Search

Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated when risks are substantial but not offset by direct benefit to participants, and the benefit to society (“social value”) is context-dependent? We encountered these issues while serving on a multidisciplinary, independent expert panel charged with addressing whether human challenge trials (HCTs) in which healthy volunteers would be deliberately infected with Zika virus could be ethically justified ( 1 ). Based on our experience on that panel, which concluded that there was insufficient value to justify a Zika HCT at the time of our report, we propose a new review mechanism to preemptively address issues of bystander risk and contingent social value.

Medical professionals do not have the right to curtail patients' knowledge or exploit its limits to further their moral worldviews. Because patients lack medical information and don't know what they don't know, conscientious objectors must still inform patients about all options, including the ones they won't participate in.

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population.

Objective Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

HIV/AIDS is among the most serious diseases confronting women who are pregnant. It is also one of the few areas of research involving humans where there is a long track record of research involving pregnant women. Yet the HIV/AIDS research community has struggled to expand the research agenda from research to prevent mother-to-child transmission of HIV to research encompassing issues pertaining to the pregnant woman’s own health. Research questions of interest include: which antiretrovirals are safest and most effective for pregnant women; how best to pursue preventive regimes for pregnant women who are not infected; or, how to treat HIV’s deadly co-infections, such as tuberculosis (TB), during pregnancy. In this chapter, we describe two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose foetal risk without the prospect of foetal benefit. In particular, the HIV/AIDS context shows how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the foetus; and creative trial designs can advance no-benefit studies without imposing foetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations.

For parents, the experience of having an infant in the NICU is often psychologically traumatic. No parent can be fully prepared for the extreme stress and range of emotions of caring for a critically ill newborn. As health care providers familiar with the NICU, we thought that we understood the impact of the NICU on parents. But we were not prepared to see the children in our own families as NICU patients. Here are some of the lessons our NICU experience has taught us. We offer these lessons in the hope of helping health professionals consider a balanced view of the NICU’s impact on families.

To describe obstetrician-gynecologists' (ob-gyns') views and willingness to help women seeking abortion in a variety of clinical scenarios.We conducted a mailed survey of 1,800 U.S. ob-gyns. We presented seven scenarios in which patients sought abortions. For each, respondents indicated if they morally objected to abortion and if they would help patients obtain an abortion. We analyzed predictors of objection and assistance.The response rate was 66%. Objection to abortion ranged from 16% (cardiopulmonary disease) to 82% (sex selection); willingness to assist ranged from 64% (sex selection) to 93% (cardiopulmonary disease). Excluding sex selection, objection was less likely among ob-gyns who were female (odds ratio [OR] 0.5, 95% confidence interval [CI] 0.4-0.8), urban (OR 0.3, 95% CI 0.1-0.7), or Jewish (OR 0.3, 95% CI 0.1-0.7) compared with male, rural, or religiously unaffiliated ob-gyns. Objection was more likely among ob-gyns from the South (OR 1.9, 95% CI 1.2-3.0) or Midwest (OR 1.9, 95% CI 1.2-3.1), and among Catholic, Evangelical Protestant, or Muslim ob-gyns, or those for whom religion was most important, compared with reference. Among ob-gyns who objected to abortion in a given case, approximately two-thirds would help patients obtain an abortion. Excluding sex selection, assistance despite objection was more likely among female (OR 1.8, 95% CI 1.1-2.9) and United States-born ob-gyns (OR 2.2, 95% CI 1.1-4.7) and less likely among southern ob-gyns (OR 0.3, 95% CI 0.2-0.6) or those for whom religion was most important (OR 0.3, 95% CI 0.1-0.7).Most ob-gyns help patients obtain an abortion even when they morally object to abortion in that case. Willingness to assist varies by clinical context and physician characteristics.II.

Childbearing women, healthcare providers, and commentators on birth broadly identify control as an important issue during childbirth; however, control is rarely defined in literature on the topic. Here we seek to deconstruct the term control as used by childbearing women to better understand the issues and concepts underpinning it. Based on qualitative interviews with 101 parous women in the United States, we analyze meanings of control within the context of birth narratives. We find these meanings correspond to five distinct domains: self-determination, respect, personal security, attachment, and knowledge. We also find ambivalence about this term and concept, in that half our sample recognizes "you cannot control birth". Together, these findings call into question the usefulness of the term for measuring quality or improving maternity care and highlight other concepts which may be more fruitfully explored.

Objective To describe fertility patients' preferences for disposition of cryopreserved embryos and determine factors important to these preferences. Design Cross-sectional survey conducted between June 2006 and July 2007. Setting Nine geographically diverse U.S. fertility clinics. Patient(s) 1020 fertility patients with cryopreserved embryos. Intervention(s) Self-administered questionnaire. Main Outcome Measure(s) Likelihood of selecting each of five conventional embryo disposition options: store for reproduction, thaw and discard, donate to another couple, freeze indefinitely, and donate for research; likelihood of selecting each of two alternative options identified in previous research: placement of embryos in the woman's body at an infertile time, or a disposal ceremony; importance of each of 26 considerations to disposition decisions; and views on the embryo's moral status. Result(s) We found that 54% of respondents with cryopreserved embryos were very likely to use them for reproduction, 21% were very likely to donate for research, 7% or fewer were very likely to choose any other option. Respondents who ascribed high importance to concerns about the health or well-being of the embryo, fetus, or future child were more likely to thaw and discard embryos or freeze them indefinitely. Conclusion(s) Fertility patients frequently prefer disposition options that are not available to them or find the available options unacceptable. Restructuring and standardizing the informed consent process and ensuring availability of all disposition options may benefit patients, facilitate disposition decisions, and address problems of long-term storage.

All professionals are concerned about maintaining the appropriate limits in their relationships with those they serve. Pediatricians should be aware that, under normal circumstances, caring for one's own children presents significant ethical issues. Pediatricians also must strive to maintain appropriate professional boundaries in their relationships with the family members of their patients. Pediatricians should avoid behavior that patients and parents might misunderstand as having sexual or inappropriate social meaning. Romantic and sexual involvement between physicians and patients is unacceptable. The acceptance of gifts or nonmonetary compensation for medical services has the potential to affect the professional relationship adversely.

To estimate the incidence of maternal cardiovascular and pulmonary events and the prevalence of other comorbid conditions among pregnant smokers.We queried the Nationwide Inpatient Sample (NIS) from the Healthcare Cost and Utilization Project (HCUP) of the Agency for Healthcare Research and Quality (AHRQ) for pregnancy-related discharge codes for the years 2000-2004. The prevalence of various conditions and the incidence of various complications were compared between smokers and nonsmokers.The majority of smokers were young and white and had public insurance. Smokers were more likely to have experienced deep vein thrombosis (odds ratio [OR] 1.3, 95% confidence interval [CI] 1.1, 1.6), stroke (OR 1.7, 95% CI 1.2, 2.5), pulmonary embolus (OR 2.5, 95% CI 2.1, 3.0), and myocardial infarction (OR 4.6, 95% CI 3.3, 6.4). They were 3 times more likely to have experienced influenza or pneumonia (OR 2.9, 95% CI 2.7, 3.2) and 15 times more likely to have bronchitis (OR 15.2, 95% CI 12.8, 18.2). They were more likely to suffer from a number of comorbidities, including asthma (OR 4.0, 95% CI 3.7, 4.2) and gastrointestinal ulcers (OR 3.7, 95% CI 2.6, 5.5). Although they were less likely to have experienced gestational diabetes (OR 0.9, 95% CI 0.9, 1.0), preeclampsia (OR 0.8, 95% CI 0.8, 0.9), or eclampsia (OR 0.7, 95% CI 0.6, 0.9), they were more than 5 times as likely to have experienced an ectopic pregnancy (OR 5.4, 95% CI 4.6, 6.3).Smoking has a negative impact on maternal health. Counseling about the risks of smoking in pregnancy should include not only fetal risks but maternal risks as well.

Over the last several years, as cesarean deliveries have grown increasingly common, there has been a great deal of public and professional interest in the phenomenon of women ‘choosing’ to deliver by cesarean section in the absence of any specific medical indication. The issue has sparked intense conversation, as it raises questions about the nature of autonomy in birth. Whereas mainstream bioethical discourse is used to associating autonomy with having a large array of choices, this conception of autonomy does not seem adequate to capture concerns and intuitions that have a strong grip outside of this discourse. An empirical and conceptual exploration of how delivery decisions ought to be negotiated must be guided by a rich understanding of women’s agency and its placement within a complicated set of cultural meanings and pressures surrounding birth. It is too early to be ‘for’ or ‘against’ women’s access to cesarean delivery in the absence of traditional medical indications - and indeed, a simple pro- or con- position is never going to do justice to the subtlety of the issue. The right question is not whether women ought to be allowed to choose their delivery approach, but rather, taking the value of women’s autonomy in decision-making around birth as a given, what sorts of guidelines, practices, and social conditions will best promote and protect women’s full inclusion in a safe and positive birth process.

Deciding when and how to incorporate patient preferences regarding mode of delivery is challenging for both obstetric providers and policymakers. An analysis of current guidelines in four clinical scenarios (prior cesarean, twin delivery, breech presentation, and maternal request for cesarean) indicates that some guidelines are highly prescriptive whereas others are more flexible, based on physicians' discretion or (less frequently) patient preferences, without consistency or explicit rationale for when such flexibility is permissible, advisable, or obligatory. Although patient-choice advocates have called for more patient-responsive guidelines, concerns also have been raised, especially in the context of discussions of cesarean delivery on maternal request, about the dangers of unfettered patient-preference-driven clinical decisions. In this article, we outline a framework for the responsible inclusion of patient preferences into decision making regarding approach to delivery. We conclude, using this framework, that more explicit incorporation of patient preferences is called for in the first three scenarios and indicate why expanding access to cesarean delivery on maternal request is more complicated and would require more data and further consideration.

It is estimated that more than 500,000 women annually experience a mental illness during pregnancy. Although approximately a third of these women will be prescribed medication, the majority receives no treatment, partly because ethical challenges to including pregnant women in research protocols have impeded studies necessary to establish maternal and fetal effects of medication, appropriate dosing, and the relative risks of undertreated mental illness. Because mental illness is a frequent complication of pregnancy (particularly anxiety and depression), clinicians will be called upon to ethically navigate uncertain treatment recommendations with sensitivity to patient values. The following discussion reviews the history of current guidelines to research with pregnant women, common clinical presentations of women experiencing mental illness in the perinatal context, and relevant ethical frameworks to inform patient care.

Objective To describe factors that affect infertility patients' decision making regarding their cryopreserved embryos. Design Forty-six semistructured in-depth interviews of individuals and couples participating in IVF programs. Setting Two major southeastern academic medical centers. Patient(s) Fifty-three individuals, including 31 women, 8 men, and 7 couples. Main Outcome Measure(s) Qualitative analysis of interview transcripts. Intervention (s) None. Result(s) Seven broad themes informed participants' decisions about embryo disposition: family and personal issues, trust, definition of the embryo, prospective responsibility to the embryo, responsibility to society, adequacy of information, and lack of acceptable disposition options. Many wished for alternative options, such as a ceremony at the time of disposal or placement of embryos in the woman's body when pregnancy was unlikely. Conclusion(s) Recent debates regarding embryo disposition do not reflect the range of values that infertility patients consider when deciding about frozen embryos. In addition to questions about the embryo's moral status, decision making about embryos is informed by a range of factors in the lives of individuals who created them. These perspectives may have important implications for the content and timing of informed consent, facilitating embryo disposition, and advancing policy debates about the ethics of frozen embryo use.

Objective To summarize the existing literature regarding the social implications of embryo cryopreservation and outline areas in need of further study. Result(s) The potential social impact of oocyte cryopreservation has not been investigated. Embryo cryopreservation has been increasingly used to improve the cost-effectiveness of in vitro fertilization (IVF) and expand the options available to infertile couples, yet its widespread adoption has occurred more rapidly than our ability to study the social consequences for the couples and health professionals involved. For maintaining cryopreserved embryos, the existing literature is fragmented and incompletely explores the effects on an infertile couple's psychosocial health and personal relationships, their family planning strategies, or their preferences for the disposition of the embryos. Managing unclaimed embryos continues to create challenges for assisted reproduction professionals. Conclusion(s) We currently lack a thorough understanding of the numerous social implications of cryopreservation. Major areas for future research include the impact of stored embryos on couples' fertility intentions and psychosocial health, factors that affect couples' decisions about embryo disposition, strategies to minimize unclaimed embryos, and the consequences of oocyte/ovarian cryopreservation.

Despite significant debate about appropriate disposition of cryopreserved embryos, information about the attitudes of individuals who will ultimately decide about disposition, namely individuals who underwent IVF to create them, is limited. Our aim was to qualitatively describe the range of attitudes of individuals regarding their cryopreserved embryos. We conducted in-depth, semi-structured interviews with 31 women and 7 couples from two reproductive endocrinology clinics who have, have had, or anticipate having cryopreserved embryos as a result of IVF. Thirty-one individuals/couples had from 1 to more than 20 embryos in storage. Many expressed uncertainty about plans for embryo disposition, citing a lack of resources for informed decision-making and concerns about available options. When questioned about potentially acceptable options, 28 specified future attempts at pregnancy, 14 specified donation for research purposes, 9 specified donation to another couple, and 4 specified thawing and discarding spare embryos. These data suggest a wide range of attitudes among individuals regarding disposition of their cryopreserved embryos. Further study is needed to quantify the prevalence of these attitudes and concerns.

With recent recognition of the need for data about how to treat illness during pregnancy has come appreciation of the myriad challenges to responsibly conducting research involving pregnant women. ...

BACKGROUND: Important clinical, social, and ethical questions are associated with the evaluation and use of surgical approaches aimed at correcting fetal anatomic abnormalities. In particular, the expansion of maternal-fetal surgery to ameliorate nonlethal fetal conditions has intensified the need to address issues about the adequacy of technology assessment and the safety of those who undergo these novel procedures. APPROACH: After discussions at a multidisciplinary conference, we reviewed the development and current practices of maternal-fetal surgery and analyzed the relevant ethical issues concerning the use of maternal-fetal surgery for nonlethal conditions, focusing on the correction of myelomeningocele. FINDINGS: Characterizing nonvalidated maternal-fetal surgery procedures as “innovative therapy” blurs the boundaries between research and therapy and creates uncertainty about the obligations of clinicians and researchers. Further, maternal-fetal surgery raises ethical issues related to maternal risks and benefits, informed consent, distinguishing lethal from nonlethal conditions, withholding unproven treatments, entrepreneurship, and prioritization. RECOMMENDATIONS: To help ensure that maternal-fetal surgery will be studied and eventually applied in a scientifically and ethically sound manner, we offer several recommendations. First, innovation in maternal-fetal surgery should be conducted and evaluated as research. Second, women must be considered research subjects in these trials. Third, the informed consent process must ensure adequate comprehension and genuine voluntariness in those considering participation. Fourth, discriminatory and fearful attitudes toward individuals with disabilities should be addressed explicitly prior to making a decision to proceed with maternal-fetal surgery in an attempt to correct such disabilities. Fifth, maternal-fetal surgery should not be performed for cosmetic indications unless and until there is reliable evidence that maternal-fetal surgery can be performed safely and that long-term side effects on women and their offspring are minimal. Sixth, centers of excellence should be established for conducting research and providing maternal-fetal surgery. Seventh, funding for research on maternal-fetal surgery should be considered in the context of societal needs.

Objective: To review the advances in the treatment of human immunodeficiency virus (HIV) infection and revisit the medical, ethical, and legal issues surrounding infertility management in HIV-infected couples. Design: Analytic review. Result(s): HIV infection continues to be a serious public health and reproductive issue. However, present policies which allow for the categorical exclusion of HIV-infected individuals from infertility services should be reconsidered in light of improvements in the prognosis of infected individuals and a dramatic decrease in the risk of vertical transmission. An analysis of the ethical cogency of the arguments against the provision of services does not substantiate the exclusion of HIV-infected individuals; rather, the principle of justice requires that HIV-infected women be treated the same way as a woman who might have an increased risk of conceiving a child with a disability or a may have a decreased life expectancy due to a chronic illness such as diabetes. Ethical disagreement notwithstanding, with the precedents recently established by the Americans with Disabilities Act (ADA), discrimination based on HIV status would also likely be unlawful under most circumstances. Conclusion(s): With advances in the treatment of HIV infection, contextualized counseling and a respect for patients' decisions regarding infertility treatment should be adopted as public policy. It is neither ethically nor legally justifiable to categorically exclude individuals from infertility services on the basis of HIV infection.

The use of aggregated quality of life estimatesin the formation of public policy and practiceguidelines raises concerns about the moralrelevance of variability in values inpreferences for health care. This variabilitymay reflect unique and deeply held beliefs thatmay be lost when averaged with the preferencesof other individuals. Feminist moral theorieswhich argue for attention to context andparticularity underline the importance ofascertaining the extent to which differences inpreferences for health states revealinformation which is morally relevant toclinicians and policymakers. To facilitatethese considerations, we present an empiricalstudy of preferences for the timing andoccurrence of health states associated withhormone replacement therapy (HRT). Sixteenwomen between the ages of 45 and 55 wereenrolled in this pilot study. Theirpreferences regarding five health statesassociated with HRT (menopausal symptoms, sideeffects of HRT, breast cancer, myocardialinfarction, and osteoporosis) were assessed inquantitative terms known as utilities. Twostandard methods, the visual analog scale (VAS) and the standard gamble (SG), were used toassess utility and time preference (calculatedas a discount rate). The wide variability ofresponses underlines the importance oftailoring health care to individual women'spreferences. Policy guidelines whichincorporate utility analysis must recognize thenormative limitations of aggregatedpreferences, and the moral relevance ofindividual conceptions of health.

When surgery is performed on pregnant women forthe sake of the fetus (MFS or maternal fetalsurgery), it is often discussed in terms of thefetus alone. This usage exemplifies whatphilosophers call the fallacy of abstraction: considering a concept as if it were separablefrom another concept whose meaning isessentially related to it. In light of theirpotential separability, research on pregnantwomen raises the possibility of conflictsbetween the interests of the woman and those ofthe fetus. Such research should meet therequirement of equipoise, i.e., a state ofgenuine uncertainty about the risks andbenefits of alternative interventions ornoninterventions. While illustrating thefallacy of abstraction in discussions of MFS,we review the rationale for explicitacknowledgment of the essential tie betweenfetus and pregnant woman. Next we examinewhether it is possible to meet the requirementof equipoise in research on MFS, focusing on afetal condition called myelomeningocele. Weshow how issues related to equipoise innonpregnant populations appear also in debatesregarding MFS. We also examine evidence insupport of claims that the requirement ofequipoise has been satisfied with respect to``the fetal patient'' while considering risks andbenefits to gestating women only marginally ornot at all. After delineating challenges andpossibilities for equipoise in MFS research, weconclude with a suggestion for avoiding thefallacy of abstraction and achieving equipoiseso that research on MFS may be ethicallyconducted.

Reasoning about the fetus is a complex, often vexing, challenge. Indeed, at the center of some of the most provocative and difficult bioethical debates in the last decade are questions about the re...

The lack of human data available to inform evidence-based treatment for illness during pregnancy has led to calls for greater inclusion of pregnant women in research, but the extent of their current representation is poorly characterized. Our objective was to measure the current exclusion of pregnant women from industry-sponsored clinical trials as a baseline for future comparison.We compiled data from studies enrolling women of childbearing potential posted on www.ClinicalTrials.gov between 1 October 2011 and 31 January 2012. The review was limited to open United States-based phase IV interventional studies sponsored by the pharmaceutical industry evaluating treatment of conditions that may be experienced by but are not limited to pregnant women and did not involve a medication classified as potentially teratogenic. If there was no mention of pregnancy in the inclusion or exclusion criteria, we contacted a study representative to confirm that pregnant women could be enrolled.Of 558 qualifying industry-sponsored studies, five (1%) were designed specifically for pregnant women. Of 367 phase IV clinical trials with verified inclusion and exclusion criteria, 348 (95%) excluded pregnant women and 19 (5%) did not.We found the exclusion of pregnant women from industry-sponsored clinical trials to be common practice. Moving beyond reflexive exclusion and developing thoughtful criteria for inclusion of pregnant women in clinical research would likely advance the evidence base to inform treatment decisions during pregnancy and lead to better health outcomes for women and children.

If women are excluded from research, their only option may be to take a medication in an uncontrolled clinical environment without the data to inform dosing or safety considerations specific to pregnancy.

"Therapeutic" bed rest continues to be used widely, despite evidence of no benefit and known harms. In this commentary, we summarize the Cochrane reviews of bed rest and propose an ethical argument for discontinuing this practice. Cochrane systematic reviews do not support "therapeutic" bed rest for threatened abortion, hypertension, preeclampsia, preterm birth, multiple gestations, or impaired fetal growth. This assessment has been echoed in other comprehensive reviews. Prescribing bed rest is inconsistent with the ethical principles of autonomy, beneficence, and justice. Hence, if bed rest is to be used, it should be only within a formal clinical trial.

Our language both reflects and influences our attitudes and behavior. This Roundtable Discussion explores the language used in obstetrics and in the interactions between caregivers and women or their families: What do practitioners say to mothers and families during labor? At birth? In consultations? To describe what is happening? To encourage a woman's efforts? To lighten the atmosphere? When advising about possible interventions? Medical terminology in perinatal care can often be deceptive or confusing, not only for mothers but for caregivers. The authors of this Roundtable, representing health professionals from different specialties and interests in the field, have examined some examples of such language use, misuse, and abuse in perinatal care. (BIRTH 39:2 June 2012).

The concept of “normal birth” has been promoted as ideal by several international organizations, although debate about its meaning is ongoing. In this article, I examine the concept of normalcy to explore its ethical implications and raise a trio of concerns. First, in its emphasis on nonuse of technology as a goal, the concept of normalcy may marginalize women for whom medical intervention is necessary or beneficial. Second, in its emphasis on birth as a socially meaningful event, the mantra of normalcy may unintentionally avert attention to meaning in medically complicated births. Third, the emphasis on birth as a normal and healthy event may be a contributor to the long-standing tolerance for the dearth of evidence guiding the treatment of illness during pregnancy and the failure to responsibly and productively engage pregnant women in health research. Given these concerns, it is worth debating not just what “normal birth” means, but whether the term as an ideal earns its keep. (BIRTH 39:4 December 2012)

The past 2 decades have yielded profound advances in the fields of prenatal diagnosis and fetal intervention. Although fetal interventions are driven by a beneficence-based motivation to improve fetal and neonatal outcomes, advancement in fetal therapies raises ethical issues surrounding maternal autonomy and decision-making, concepts of innovation versus research, and organizational aspects within institutions in the development of fetal care centers. To safeguard the interests of both the pregnant woman and the fetus, the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics make recommendations regarding informed consent, the role of research subject advocates and other independent advocates, the availability of support services, the multidisciplinary nature of fetal intervention teams, the oversight of centers, and the need to accumulate maternal and fetal outcome data.

Fertility patients often struggle with decisions about disposition of embryos remaining after fertility treatment. We aimed to identify predictors and correlates of decisional conflict among patients facing these decisions.We analyzed results from a survey of 2210 patients from nine geographically diverse US fertility clinics. The main outcome measure was decisional conflict about embryo disposition, as measured by the decisional conflict scale (DCS).Of 1244 respondents who returned the survey, 1005 with cryopreserved embryos and DCS scores were included in the analysis. Of the respondents, 39% reported high decisional conflict (DCS ≥ 37.5). Thoughts about future childbearing were associated with high decisional conflict: respondents who were either uncertain about whether to have a baby in the future or sure they did not want to have a baby were at higher odds of high decisional conflict than participants who desired a baby [adjusted odds ratio (aOR) = 3.93, P0.001 and aOR = 1.69, P = 0.04, respectively]. Also associated with high decisional conflict were being likely to have embryos thawed and discarded (aOR = 2.08, P0.001), donated for research (aOR = 1.66, P = 0.01) or frozen 'forever' (aOR = 1.90, P = 0.01); being likely to choose compassionate transfer if it were available (aOR = 1.65, P = 0.03); attributing high, but not full, moral status to human embryos; not having enough information; and not being satisfied with the informed consent process.Decisional conflict about frozen embryo disposition differs according to reproductive preferences that may vary according to stage of treatment. Informed consent for embryo disposition should be revisited periodically, with serious discussions about disposition after childbearing is complete.

Membership in academic medicine carries with it special challenges and responsibilities in such matters as patient-physician relations, physician conduct and practice, and conflict of interest. This chapter addresses a limited selection of ethical issues in academic medicine that particularly apply to women’s healthcare.

In 1987, a young woman named Angela Carder, pregnant and dying from cancer, was ordered by a court of law to undergo a cesarean delivery against her and her family's wishes. She and her baby both died. Three years later, an appeals court took an extraordinary stand: it vacated the order that ended their lives and upheld pregnant women's rights to informed consent and bodily integrity. The "unkindest cut of all," (1) it seemed, had been condemned by the courts. (2) Yet shortly before the twenty-year anniversary of this landmark case, the same rights were stripped from another young pregnant woman. In January of this year, oral arguments were heard in the case of Samantha Burton. She had been twenty-five weeks pregnant in March 2009 when she developed signs of a potential premature birth. She was also a smoker. Her doctor ordered her to quit smoking immediately and to enter a hospital for bed rest. Burton wanted a second opinion and declined to be admitted to the hospital; she had two jobs and two young children at home, making bed rest problematic at best. Her doctor then contacted the state. According to the New York Times, Ms. Burton was "ordered to stay in bed at Tallahassee Memorial Hospital and to undergo 'any and all medical treatments' her doctor, acting in the interests of the fetus, decided were necessary. Burton asked to switch hospitals and the request was denied by the court, which said 'such a change is not in the child's best interest at this time.' After three days of hospitalization, she had to undergo an emergency C-section and the fetus was found dead." (3) Taken together, these cases indicate a worrisome lack of progress with respect to the personhood and rights of women when pregnant. Remarkably, the Burton case came to court almost exactly twenty years after the rendering of an appellate decision in the Carder case, thought by many to have established a clear precedent for protecting the rights of pregnant women in this situation. In the Carder case, decided on April 26, 1990, an appellate court in Washington, D.C., overturned a lower court ruling that had permitted the hospital to supersede Carder's refusal of cesarean section. (4) Though a victory for her family, the decision came too late for the patient. Angela Carder, twenty-seven years old when she gave birth, was in the second year of remission from bone cancer when she conceived. Midway through her pregnancy, though, the cancer recurred in her lung. All sides in the Carder case agree that Angela's stated desire was to do everything to prolong her own survival but not to accept interventions for fetal indications before the fetus reached twenty-eight weeks of gestation. Unfortunately, between twenty-five and twenty-six weeks gestation, her condition deteriorated and she became critically ill. The fetus's condition also appeared worse, and its demise seemed imminent. The family was asked if they wanted a cesarean section performed for the sake of the fetus, even though this intervention might further shorten Angela's life and would certainly add to her discomfort in her final days. In accordance with Angela's wishes, the family decided against surgery, and her obstetrician acceded to the family's request. A hospital attorney, however, felt that fetal interests needed stronger consideration, despite the fact that the fetus was at twenty-six weeks gestation in an era when survival at that age (let alone intact survival) was uncommon even when the mother was well. In the end, the judge ordered that the cesarean section go forward. The operation was performed, followed in short order by the infant's death and that of its mother. What happened to Angela Carder was not unheard of at that time. In fact, an article published two years earlier had detailed many cases of "forced" cesarean sections, as well as a pervasive belief among obstetricians that such procedures were justified. (5) It also revealed a worrisome profile of the women whose right to consent had been abrogated by court orders: they tended to be poor minority women who often didn't speak English. …

Determining approach to delivery after a previous cesarean is among the most contentious areas of obstetrics. We present a framework for ethically responsible guidelines and practice regarding vaginal birth after cesarean. We describe ethical complexities of 3 key issues that mark the debate: the cesarean delivery rate, safety, and patient autonomy. We then describe a taxonomy of considerations that should inform a responsible framework for guideline development and highlight critical distinctions between types of guidelines that have been blurred in the past. We then forward 2 central claims. First, in otherwise uncomplicated birth after a single previous cesarean, both vaginal birth after cesarean and repeat cesarean should be regarded as reasonable options; women, rather than policymakers, providers, insurance carriers, or hospitals, should determine delivery approach. Second, in complicated cases, providers and policymakers should carefully calibrate the strength of evidence to ensure differential risk and cost are adequate to justify directive guidelines given important variations in values women bring to childbirth.

Ethical decision making in women's health presents a series of unique challenges that are exacerbated considerably in under-resourced settings. Severe constraints on both autonomy and resources highlight limitations of principle-based ethics for addressing ethical dilemmas. Other useful ethical "tools" are considered in the context of 2 cases that emphasize the challenges to ethical decision making in under-resourced settings. The cases confront traditional notions of patient autonomy, highlight pervasive issues with regard to allocation of resources, and demonstrate the difficulties encountered in the careful application of medical ethics.

Reasoning well about risk is most challenging when a woman is pregnant, for patient and doctor alike. During pregnancy, we tend to note the risks of medical interventions without adequately noting those of failing to intervene, yet when it’s time to give birth, interventions are seldom questioned, even when they don’t work. Meanwhile, outside the clinic, advice given to pregnant women on how to stay healthy in everyday life can seem capricious and overly cautious. This kind of reasoning reflects fear, not evidence.

With a $3 billion investment by the federal government, the National Children's Study (NCS) recently began recruitment. The NCS is a golden—and potentially missed—opportunity to study one of the most underrepresented populations in clinical research: pregnant women. As the nation's largest-ever study of children's health, the NCS will examine the effects of the environment on children from before birth to 21 years of age, with participants sampled primarily through women during pregnancy. Thus the NCS presents a rare opportunity to study the health of women during and after pregnancy, in addition to the health of their children. On both moral and policy grounds, we make the case for inclusion of women's health outcomes in the NCS.

Patients making difficult choices among therapeutic options often ask their physicians what they would do if they were in the same situation. When faced with that question, physicians might be concerned that a direct answer could infringe on a patient's autonomy by substituting the physician's unique worldview or experience for their patients'. However, refusing to answer the question might lead a patient to feel unsupported at a difficult time. In this article we describe an approach that allows a physician to contribute to the patient's decision without inadvertently being coercive. That approach requires physicians to meaningfully shape therapeutic options, and assist patients in making difficult decisions. It is dependent on the physician being aware of the role of both their patients' values, and health values (eg, autonomy, futility) in decision making. It also requires an awareness of the force of language, both stated and implied, in shaping a patient's choice. To make a good decision, women need more than accurate information. They also need to be supported and sense empathy and understanding from their physicians and feel cared for. Although the facts (benefits and harms related to any given choice) are a necessary component of counseling, without discussion of values, they do not lead to a truly informed decision.