Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access (...) to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research. (shrink)

At no time in recent decades has more attention been paid to ethical issues in pregnancy. Particularly riveting—and alarming, to many—was the passage of Senate Bill 8, a Texas law banning abortion...

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. (shrink)

“It's almost like putting salt in a wound, for this person who's already made a very difficult decision,” suggested Meghan Patterson, a licensed obstetrician-gynecologist whom we interviewed in our qualitative study of the experiences of North Carolina abortion providers practicing under the state's Woman's Right to Know Act. The act requires that women receive counseling with state-mandated information at least twenty-four hours prior to obtaining an abortion. After the law was passed, Patterson worked with clinic administrators, in consultation with a (...) lawyer, to write a script to be used in the state-mandated counseling procedure. She and her colleagues took particular steps to mitigate the effects of what she described as HB 854's “forced language”—such as referring to the “father of the child.” While HB 854 stipulated that patients must be informed of the medical risks associated with the particular abortion procedure as well as those of carrying the child to term, Patterson's script made explicit the magnitude of comparative risks, emphasizing that the risks of carrying a pregnancy to term are substantially greater than the risks of an early-term abortion. She felt that these contextualization strategies helped to facilitate trust and rapport in a clinical care situation that proved relationally and morally challenging. In this article, we take up and expand on this point by elucidating an empirically grounded approach to ethically justified care when health care providers face legal or institutional policy mandates that raise possible moral conflicts. Our approach builds on recent bioethics discourse addressing conscience in the practice of medicine. While the concept of conscience has broad philosophical underpinnings relating to moral judgment, agency, and discernments of right and wrong, debates in bioethics have tended to engage the concept primarily vis-à-vis rights of conscientious objection or refusal. Here, we suggest a broader frame for thinking about claims of conscience in health care. Our approach draws on the feminist bioethics and the ethics of care literatures to highlight how providers may be motivated by matters of conscience, including relational concerns, in the active provision of certain forms of care. What emerges are two possibilities: not only conscientious refusal to comply with a policy mandate but also conscientious compliance—working conscientiously within a mandate's confines. (shrink)

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 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. (shrink)

In recent years, critics of modern obstetrics have cited technology as responsible for women's discontent regarding childbirth. In this essay, I investigate and pry apart the connection between the quality of childbirth experience and technology. After identifying three factors considered constitutive of a ‘good birth,’ I demonstrate how technology can either facilitate or hinder each, but how dominant strains of birthing practice that reinforce female shame consistently undermine them all. It is not technology per se, but its sensitive application, which (...) may most effectively promote an optimal and affirming birth experience. (shrink)

In this paper, I reflect on an important article by Bob Veatch in the inaugural issue of the Hastings Center Report, entitled “Experimental Pregnancy.” It is a report and elegant analysis of the Goldzieher Study, in which nearly 400 women were randomized to receive hormonal contraception or placebo absent consent or disclosure about placebo use, resulting in several pregnancies. Noting the study’s limited notoriety, I first consider the narratives that have instead dominated bioethics’ approach to pregnancy and research: thalidomide and (...) diethylstibesterol. These narratives have facilitated a narrow focus on avoiding fetal risk, to the exclusion of other ethically relevant considerations. I then revisit “Experimental Pregnancy” and offer two ways in which Bob’s analysis serves as an important corrective, first, by foregrounding research subjects, and second, by normalizing pregnancy and thus foregrounding foundational ethical considerations that are sometimes lost amidst pregnancy’s presumed exceptionalism. (shrink)

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 .. (shrink)

Background: Laws governing abortion provision are proliferating throughout the United States, yet little is known about how these laws affect providers. We investigated the experiences of abortion...

Feminist bioethicists have long shed light on the indignities and injustice of reproductive intrusions, be they coerced gestation or forced interventions during pregnancy and birth. Writing about t...

: In recent years, critics of modern obstetrics have cited technology as responsible for women's discontent regarding childbirth. In this essay, I investigate and pry apart the connection between the quality of childbirth experience and technology. After identifying three factors considered constitutive of a 'good birth,' I demonstrate how technology can either facilitate or hinder each, but how dominant strains of birthing practice that reinforce female shame (hospital-based obstetrics and midwifery) consistently undermine them all. It is not technology per se, (...) but its sensitive application, which may most effectively promote an optimal and affirming birth experience. (shrink)

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. (shrink)

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. (...) It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)

Prenatal ultrasound use is skyrocketing despite limited evidence of improved outcomes. One factor driving this trend is the widely recognized psychological appeal of real-time fetal imaging. Meanwhile, considering imperfect safety evidence, U.S. professional guidelines dictate that prenatal ultrasound—a screening test—should be governed by expected clinical benefits—an opportunity for intervention. However, when women’s healthcare professionals themselves are pregnant, their access to ultrasound technology permits informal, personal use that may deviate from standard-of-care, e.g., for reassurance. Highlighting a poignant case wherein a pregnant (...) obstetrician’s personal ultrasound use had unforeseen negative consequences, we explore this issue within context of professional ethics and informal medical care. We discuss how women’s health professionals’ self-care may influence and inform prenatal care at large. We advocate curtailing informal prenatal ultrasound use, but also potentially broadening accepted indications for or relaxing proscriptions against ultrasounds for patients. Further research and updated, evidence-based, ethically-sound guidelines are needed. (shrink)

In recent years, tremendous progress has been made toward recognizing the need for improved medical knowledge for pregnant people, a population group that has long been excluded from clinical trial...

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. (shrink)

Bioethics, Volume 36, Issue 9, Page 999-1000, November 2022.