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7 New Technologies The Ethical and Social Issues Research relating to new technologies in the field of reproductive health is important for many reasons, particularly because such research concerns the creation of the next generation and because the methods being applied represent a marked break with tradition. Artificial in- semination, in vitro fertilization, and the manipulation of embryos have greatly changed what was once the private province of two people joined in a socially approved union. Professor Patricia A. King, of Georgetown University Law Center, has said that the new reproductive technologies are controversial: because they challenge deeply held moral, ethical, and religious values, particularly those values that concern the family and relationships among its members. They involve the deliberate separation of reproduction from the act of human sexuality and from the human body. Important ethical questions also attend many of the social aspects of reproductive health, such as the issues of hospitals turning away women in labor because they do not have insurance or of routine four-week waits before women can begin prenatal care. When in vitro fertilization was being discussed in the the early 1970s, some theologians and other critics in the United States and other coun- tries attacked the procedure as representing unethical experimentation on human beings. The chief moral argument against the fertilization of a 147

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148 SCIENCE AND BABIES human egg in a laboratory dish was that the parents' desire for a child did not entitle them to have it by a possibly unsafe method that might result in a deformed infant. In the United States that argument delayed the further development of IVF. In England, where the perspective on moral issues was some- what different, Drs. Patrick Steptoe and Robert Edwards continued their research and in 1978 achieved a successful live birth by IVF. In the years since, thousands of infants have been born worldwide as the result of IVF. As experience with the technique accumulates, the risk to the embryo is clearly no greater than it is in nature, nor are the parents at any increased risk of harm. The ethical concerns about the safety of the technique have largely subsided. Dr. Kenneth Ryan says: Although similar questions of safety will be raised for any new reproductive technology that is developed, such as cryopreservation of embryos and ova, the moral roadblock to talking risk for the unborn has for the time being been breached. Today ethical questions regarding reproductive technology are not focused so much on the safety of the technology itself but on how it is applied and on where it might be leading. The future of IVF will depend on whether research is allowed and what types of studies are permitted. In the l980s the major question for this technology was whether it was morally right to create life in a dish. In the 1990s, as scientists become increasingly able to analyze (and perhaps alter) the DNA of an embryo, ethical questions will focus on what, if any, limits should be set for embryo manipulation. Basic research on IVF and embryo development would add consid- erably to the information base affecting all of reproductive health. Such work would increase physician understanding of the fundamentals of re- production, of normal pregnancy and normal fetal growth, of the causes of premature labor, and of the reproductive system's marked suscepti- bility to cancer. It would assist research for safer, more effective birth control. The disbanding of the Ethics Advisory Board (EAB) not only blocked research on IVF and embryo development, but it also slowed progress on the study of reproduction. The ability of scientists to sustain human embryos in the laboratory for a week or longer has opened up enormous possibilities in terms of what could be done with sperm, eggs, and the early human embryo. This technology raises questions about our obligations as a society to these gametes and early embryos and about the ethical basis for these

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ETHICAL AND SOCIAL ISSUES 149 obligations. These questions will need to be resolved in order for research on reproductive health to be federally funded and to move forward. As Professor David T. Ozar, of Loyola University, and other observers have noted, "A nation cannot resolve by law and public policy a set of issues on which there is not, within the community at large, a consensus on the underlying values." EARLY DEVELOPMENT OF THE EMBRYO Although research on human embryos has been severely limited by a lack of federal support, studies of animals have contributed to scientists' understanding of many aspects of reproduction. Privately funded investigations have focused on what happens at specific points in the development of a human egg into an embryo. An understanding of this process is imperative to the formation of sound ethical arguments about infertility treatments and basic research on the human embryo. The egg and sperm are haploid cells, cells that contain only half their full complement of chromosomes. After the egg is fertilized by a sperm, a complex series of chromosomal changes occur that ultimately result in a blending of the DNA from the sperm with the DNA of the egg to form a single cell, or zygote, that contains the full complement of chromosomes. From this single cell, all the tissues and organs of the human being, as well as surrounding tissues, such as the placenta, will develop. Cell division occurs several times, forming a tiny cluster of 12 to 16 cells, or the morula. The morula develops a fluid-filled inner cavity as it moves slowly through the fallopian tube. By the time the cluster reaches the uterus, three to four days after fertilization, the cells that will become the embryo can be distinguished from the cells that will form the placenta and fetal membranes. At this stage the cell cluster is termed a blastocyst. The blastocyst develops a covering of cells that enable it to bind to the surface of the uterus. The uterine lining is receptive to the blastocyst for only a short time after ovulation. If the blastocyst implants successfully, on about the 11th day after fertilization the cells begin to differentiate into layers that are precursors of different tissues, although at this time the inner cell mass can still divide and develop into two separate individuals. After the lath day, the basic patterns of the organ systems, including the nervous system, begin to develop. The process continues, and after the ninth week, development advances to the point that the embryo is

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150 SCIENCE AND BABIES defined as a fetus. The fetal stage lasts until birth. During this period the organ systems develop further and the fetus matures and grows in size. As noted in Chapter 6, during fertilization and the first stages of cell division, the chance of a chromosomal mishap is substantial. Pioneering studies by Arthur Hertig and John Rock at Harvard showed that one- third to two-thirds of eggs and approximately 25 percent of embryos have abnormal chromosomes. For this reason and others not yet fully understood, the vast majority of human embryos do not develop as far as the blastocyst stage. Furthermore, if the uterus and blastocyst have not been adequately primed by the production of certain key hormones, implantation may not occur. A substantial proportion of early embryos do not implant and simply disappear, probably flushed from the uterus during menstruation. For the early human embryo, developmental failure appears to be the norm. THE NEED FOR MORE RESEARCH Although very sophisticated techniques are in use at IVF clinics, the success rates for IVF remain low. Because reproductive research is funded chiefly by major IVF centers, pharmaceutical companies, and universities, it has been sparse, uneven, ant! without established priori- ties. As a result, there are considerable gaps in our knowledge of the reproductive process and embryo development. Moreover, as mentioned in earlier chapters, the absence of federal support means no federal over- sight of this research because the National Institutes of Health does not provide scientific peer review for private research. A better understanding of the basics of reproduction and embryo de- velopment not only has the potential for improving infertility treatments, but it also is expected to contribute to many aspects of reproductive health. A recent Institute of Medicine study noted the existence of substantial deficiencies in the scientific underpinnings of reproductive biology. The study also pinpointed many areas in which further research could contribute to the improvement of infertility treatments. The study noted that these deficiencies occur in the basic sciences that underlie the techniques used in various infertility treatments and in embryo transfer. Scientific knowledge that leads to improved infertility therapies may also be applied to the development of better contracep- tive technologies. The study identified over 40 areas that need further research.

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ETHICAL AND SOCIAL ISSUES Some of the research questions that remain unanswered are: beginning? 151 How do we identify a viable embryo? How does cryopreservation affect sperm, eggs, and embryos? What is the optimum number of embryos to transfer during IVF? Why does development stop in some embryos after a normal What are the physiological effects of hormone treatments? What factors control egg maturation and what factors control implantation? What are the elements that lead to the natural wastage of eggs and embryos and how do they operate? One area just beginning to be studied is the diagnosis of genetic and chromosomal disorders in the early embryo before it is transferred to the uterus, as described in Chapter 6. John Fletcher estimates that genetic disorders account for one-third of all admissions to pediatric units and for almost 25 percent of neonatal mortality. The optimal goal of diagnosing inherited diseases in the early embryo, he believes, would be the ability to analyze sperm and eggs, so fertilization could be achieved with gametes that do not carry harmful genes. Aside from studies on infertility, the 10-year de facto moratorium on reproductive health research has dampened studies that could improve the health of mothers and infants. Some examples: Little is known about normal pregnancy and normal fetal de- velopment and what can occur during this process to cause nongenetic diseases or birth defects. Factors that lead to premature labor have yet to be identified. More information is needed about the unusual vulnerability of the reproductive system to malignancies. Additional knowledge might make it possible to ease the heavy drain of pregnancy on the body. More insight into the endocrine control of ovulation that occurs during breastfeeding might aid in the spacing of births. Most male infertility is of unknown origin; research is needed to uncover the causes. ETHICAL AND SOCIAL CONCERNS Certain ethical or social issues aroused by some approaches to infer- tility treatment and by embryo research focus on research in these areas;

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152 SCIENCE AND BABIES other issues are concerned with aspects of the clinical practice. The latter include concerns about the safety of donated sperm, the confidentiality of sperm donors, and the right of a child born as the result of donor sperm to know his or her complete parentage or the genetic/medical aspects of that parentage. Questions have also been raised about the moral and legal status of early embryos and the fate of those that are not used in IVF treatment, including frozen embryos. Equally basic are questions regarding the right of an individual to reproduce; the sale of embryos, eggs, and sperm; and the pros and cons of defining infertility as a disease, which would affect insurance coverage. Ethical concerns that have a direct bearing on research can have im- portant consequences on the funding for that research. The moral status given the embryo in each stage of its development will dictate what re- search or manipulation is considered acceptable at that stage. Such issues as the disposal of unneeded embryos, the creation of embryos expressly for research, and the point at which embryo development research should be permitted are strongly affected by how society perceives the embryo. Not surprisingly, analyses of the ethical stances taken by various segments of society reveal a range of positions concerning embryo re- search. At one end of the spectrum is the Roman Catholic Church and other religious groups that believe life begins when the two haploid cells, the egg and the sperm, unite to form a chromosomally complete cell. The Vatican's Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation, issued in 1987, declares that no moral distinction can be made among any stages of the embryo. According to this position, the absolute sanctity accorded to human life begins with the fertilized egg, making it impossible to discard early embryos or to use them for research. At the other end of the spectrum are those who contend that an embryo is simply a group of living cells and that any value attached to this biological material is in the eye of the beholder. Those who hold this view often point out that a large proportion of naturally conceived embryos do not develop after implantation and that discarding human embryos can be viewed as a similar process. Between these two views lie the positions taken by a number of nations that have systematically examined the issues relating to the new reproductive technologies.

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ETHICAL AND SOCIAL ISSUES 153 Both sides of the abortion issue demonstrate outside the Supreme Court in April 1989. Credit: Uniphoto/Paul Conklin RESOLVING ETHICAL AND SOCIAL CONCERNS Since the mid-1970s countries in which the new reproductive tech- nologies are in use have relied on public discussion to resolve the ethical and social issues that arise. A national public committee is appointed to analyze the issues and to formulate a public policy. The commit- tee, in turn, often receives testimony from technical experts, laypersons, and other committees representing various interest groups. It is a public process of give and take with the goal of achieving a consensus. The officially appointed group then seeks to reach ethical judgments that are both rationally defensible and politically acceptable to large segments of its society. To do so, it often seeks the middle ground on an issue. LeRoy Walters, Director of Bioethics at the Kennedy Institute of Ethics at Georgetown University, has analyzed the statements formulated by these committees. For example, four Australian committees found re- search on Reimplantation embryos ethically unacceptable. Commissions in other countries approved of some kinds of early embryo research, with 6 of 11 accepting research only on embryos left over from treatment programs. Five committee statements, including one from the 1979 U.S.

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154 SCIENCE AND BABIES EAB, allowed the creation of embryos through IVF for research pur- poses. The majority of the committees agreed that no research should be permitted on embryos after 14 days following laboratory fertilization. Many of the recommendations made by these committees have been written into laws controlling certain aspects of infertility therapies or the research associated with them, or both. Dr. Walters observes: Committee statements represent a substantial contribution to the bio- ethics literature on the new reproductive technologies. One can, in fact, trace a kind of evolution in international ethical reflection on these technolo- g~es. Although Dr. Walters- says that committees, commissions, and boards are not likely to replace the work of legislatures, government agencies, and the courts, he feels that periodic committee statements and reports may become the preferred mode of public oversight and social control for at least certain areas of biology and medicine. A similar approach was attempted in the United States in the late 1970s when the EAB was formed. Research involving IVF presented ethical problems for the federal government because religious and right- to-life groups opposed a technique that sometimes results in the destruc- tion of fertilized eggs. The EAB was established in 1978 to review all proposals for federal funds for research on reproduction for the U.S. Department of Health and Human Services (DHNS). In 1979 the EAB made a favorable recommendation for federal support of embryo research to evaluate IVF safety and efficacy. In 1980 the EAB was disbanded. Since then there has been no official body to carry out the department's regulations regarding research on IVF and other aspects of reproduction or to review proposals for scientific studies in this field. The lack of an official avenue for requesting federal funds for such research has had two effects: The development of new knowledge about reproduction, normal pregnancy and fetal development, and the human embryo has either slowed markedly or is not being performed. Whatever research exists is financed privately. Although in July 1988 the DHHS announced plans to recharter the EAB, this has not happened. Meanwhile, the two professional societies in the United States that represent the physicians most involved with IVF have given careful con- sideration to the ethical issues arising from IVF and associated embryo research. The ethics committee of the American College of Obstetri- cians and Gynecologists (ACOG) in 1986 outlined a set of standards to guide research on early embryos. The ACOG recommended using

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ETHICAL AND SOCIAL ISSUES 155 human embryos only when nonhuman embryos could not provide the needed information and studying embryos only up to the 14th day of development. The American Fertility Society (AFS) also examined the ethics of infertility treatment and research. The AFS listed eight technologies that it felt were ethically acceptable, including IVF and embryo transfer, the use of donor eggs, and the use of frozen donor sperm. Six procedures, including the use of frozen eggs and studies of early embryos before the 14th day of development, were viewed as suitable for clinical ex- perimentation. A year later, after reviewing the Vatican's newly issued Instruction on Respect for Human Life, the AFS responded in summary that progressive degrees of respect for the human embryo should accom- pany its progressive development and that experimentation on embryos can be justified and is necessary if the human condition is to be improved. In 1985 a congressional Biomedical Ethics Board was created. To be comprised of six senators and six representatives, the board was as- signed to look into the protection of human subjects in federally funded biomedical research. The selection of members and a 14-member advi- sory committee of scientists, physicians, clergy, and others became an extremely laborious process. Disagreements, chiefly about the prospec- tive appointees' views on abortion and other ethical questions, such as the definition of human life, considerably slowed the formation of the advisory committee. In late 1989 the board ceased to function because of a political impasse over abortion. CONCLUSION Research on new reproductive technologies challenges many of the deeply held moral, ethical, and religious values of society, particularly because such technologies include the separation of reproduction from the act of human union and from the body. Although ethical concerns about the safety of these methods have ebbed, society is now concerned about how the technologies are applied and where they might be leading. The ability to sustain human embryos in the laboratory and, in coming years, the increasing ability to analyze and manipulate them raise questions about what obligations society has to such embryos. Enough is known about early embryo development to realize that it is a multistage process and that a large proportion of embryos are flawed and fail to implant in the uterus. An understanding of embryo development is important in order to form sound ethical judgments about

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156 SCIENCE AND BABIES infertility therapies and embryo research. Although the techniques used for IVF are sophisticated, the success rates for the procedure remain low, and there is still a lot to be learned about the reproductive process and about embryos. Since the EAB was discontinued in 1980, studies have been few and privately funded. The congressional Biomedical Ethics Board, formed in l98S to examine on a broad scale the issues associated with the use of human subjects in reproductive research, is nonfunctional. As noted earlier, without a federal policy and without federal funding, there is no organized direction or peer review. Also, studies aimed at improving maternal and fetal health and women's reproductive health in general are impeded by the absence of an ethics review body. More important, without an active ethics review board there is no public mechanism for addressing the ethical and social concerns that research on reproductive health can arouse. These concerns are many, and the ethical positions on each can be wide ranging. In other nations, appointed committees have successfully achieved a public concensus. Their recommendations have been written into laws to control ethically sensitive aspects of infertility treatments and embryo research. Scientists, ethicists, and other observers have strongly urged that the United States follow a similar course. They suggest reviving the EAB in order to resolve ethical and social concerns about reproductive technology in this country. An active EAB would make it possible to plan the basic research necessary to improve such technology. ACKNOWLEDGMENT Chapter 7 is based in part on presentations made by Kenneth Ryan, John Fletcher, and Patricia King. REFERENCES American College of Obstetricians and Gynecologists. 1984. Human In Vitro Fertil- ization and Embryo Placement. Committee on Gynecologic Practice. Committee Statement. Washington, D.C. American College of Obstetricians and Gynecologists. 1986. Ethical Issues in Human In Vitro Fertilization and Embryo Placement. Committee on Ethics, ACOG Committee Opinion Number 47. Washington, D.C. Andrews, L.B. 1987. Ethical and legal aspects of in vitro fertilization and artifical insemination by donor. Urologic Clinics of North America. 14~31:633-642. Elias, S., and G.J. Annas. 1986. Social policy considerations in noncoital reproduction. Journal of the American Medical Association. 255~11:62-68.

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ETHICAL AND SOCIAL ISSUES 157 Fertility and Sterility. 1988b. Ethical considerations of the new reproductive technolo- gies. By the Ethics Committee (1986-7) of the American Fertility Society, in light of Instruction on the Respect for Human Life in Its Origin and on the Dignity of Procreation, issued by the Congregation for the Doctrine of the Faith. Vol. 49, Supplement 1. Fletcher, J.C. 1989. February 5, D-3. How abortion politics stifle science. The Washington Post. Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, D.C.: National Academy Press. King, P.A. 1986. Reproductive technologies. In the looseleaf series, BioLaw. Frederick, MD: University Publications of America. Norman, C. 1988. IVF research moratorium to end? Science. 241:405-406. Ozar, D.T. 1985. The case against thawing unused frozen embryos. Hastings Center Report, August, 7-12. Ryan, K.J. 1989. The ethics of current reproductive technologies. In Problems in Reproductive Endocrinology and Infertility. Edited by Michael R. Soules. New York: Elsevier Science Publishing Company, Inc. Walters, L. 1985. Ethical issues in human in vitro fertilization and embryo transfer. In Genetics and the Law III. Edited by A. Milunsky and G.J. Annas. New York: Plenum Press. Walters, L. 1987. Ethics and new reproductive technologies: an international review of committee statements. Hastings Center Report, Special Supplement, June. Wood, E.C. 1988. The future of in vitro fertilization. In In Vitro Fertilization and Other Assisted Reproduction. Edited by H.W. Jones and C. Schrader. Annals of the New York Academy of Sciences. 541:715-721.