation. Perhaps the most useful guideline would be to conduct a careful psychological evaluation of older women requesting this treatment, assessing their physical and emotional health status, and inquiring whether they have considered issues and potential problems of raising children in late middle age.

TREATING SAME-SEX COUPLES

An increasingly common ethical concern in fertility treatment centers offering ART is whether or not to accept couples of the same sex as patients. Often the question applies only to gay male couples because many clinics may already routinely treat lesbian women. Yet in recent years gay men as well as lesbian women have become more open about their homosexuality, their relationships, and their determination to become parents.11,12 There has been dramatic recent growth in societal awareness about homosexuality and acceptance of same-sex civil unions. In addition, a growing body of research supports the notion that being reared in homosexual homes does not harm children and that such children are not more likely to become homosexuals themselves.12 These factors have led more ART programs to consider treating same-sex couples of both genders.

A recent survey of ART programs in the United States makes clear that there is no consistent policy regarding the issue of treating same-sex couples, although programs are more likely to reject gay males than they are lesbians.13 Neither is there consistency in ethical concerns about this treatment. Concerns range from questions about the health and well-being of children conceived in all homosexual relationships to specific concerns about the children of gay men. Some common questions about gay fathers include: Can men (and in particular, gay men) be sufficiently nurturing? Are gay men more likely to be pedophiles that abuse their children? Are the sons of gay men more likely to become gay? Others may question whether it is ethically acceptable for programs to accept lesbians for ART while refusing to treat gay males.

Why do lesbian and gay couples want to become parents? It seems that they are motivated by the same factors that motivate heterosexuals to become parents. In fact, a recent study looked at desire and motivation for parenthood in 100 two-mother lesbian families compared to 100 heterosexual families. The author found that the desire to have children was stronger in lesbian women and that they gave more thought to the idea of having children.14 Gay males give the same reasons for parenthood that heterosexual males do; that is, the desire to nurture children, to have the constancy of children in their lives, and to achieve the sense of family that children provide.15,16

The health and well-being of the children of lesbian women conceived through ART has been described in several studies. Researchers found no differences between children raised by lesbian mothers and those raised by heterosexual mothers in terms of gender identity, behavioral development, and psychological development.11,1721 A recent study, the first based on a national sample, compared 44 adolescents in lesbian families and 44 adolescents living in heterosexual families and found no significant differences between subjects on psychosocial adjustment, school outcomes, and romantic relationships.22 Adult offspring of lesbians were studied as well. Young adults between ages 17 and 35 who had been conceived in a heterosexual relationship but raised in a lesbian household were found to have healthy peer relations, to be psychologically stable, and to be no more likely to report same-sex attraction than offspring of heterosexual mothers.23 Though an estimated 6 to 14 million children in the United States live with at least one gay or lesbian parent, children of gay men have not been as thoroughly studied as those of lesbian women.12 For example, in a recent review of 23 empirical studies of children of gay and lesbian parents published between 1978 and 2000 only three studied gay fathers.24 Parental motivation was considered in a study comparing attitudes toward parenting of heterosexual and gay fathers. Gay fathers were more likely to express “the higher status accorded to parents as compared to nonparents” as a motivation for parenting. The authors also asked subjects to describe their interaction with their children. They found no reported differences in terms of intimacy or involvement with the children, although gay fathers reported greater warmth and responsiveness and more limit setting.15,16

Three studies examined the sexual preferences of adolescent and adult offspring of gay fathers and found that most reported a heterosexual orientation.2527 Studies of gender identity, gender role behavior, and sexual orientation found no differences between children of gay men and children of heterosexual fathers. Children of gay fathers are not more likely to become homosexual nor are they more likely to be sexually molested by their fathers.28,29 Gay men who choose to become fathers within a gay relationship most commonly do so via adoption. However, the number of gay men who want to become fathers through ART is growing. Some become fathers through a coparenting arrangement with a lesbian whom they have artificially inseminated; others seek infertility treatment with a surrogate and egg donor.12 It appears that same-sex couples, including gay male couples, are increasingly determined to become parents and many are seeking infertility programs to assist them. Programs need to develop appropriate policies if they are to serve these couples with a focus on the specific needs and concerns they bring to the treatment. There is also a need for continuing studies of treatment outcome for gay couples to help improve the quality of care.

DISCLOSURE VERSUS NONDISCLOSURE WHEN USING DONOR GAMETES

Failure to disclose the origin of the gametes among couples who have conceived a child through the use of donor gametes (whether eggs or sperm) is relatively common.30 Recently, however, many—particularly in European countries—are advocating that couples resorting to donor gametes for reproduction should be obliged to disclose the use of donor gametes to their children once they reach the age of understanding, following policies analogous to those governing disclosure to children that are adopted.31

However, mandating disclosure by a couple is problematic on a number of fronts, and the claim that the practice of gamete donation is similar to adoption is incorrect for many reasons. With gamete donation, one of the parents is the biological parent and the other is the social parent; with adoption, both parents are social parents. With gamete donation the child’s mother, whether biological or not, carries the pregnancy with all of the accompanying psychological interplay. In the case of a donor egg, to ask such a mother (and she is a mother under any definition of motherhood) to tell the child that technically she is not the mother because she is not totally genetically related would strain reasonable medical practice and certainly challenge the bond between mother and child.32

Certainly a preeminent concern is the welfare of the child. However, the benefits accruing to a child from disclosure are difficult to assess and still remain open to many interpretations. In debates about child welfare with adoptions, researchers and policy makers have not yet provided a consensus on what is the best interest of the child.33,34

Donor Privacy

In addition to considerations of child welfare, one must address the impact on the other participants in the process, including the donor, the couple, and the healthcare providers. A donor has to be willing to donate his sperm or her eggs knowing that later he or she can be identified; the couple has to agree in revealing the origin of the gametes to their offspring; the providers have to restrict reproductive services only to couples who agree in writing to disclosure. Without uniform requirements for the collection and maintenance of records, the usefulness of revealing the information is questionable. Accessing any such records from private clinics and banks is likely to be difficult, and certainly the quality of the information contained in them is uneven. In addition, where the child is not in physical harm, courts and legislatures are generally reluctant to intervene in family relationships, including questioning parental judgment about the best interests of the child.32

To force fertility specialists to participate in implementing forced disclosure is problematic as well. Including acquiescence to disclosure as part of screening criteria unjustly interjects social factors (vis-à-vis health factors) into criteria for program acceptance and encourages desperate couples to lie if they disagree. Because relationships vary greatly with background, ethnic origin, and attitudes of both the male and female partner, it would not be unreasonable for a healthcare provider to raise the issue of informing offspring of his/her genetic background at the time the use of donor gametes is considered by a couple. To do more than raise the issue and present known data on the potential psychological ramifications of disclosure and nondisclosure would violate the privacy of the couple’s relationship and interfere with their authority to decide. Programs that use donor gametes should, however, prepare policies on how to handle requests of information from children of donor gametes in future. They may choose to disclose only nonidentifying information when the requesting party has reached age 18, or they may disclose more based on the particular willingness of donors to remove more of their information from anonymity.35

PRE-IMPLANTATION GENETIC DIAGNOSIS

Today there are a number of genetic tests available to detect single-gene and chromosomal disorders. Furthermore, new research tools are being implemented to aid in the discovery of how multiple genes interact in the etiology of multifactorial diseases. PGD allows screening of embryos produced in vitro for the disease of interest and the transfer of unaffected embryos. Some see this practice as reopening the issue of “eugenics” and opening the possibility of attempts to improve or manipulate the human gene pool, contending that this practice may convey negative messages about the social acceptability of genetic disorders and/or disability.36 Others argue that, on the contrary, PGD is providing information and allowing couples to make choices about the tests they have done (i.e., it is not an imposition from the state to the people) and reflecting the rights of individuals to choose what is best for them and their families.

For women with a history of recurrent pregnancy loss, for carriers of known single-gene disorders (e.g., cystic fibrosis, Tay-Sachs disease) or balanced chromosomal translocations, and for women with recurrent failure to achieve a pregnancy after IVF, PGD is justifiable because it should decrease the overall reproductive risks. In fact, it should reduce the risk of pregnancy loss (by allowing transfer only of unaffected embryos) and it should reduce the need for terminating a pregnancy (by avoiding the late discovery of an abnormal fetus). Additionally, it should reduce the risk of multiple pregnancies and associated comorbidity (by transferring the single best embryo) and improve the overall efficiency of IVF (by avoiding embryo transfers when none of the embryos are normal).

The ethical ramifications of PGD are essentially related to the issue of requesting PGD for nonmedical indications, such as family balancing (also known as gender selection or preconception sex selection) and HLA-matching (also known as designer babies). Simply stated, is it permissible to sex embryos? And if not, what are the moral justifications to deny it? Is it morally justified to create embryos and then transfer only the ones HLA-matched with an existing sibling, so to design a perfect tissue donor?

The medical reasons clearly offset the moral arguments of gender selection for the prevention of gender-specific genetic disorders (e.g., hemophilia [X-linked recessive]), muscular dystrophy or incontinentia pigmenti [X-linked dominant]). But in the absence of clear medical indications—as in the case of PGD for family balancing—the moral arguments to deny PGD service become stronger.

The main concerns are based on the assumption that by offering sex selection on demand, the natural sex ratio would be altered, because in aggregate couples might request preferentially the gender of one sex over the other. It is therefore important to establish guidelines when the request of gender selection is made:

Issues that need to be addressed for both human leukocyte antigen (HLA) matching and for gender selection requests are the fates of the non-HLA-matched embryos and of the embryos of the undesired gender.

Using procreation and ART as a means to save another sibling life could be seen as exploitation. Creating a child (savior) whose own value and identity could later be affected by the act of being organ donor for their sibling requires a full psychological evaluation of the requesting families, and the risks of instrumentation and exploitation, albeit potential, need to be fully addressed.

Currently, only a minority of couples seem to give importance to the sex of their children, and even fewer seem to be willing to use the service of preconception sex selection for nonmedical reasons.37

FERTILITY PRESERVATION: ETHICAL CONSIDERATIONS FOR ADULTS AND CHILDREN

Adults

The contemporary use of powerful chemotherapeutic and radiotherapy protocols are procuring cure or significantly extending survival for many patients with cancer. As a result of this progress quality of life issues after cancer are emerging. Included in this quality of life paradigm is a consideration to protect fertility from the toxicity of these treatments. Many strategies have been devised to pursue fertility preservation, some well-established, such as embryo freezing (which is not always an option; e.g., unmarried women or young prepubertal girls); others, such as egg freezing and ovarian tissue freezing, still experimental. Likewise for men, the option of semen cryopreservation before chemotherapy or radiotherapy is well established, but scarcely used; spermatogonial harvesting and testicular tissue freezing for later autotransplant or xenografting are also still experimental.

From an ethical standpoint, the key reason for pursuing fertility protection is to restore personal autonomy to those who are unable to conceive.38 However, because many of the technologies are innovative but experimental, it is difficult to design clinical trials: how to provide proper informed consent and respect for autonomy? Who to include or exclude in the trials? How to assess the risks? Can the moral principle of beneficence be upheld if ovarian tissue or testicular tissue cryopreservation poses future risks to any children who might result from this technique? Ideally the decision about who is a candidate for fertility preservation should be rendered by a team including a medical oncologist, reproductive endocrinologist, pathologist, and psychologist, all guided by written protocols that can be shared with patients.38 Patients should not be provided with false hopes, and alternative plans such as no intervention should also be part of the discussion. It is reasonable in the absence of grant funds to seek reimbursement from patients to cover the expenses of the research, but there should be no charge for clinical fees. Finally, for the time being, fertility preservation involving ovarian and testicular harvesting for freezing should be performed only in a few specialized centers working with proper International Review Board-approved consents.

Children

Impaired future fertility is a remote consequence of exposure to cancer therapies that is difficult for children to conceptualize but potentially traumatic to them as adults. Unfortunately, the modalities that are available to children to preserve their fertility are limited by their sexual immaturity and are essentially experimental. For boys who cannot produce mature sperm, harvesting and cryopreservation of testicular stem cells with the hope of future autologous transplantation or in vitro maturation represents a promising method of fertility preservation. For girls, isolation and cryopreservation of ovarian cortical strips/primordial follicles followed by in vitro maturation of gametes when fertility is desired is a possible option. Extensive research is still required to refine these modalities in order to safely offer them to patients.38

Assisted reproductive technologies must be scrutinized on the basis of efficacy and subjected to rigorous ethical deliberation before they can be offered to patients. The modalities involved in fertility preservation of young children are no exception to this rule. In addition to ensuring that the basis for offering the intervention is morally just, the execution of the intervention must be deemed ethically sound. This determination requires that the intervention in question be evaluated within an ethical framework that considers it in terms of beneficence, respect for persons (autonomy), and justice.39 It can be argued that fertility preservation aimed at children is ethical because it prevents morbidity (reproductive and psychosocial) and safeguards their reproductive autonomy.40 Therefore, the main ethical question concerns the process involved in achieving fertility preservation and the techniques required. The answer is found in an exploration of the potential risks of the intervention to the patient and his/her progeny, the special situation of children as research subjects and patients, and the potential abuse of the technologies in the future.40,41

Children represent a unique and vulnerable population with respect to medical research. They have diminished autonomy, diminished capacity to understand the risks and benefits of research objectives, and lack the ability to provide consent for research studies. As a result, they require special protection against potential violation of their rights that may occur during research investigations.39,42 Until very recently, institutional attitudes impeded significant participation by children in medical research for fear of such exploitation.39 This attitude was attributed to several historical episodes of the unethical targeting of children as medical research subjects.

One of the most notorious episodes was the Willowbrook Hepatitis Study, an examination of the natural course of infectious hepatitis and of the use of gamma globulin for its treatment and prevention. All children studied were patients at the Willowbrook State School—a New York State inpatient psychiatric facility. Enrollment into the study began in 1956. The subjects were deliberately infected with hepatitis by injection of purified viral preparations or by ingestion of stool extracts from infected persons. At one point during the study, admission to the hospital was contingent on permission to enroll a child in the study.42

Ethical guidelines to protect children as research subjects were outlined with the publication of the Belmont report in 1979, generated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Children should not be exploited to participate in pediatric research, nor should they be deprived of the benefits research has to offer because of their vulnerable status. Research involved in childhood fertility preservation should be conducted on patients who could experience personal benefit from the research, eliminating the prospect of exploitation for the gain of others.

The immediate risks associated with gamete isolation to the individual child may be slightly greater than minimal. However, in the context of his or her illness this might be tolerable, especially if the procedure to procure the gonadal tissue is combined with a therapeutic procedure that requires anesthesia.43 Additional risks associated with fertility preservation are more difficult to assess due to the lack of data available to quantify them. For instance, the risk of reintroduction of malignant cells to the patient when gonadal tissue is autografted cannot be estimated becausee only limited animal data exist. Moreover, the risk to offspring conceived through such technologies, such as inheritance of genetic predisposition to cancer or other unforeseen genetic risks are unknown presently.40 Patients and their families must be informed of the potential benefits and the treatment alternatives for the process to be considered ethical. With respect to childhood fertility preservation, proper attainment of informed consent from a legally authorized representative (i.e., parent or guardian) and of childhood assent must be ensured.39,42 Assent—the active affirmation by the research subject—can be obtained from incompetent minors and it should be obtained from children whenever possible.

The benefits of gamete cryopreservation are promising, but they are largely unquantifiable because human data on the survival of gametes after the freeze-thaw-transplant process is limited. Until more data become available, we cannot tell patients what percentage of gametes will survive and what the probability of conception is and must not provide them with false hope. Alternatives to gamete cryopreservation should be discussed, and patients should be given the option of no intervention.40 Barriers to the consent process for fertility preservation interventions may develop. Parents may be competent to consent for their children, but the scenario is very complex both clinically and emotionally. Therapeutic obligations may limit the amount of time allotted to families to consent in a truly informed and voluntary way. It has been suggested that to overcome some of the practical obstacles involved in the consent process, it should be performed in stages.44

If a two-stage process is adopted, the issues of gonadal harvesting/storage and gamete manipulation could be handled as two separate subjects at two distinct time points. The decision to harvest gametes would be made at the time of cancer diagnosis and consent for the procedure would be left to parents/guardians. The decision of how to use the gametes after they have been isolated could be made at a future point by the patient in adulthood. At such a point in time, the patient would be better able to express personal preferences about the handling of the tissue based on an enhanced capacity to understand the nature and ramifications of the interventions proposed.

ETHICS OF EMBRYO RESEARCH FOR STEM CELL EXRACTION

The subject of research on embryos created through IVF presents a variety of ethical and legal issues. The central part of the debate is the moral status of the embryo.45 This debate is not unique to the 21st century scientist or bioethics scholar; in fact it can be traced to Aristotle, who wrote of the “ensoulment” of the human at a particular stage, as did the pre-Socratic philosopher Heraclites before him. Religious views of conception have been extensively debated in Judeo-Christian and Muslim scholarship dating to the earliest religious texts in those traditions. The contemporary question of the moral status of the embryo emerged during the U.S. controversy over the legality of abortion in the 1960s through the 1980s, and continues to be a central issue in the discussion of embryo research as grounding for stem cell research. Views on the moral status of the human embryo normally take one of the following three forms:

The position that an embryo has no moral status can be argued in several different manners. Because the fetus fully depends on the pregnant woman for development, many ethicists believe that it cannot be viewed as a unique entity. The moral concerns expressed by those who hold this position about embryo research are focused on the long-term social implications of embryo research for the status of born persons, particularly those with disabilities. However, it is not held that the destruction of an embryo is inherently morally problematic.

The position that the fetus has intrinsic moral status is grounded in the view that a person is created at a moment in time that can be linked both to the consummation of an act by those who participate in its creation, and to the physical and legal initiation of that person’s participation in the human community. The metaphor most often used to describe the status of the fetus for these purposes is that of baby; the ever-increasing presence of the fetus in public and private life has contributed to the view that from the “moment” of conception a person can be identified, independent of the risks that face a person so defined, and regardless of the plain differences between such a person (e.g., in the case of a frozen embryo) and a person who participates as a baby, child, or adult in the institutional life of the community. Given this view of conception and the embryo, the use of an embryo for research purposes is exactly tantamount to the use of any other vulnerable subject in research without consent, research that poses not only a great risk, but in many cases also has the clearly anticipatable outcome of death for the subject.

The moral issues surrounding embryo research leave the status of the embryo highly contested. The lack of consensus about the status of the embryo and the morality of research has resulted in what might be somewhat contradictory and unclear legal definitions in the United States at the state and federal level. Because it is extremely difficult to define the status of the embryo and the question still remains hotly contested, most of the legislation tries to steer away from making a definitive statement that would outrage either side of the debate.

The legality of embryo research also varies from country to country. Experimentation on the embryo for the purposes of developing stem cell and other technologies, and for general knowledge, is legal in the United Kingdom and three Australian states under certain circumstances. In Germany and Italy, embryo research is banned completely. In the United States, debates over the legality of embryo research tend to pivot on prior state court holdings, federal agency rules and directives, or state laws on the status of the embryo.

One’s position on the ethics of stem cell research depends on the question of when life begins and what bearing each developmental milestone has on the moral standing of a fetus, but also on the underlying view one holds about values and ethics. For the consequentialist theory, the ends determine an action’s moral status, and good ends justify the means necessary to achieve those ends. Embryos can be experimented on or even destroyed, because the ends of embryo research outweigh whatever damage is done to embryos—including the destruction of embryos—as long as it is clear that the embryo’s suffering or death is not more morally undesirable (to itself or to others, understood in a variety of ways) than is the suffering of the patient or community or family affected by a treatable or potentially treatable disease.

Whatever its religious or scientific underpinnings, the ethical debate surrounding human stem cells has recently centered on how the human stem cells are derived and on whether or not they should be protected from destruction, much like an adult is.45 Using leftover IVF embryos for the purposes of human stem cell research raises complex questions about the status of the embryo, the value of human life, and whether limits should be set regarding the interventions into human cells and tissues. Furthermore, questions about adequate informed consent, oversight, and regulation also come prominently into play.

Those who support human stem cell research argue that an embryonic stem cell, even though it is derived from an embryo, is not itself an embryo and thereby would never continue to develop into a fetus, child, and adult. Each stem cell is only a cell that can be triggered to become a specific kind of tissue yet could not be triggered to become an individual. Furthermore, the embryo at the blastocyst stage has not developed any kind of nervous tissue, and thus extracting individual stem cells would not be painful for the embryo. Because the embryos used for stem cell research come mostly from leftover IVF embryos, which would otherwise be discarded, the proponents of stem cell research argue that it is better to use such embryos to find cures for debilitating diseases rather than to discard them, benefiting no one.

One attempt to resolve the debate over stem cell research involved the suggestion that researchers might obtain stem cells from embryos without actually engaging in the destruction of those embryos.46 It also was suggested that totipotent cells might be removed from 4- or 8-cell preimplantation embryos destined for PGD.47

Implications for ART Clinics

The processes whereby embryos are created (whether from donor eggs and/or sperm intended for research purposes or as a byproduct of reproductive healthcare), analyzed, stored, thawed, or destroyed are all processes that require the technologies, clinical expertise, patient population, and institutions of ART. It is thus no surprise that the largest research programs in the field have employed reproductive endocrinologists, biologists, ART psychologists, and social workers. Ethical issues related to participation in stem cell research include three key problems. First is the question of whether and under what circumstances patients or research subjects should be allowed to participate in the donation of reproductive materials for stem cell research, particularly where that research involves the creation of embryos for research purposes. Second is the question of whether reproductive clinicians and technologists should be involved in the nonreproductive use of cloning technologies for the creation of nuclear transfer-derived stem cells. Third is whether and when clinicians involved in the derivation of embryonic stem cells should be held responsible for the failure of those cells in clinical trials or therapies using those cells. At this time, on none of these issues is there professional consensus, although all three issues continue to receive the attention of the ethics boards of professional societies, such as the ASRM in the United States, and of bioethicists.

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