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Ethical Issues in Reproductive Health: That Delicate Balance

WHEC Practice Bulletin and Clinical Management Guidelines for healthcare providers. Educational grant provided by Women's Health and Education Center (WHEC).

Ethics and ethical decision making activities remind us all the ethical obligations we must follow in the day-to-day dealing with our patients, our society, and ourselves. When research is carefully targeted to identify and solve reproductive health problems, it can potentially serve as a powerful tool for health and social development. Research has a central role in generating the evidence that decision-makers need to institute new (or change existing) policies, procedures, practices and interventions. Research can be used also to identify harmful or ineffective practices or policies that need to be discontinued. Furthermore, research findings can be used for advocacy to create awareness about specific reproductive health issues or for promoting the adoption of necessary interventions or models of best practice designed to prevent or mitigate consequences of risks to health. As the 21st century unfolds with all its technologic advances, the concept of medicine as a profession persists. Ethics in obstetrics and gynecology focuses on the relationship of obstetrician, gynecologists and their colleagues within the specialty and beyond. We hope this forum offers ethical guidance on the responsibilities of healthcare providers to their patients and the ethical obligation not to abuse this trust.

The purpose of this document is to address ethical principles, concepts, leading approaches to bioethical thought, and outlines a process for ethical decision making in obstetrics and gynecology. Good individual decision making encompasses four elements: knowledge, knowledge of moral theories and concepts, cultural perception and respect for cultural differences. Knowledge of ethics and sensitivity towards ethical issues varies widely among physicians. It is important for healthcare providers to improve their skills in addressing ethical decisions through organized continuing education, or personal experience and reading. These problems can not be solved with medical knowledge alone. Responsible decisions in these areas depend on a thoughtful consideration of the values, interests, rights, goals, and obligations of those involved, all of which are the concern of reproductive health ethics.

Caring for Patients:

One of the challenges in developing an ethics guide with a universal appeal is that it has to transcend social, cultural and national issues. Ethical decision-making is, however, often culturally bound and occurs within legal framework of a given country. Moral dilemmas may arise because legitimate acts may be unethical and ethical actions may in some cases be illegal (e.g., providing abortion services in countries where abortion is considered illegal). The centrality of the patient in any physician-patient relationship reminds us to put the interests of the patient before any other consideration. "Rights" and "interest" are key ethical concepts in the debate on the regulation of reproductive healthcare services. Every decision takes some thought and organization before decision is made. To create the atmosphere in which effective decisions can be made and implemented; the following is helpful even in a crisis situation.

  • Setting up a workable ethical decision-making framework: Create the atmosphere of caring as you deliberate; and identify those involved with the ethical dilemma. Involve them in the decision-making when it is appropriate.
  • Listen to their stories before you proceed: Patient autonomy and the concept of informed consent or refusal are central issues regarding patient choice to have or not to have a treatment option.
  • Be aware of your personal prejudices and feeling as your respond: Be honest with yourself about how those factors can affect your decision-making ability.
  • The process of decision making: Each physician should exercise judgment when determining whether information presented to the patient is adequate. The practice of evidence-based medicine involves understanding the scientific basis of treatment and the strength of the evidence and applying results of the strongest evidence available to medical decision making.
  • Naming the dilemma: It involves identifying the values in conflict. If they are not ethical values or principles, it is not truly an ethical dilemma. It may be a communication problem or an administrative or legal uncertainty. When principles conflict, a choice must be made about which principle should be honored.
  • Sort the issues: Although these matters often become confused, they need to be identified, particularly when the decision is an ethical one.
  • Explore the patient's concerns: Try to understand what appropriate ethical principles are involved for society, for you and for the involved parties in the ethical dilemma. What are the facts, value and policy concerns; and allow patients and their healthcare providers to reach a mutually acceptable decision. Care rendered to an individual patient does not take place in a vacuum but rather within a community. Decisions made in one sphere affect those in the other.

Research Involving Women:

The role of research in influencing policy decisions varies according to the nature and type of research undertaken. It is often helpful to think of factors influencing research utilization in relation to three phases with in the research style: pre-research, during research, and post-research. Often, critical factors influencing research utilization are beyond the control of researchers (e.g. the prevailing political climate, or economic conditions influencing the national health system). It helps to develop a comprehensive communication for engaging with the stakeholders early in the research process. Research that is viewed as important and relevant by those who have a stake in the research topic (including the ultimate beneficiaries) is likely to receive more serious attention by the stakeholders. Perfect ethical decisions are seldom possible. Human experimentation is a necessary and important part of biomedical research because certain information can be obtained in no other way. However, we can learn from past decisions and try to make better choices in future, particularly when they lead to policy making.

Guidelines for protection or research participants have been established by various governmental agencies and are applicable to women of childbearing potential as well as pregnant women. Involvement in research protocols should not diminish a woman's expectation that she will receive appropriate medical care during the study and in the future. Health care providers have a responsibility to provide the most appropriate clinical management, whether or not a woman is a participant in research. Research objectives should not affect clinical management. The potential benefit from participation of women in research include reduction in morbidity and mortality from sex-specific disease processes, as well as reduction in fetal, infant, and maternal mortality and morbidity.

The recent movement to enroll more women in clinical research can be justified by ethical principles: beneficence, nonmaleficence, autonomy, and justice. Because disease processes may have different characteristics in women and men and because women and men may respond differently to treatments and interventions, women need to be included as subjects in clinical research. For women to benefit from the results of research (beneficence), the research must be designed to provide a valid analysis as to whether women are affected differently from men. Such differential analysis is necessary not only to benefit women, but also to prevent harm; if data from studies with men are inappropriately extrapolated to women, women may actually suffer harm (nonmaleficence). The potential participant should be encouraged to consult her physician independently before deciding to participate in a research study. At the woman's request, the researcher should provide information about the study to her physician. If relevant, this information may be included in the requirements of the study and its possible outcomes and complications. Both the researcher and the primary caregiver should guard against inflating the patient's perception of the therapeutic benefit expected from participating in the study. An attempt should be made to take into account protection of human subjects, the eligibility of women to participate in research, and the benefits that society could derive from participation of women in research.

Gender Testing and Gender Selection:

Gender selection is the practice of using medical techniques to choose sex of the offspring. Patients may request gender selection for different reasons. The at-home fetal gender DNA test is already widely available. It is very likely that other direct-to-consumer DNA tests will become available in the very near future. There are two major issues to be considered: one is the accuracy of the test, and the other is the ethical and societal implications of the test. Potential consumers need to be educated about the importance of peer-reviewed, objective clinical trials that have validated the technology. Currently reliable techniques for selecting sex are limited to post-fertilization methods, which includes techniques used during pregnancy as well as techniques used in assisted reproduction before the transfer of embryos fertilized in vitro. Recent attention, however, has focused on preconception techniques, particularly flow cytometry separation of X-bearing and Y-bearing spermatozoa before intrauterine insemination or in vitro fertilization (IVF). In cultures in which males are highly valued than females, gender-selection technologies if not properly regulated could prove to be a social, economical, and cultural disaster. Recommendations and monitoring of the healthcare providers who may participate in gender-selection should be considered.

Many organizations have issued statements concerning the ethics of provider participation in gender selection. The ethics committee of the American Society for Reproductive Medicine maintains that the use of preconception sex selection by preimplantation genetic diagnosis for non-medical reasons is ethically problematic and "should be discouraged". Both the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and the Programme of Action adopted by the United Nations International Conference on Population and Development opposed the use of sex selection techniques for any non-medical reason. This group urges governments of all nations "to take necessary measures to prevent...prenatal sex selection". The very idea of preferring a child of a particular sex may be interpreted as condoning sexist values and hence create a climate in which sex discrimination can more easily flourish. Non-medical uses of sex selection techniques have the potential to undermine equality between the sexes; moreover, this ethical objection arises irrespective of the timing of selection (ie, preconception or post-conception) or the stage of development of the embryo or fetus.

The principal medical indication for sex selection is known or suspected risk of sex-linked genetic disorders. For example, 50% of males born to women who carry the gene for hemophilia will have this condition. By identifying the sex of the preimplantation embryo or fetus, a woman can learn whether or not the 50% risk of hemophilia applies, and she can receive appropriate prenatal counseling. To ensure that surviving offspring will not have this condition, some women at risk for transmitting hemophilia choose to abort male fetuses or choose not to transfer male embryos. Direct identification has the advantage of avoiding the possibility of aborting an unaffected fetus or deciding not to transfer unaffected embryos. The practice of sex-selection to prevent sex-linked genetic disorders has a place in the development of these technologies; meeting requests for sex selection for personal and family reasons, such as family balancing may ultimately support sexist practices. Because patients are entitled to obtain personal medical information, including information about the sex of their fetus, it can sometimes be impossible for healthcare providers to avoid unwitting participation in sex selection. We hope this chapter helps healthcare providers facing requests from patients for sex selection by calling attention to the relevant ethical considerations.

Surrogate Motherhood:

The obstetricians and gynecologists who facilitate surrogacy arrangements should be aware of any statutes or court cases in the state in which he or she practices. In counseling individuals seeking a child through surrogacy or a woman who is considering becoming a surrogate, the physician should encourage them to consider the possible consequences of a surrogacy arrangement, including potential legal complications. Surrogacy can be classified on the basis of the source of the genetic material. Eggs, sperm, or both may be donated, thereby altering the "intended parents" biologic relationship to the child. The different types of relationships that are possible: genetic (either, both, or neither intended parent), gestational (the surrogate), and social or rearing (the intended parents); give rise to both conceptual problems about the nature of parenthood and legal problems as to who should be considered the parents responsible for the child.

Arguments for surrogate parenthood arrangements: Surrogate parenthood can allow a couple to have a child when they would otherwise be unable to do so except by adoption, because of an inability to achieve pregnancy or medical contraindications to pregnancy for the intended mother. Adoption, however, does not provide a genetic link to the child, an important consideration for some prospective parents. Surrogate parenthood is chosen by some prospective parents because of a desire for genetic linkage or for practical reasons, such as the scarcity of adoptable children. In the United States, the freedom to decide whether and when to conceive or bear child is a highly protected right. The intended parents and surrogate mothers should be free to cooperate in procreating, at least in cases of medical need and where care is taken to avoid harming others, especially the prospective child. Some women become surrogates primarily for altruistic reasons and see their services as a gift.

Arguments against surrogate parenthood arrangements: These are based on the harms that the practice may be thought to produce; harms to the child that is born, harms to the surrogate herself, harms to her existing children if she has children, and harms to society as a whole. It is surely harmful to any child to be the object of a custody dispute. In addition, the rejection of an infant -- for example rejection of a disabled infant by both intended parents and surrogate mother, is a significant harm. Depersonalization of a pregnant woman as a "vehicle" for the genetic perpetuation of other individuals may harm not only surrogate mothers but also the status of women as a whole. There also is a concern that redefining concept of motherhood may threaten traditional understandings of parenting and family.

Children are much more vulnerable than adults. Harms to children who have no choice in a matter are more serious, from an ethical standpoint, than harms to adults who make a choice that they later regret. Further, a distinction should be drawn between harms that inevitably or almost invariably are associated with a practice and harms that perhaps could be avoided through advance planning, appropriate counseling, or oversight mechanisms. To avoid conflict of interest, the physician should not facilitate a woman's becoming a surrogate mother for a couple whom the physician also is treating. The physician should ensure that appropriate procedures are used to screen and counsel both the intended parents and the surrogate. Referral for mental health counseling should be provided before initiation of a pregnancy 1) to permit the potential surrogate to explore the range of outcomes and possible long-term effects and 2) to evaluate her psychological risks and vulnerabilities as well as the possible effects of surrogacy on her existing relationships and on any existing children. The physician should avoid participation in medical care arising from surrogacy arrangements in which the financial or other arrangements are likely to exploit any of the parties. The physician is therefore obligated to become as informed as possible about the financial and other arrangements between the surrogate and intended parents to make ethical decisions about providing medical care. The obstetricians, gynecologists and specialists in reproductive endocrinology have an ethical responsibility to review the risks and benefits of surrogate parenthood fully and fairly with couples who are considering surrogacy arrangements.

Pre-embryo (Stem-cell) Research:

We acknowledge the diversity of ethical opinions among the healthcare providers and in society at large, on stem-cell research. Positions range from complete rejection of all human pre-embryo research to approval of generating pre-embryo solely for research. Even among those who accept pre-embryo research on ethical grounds, there is disagreement about the conditions under which it may be carried out ethically. The pre-embryo refers to an entity in a stage of development that begins after fertilization and ends approximately 14 days later with the appearance of the primitive streak (that is, the band of cells at the caudal end of the embryonic disc from which the embryo develops). As more and more biologic information has become available, it has shaped judgments regarding the degree of moral weight to be given to a pre-embryo. Because this information is relevant to many of the ethical questions surrounding pre-embryo research, it is useful to begin with the knowledge available about the biologic processes involved. Deliberations about ethical problems and guidelines often have included a weighing of the importance of the research in relation to its risks to individuals and society and in relation to varying perceptions of the moral status of the pre-embryo.

In 1974, the U.S. Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Consequently, a national Ethics Advisory Board (EAB) was established to review in vitro fertilization (IVF) research protocols and certain protocols for fetal research. In May 1978, the EAB agreed to review the ethics, legality, safety, efficacy, and scientific merit of IVF research receiving National Institutes of Health support. In a May 4, 1979, report the EAB agreed that "the human embryo is entitled to profound respect; but this respect does not necessarily encompass the full legal and moral rights attributed to person". The EAB recommended allowing the use gametes of informed and consenting donors to study the safety and efficacy of clinical IVF, provided that developing human cells not be sustained longer than 14 days in vitro. In 1998, the EAB ceased to exist because of the Administration's unwillingness to appoint new members and since 1994; no federal support of IVF research had been permitted. In the United States, private and university-based research has proceeded in the context of infertility treatment. The American Fertility Society (AFS) (currently the American Society for Reproductive Medicine) Committee on Ethics recognized the ethical dilemmas implicit in IVF research and recommended specific guidelines for conducting such research.

Potential Benefits: The goals and objectives of pre-embryo research are numerous, varied, and in some cases relatively uncontroversial. These are: increasing knowledge about embryogenesis and embryopathy; developing better understanding of the biology of human implantation; understanding better the causes of spontaneous abortion; developing more effective or simpler forms of contraception; improving methods of IVF treatment for both male and female infertility; developing pre-embryo biopsy techniques for a preimplantation diagnosis of genetic or chromosomal abnormalities by new technologies such as DNA amplification; and improving the technique of microinjection of spermatozoa directly into eggs.

Risks of Harm: In all research, the value of the knowledge to be gained must be balanced with the risk of harm that is incurred. In the case of pre-embryo research, there are 3 areas of potential harm. First, some pre-embryo research, such as in vitro testing and genetic therapy, can be scientifically validated and clinically beneficial only if there is subsequent transfer of the pre-embryo to a woman's uterus in an attempt to achieve pregnancy. Although, such research may enhance the prospects for a normal, successful pregnancy, it also may reduce them. Second, pre-embryo research may be performed in a way that risks infringement of the rights of sperm and oocytes donors. Third, the harm that is of central concern to many, however, is the potential harm to the pre-embryo itself, not only damage but sometimes destruction, and the possible subjection of the pre-embryo to research that is not aimed at its own benefit. Allied to this is a concern that the manipulation of pre-embryo will diminish societal respect for human life in general.

Scientific information alone cannot resolve questions about the moral status of the pre-embryo. Scientists themselves sometimes disagree in interpreting available data, and science is not the sole arbiter in debates about values. Two factors taken into account by national committees and commissions that have identified a 14-day limit for research on human embryos are: 1) the lack of individuation of the developing entity during that period, and 2) the natural failure of a high percentage of zygotes to develop into embryos. Policies should be developed in light of ethical and legal considerations, and they should cover eventualities such as informing gamete providers of what will be done with pre-embryos in the absence of a written statement of the gamete providers' wishes. Couples considering IVF therapy should be fully informed of the options available to them and of the policies of the IVF program. It is helpful for physicians to reflect on and share the basis of their own views and to recognize and explore the ethical perspectives of their patients and colleagues.

Adoption / International Adoption:

Adoption is a commonly used alternative strategy for family building. Although adoption is not a medical event per se, obstetricians and gynecologists may find themselves at the center of adoption issues because of their expertise in the assessment and management of infertility, pregnancy and childbirth. With proper evaluation and treatment, the majority of couples evaluated for infertility will achieve pregnancy. For those who fail simpler specific treatments, assisted reproductive technology and adoption are both realistic options. Couples considering adoption have a wide range of choices including social agency adoptions, private adoptions, and international adoptions. In some states, private adoption is not legal, but where it is, private adoption can be effective, more rapid alternative to adoption through a social agency. In most cases, the biologic mother has the opportunity to know the adopting parents and may reconsider her decision and reclaim her child for a time before the adoption is finalized. Those who prefer anonymity or who wish to avoid such potentially devastating disappointments will likely make a different choice. Couples interested in adoption should be referred to those knowledgeable about adoption laws in individual states and the available options.

Physicians commonly provide information, advice, and counsel, and they refer birth parents and prospective adoptive parents to adoption agencies. They also may be asked to link or match pregnant women with families desiring adoption. The physician's role in education is to ensure that adoption is introduced into the description of alternatives for women with unwanted pregnancies and for potential adoptive parents. Physicians have a responsibility to provide information about adoption to all patients with unwanted pregnancies and to all patients with infertility concerns. Physicians may have both positive and negative personal biases about adoption for various reasons. Physicians have an obligation to present alternatives fairly, regardless of personal values and beliefs. They should not advocate for or against relinquishment or adoption. It is also consistent with the ethical obligation to promote what is good for the patient. A lengthy counseling session, in which the risks and benefits of adoption are weighed against other alternatives, may be indicated for some patients. Physician also should ensure that financial incentives do not bias the presentation of information about adoption. Patients count on the guidance of physicians for medical decisions. Adoption, however, is only tangentially a medical matter, and few physicians are expert in this field. The best counsel will permit the involved parties to explore their options fully and make a decision that arises out of their own belief, values, needs, and circumstances.

Since 1986, American families have adopted more than 230,000 children from other countries. In 2004, more than 22,000 children from around the world arrived in the U.S. Many children have had perinatal complications, including low birth weight, prematurity, no prenatal care, prenatal exposures to drugs and alcohol, and abandonment. After birth, most reside in orphanages, and many experience malnutrition, emotional and physical neglect, lead-exposure and environmental deprivation. Thus, these children represent a high-risk group for later complications. Many healthcare facilities in USA have added many services to meet the changing needs of these children and their families, and have developed an active research program designed to improve the quality of care in various orphanages in various parts of the world. Seminars for Pre-Adoptive Parents offer an opportunity for parents considering or in the process of international adoption, to learn about the medical and developmental issues their child may present. With the enormous changes in technology, many of these reviews are now conducted entirely over the Internet. The quality and quantity of information available vary widely, depending on the country of origin. Although a great deal of information can be gleaned even from the most unpromising medical reports, it is important to educate parents about realistic goals of the consultation. Virtually all children are tested prior to adoption for Hepatitis B, HIV, and syphilis; laboratory tests may differ from those obtained after the child arrives in the U.S. Parent preparation is key to family adjustment and satisfaction after international adoption. Even after suffering adversity in early life, most internationally adopted children do extremely well; it is not possible to evaluate the child's risk of learning disabilities or attention deficit disorder, or to make promises about the child's likelihood of "catch-up" growth or development after adoption.

The adoption field is evolving, and the issues are complex. Obstetricians and gynecologists can play helpful and effective roles in adoption as educators and advisers. Physicians can be excellent sources of information, can assist in weighing risks and benefits, and can provide emotional support. Physicians should involve themselves in counseling and screening roles with great care because potential exists for unintended misuse of the physician-patient relationship. If asked to serve as a broker in an independent adoption, the physician's role is to refer the patient to an appropriate agency or adoption resource. Among all the roles that physicians play in adoption, that of a broker is perhaps the most hazardous because of ethical issues related to undue influence, competing obligations, and lack of expertise. Brokering adoptions is properly the role of and independent authority or agency, which is in a position to protect the interests of all involved parties -- the child, the birth parents, and the adoptive parents. For these reasons, many hospitals have bylaws prohibiting staff physicians from direct involvement as adoption brokers.

Editor's Note:

Providing advice on simpler issues, we do not pretend to answer all questions but we hope this helped to raise important ethical issues and questions, and guide healthcare providers on how to respond to the ethical dilemmas they face in their everyday lives. We hope our attempts are also useful reminder to readers that these dilemmas are shared with many others across the globe, and that often there are no easy answers. Although the deliberate creation of human embryos for scientific research is complicated by ethical and practical issues, a detailed understanding of the cellular and molecular events occurring during human fertilization is essential, particularly for understanding infertility. Research on human embryonic stem cells holds great promise for the development of therapies for chronic and debilitating diseases that are currently untreatable. The use of statutory regulation of medical treatments is always contentious. This is particularly so in the case of assisted reproductive technologies (ART), and the treatment offered through IVF and related procedures. These technologies challenge traditional understandings of the family and motherhood, but also raise questions about the status of the human embryo and how it should be treated. Governments do have a role to play in the regulation of assisted reproductive technologies, but restricted access; embryo research; conflicts with other laws; and confusion because of poor drafting or lack of foresight are not in the best interest of individuals and the communities. Science and law must co-exist. The development of sound policies and procedures, in a timely and coordinated fashion is essential for the greater good. It is important to remember that ethical theories are just that, theories. They do not provide the absolute solutions for every ethical dilemma. They do provide a "framework for ethical-decision-making".

Suggested Reading:

  1. United Nations
    Gender equality, equity and empowerment of women. In: Population and development: programme of action adopted at the International Conference on Population and Development. 1994 Sept 5-13; Cairo, New York (NY): UN; 1995. p. 17-21
  2. World Health Organization (WHO)
    Ethical Issues -- Scientific & Ethical Review Group (SERG)
  3. American College of Obstetricians and Gynecologists (ACOG)
    Ethics in Obstetrics and Gynecology
  4. National Institutes of Health (NIH)
    National Human Genome Research Institute
  5. American Bar Association
    Facts about Women and the Law (requires Adobe Reader)

    Published: 7 December 2009

    Women's Health & Education Center
    Dedicated to Women's and Children's Well-being and Health Care Worldwide