Smajdor and Rasanen (2024) argue that pregnant women are routinely denied appropriate treatment because pregnancy is seen as normal, and so they are denied ‘patient status’. They claim that formally classifying pregnancy as a disease may lead to better treatment for pregnant women. In this response, we argue that pathologising pregnancy and classifying all pregnant women as ‘diseased patients’ won’t reconfigure care in ways that benefit all women. Rather, it will likely only embolden (...) the view that clinicians are entitled to exercise jurisdiction over pregnant women and beget the increased use of medical intervention where it is not necessarily needed. (shrink)

Many women are initially unable to contract the pelvic floor muscles (PFMs) properly, activating other muscle groups before, or instead of, PFM. Numerous authors have proved that biofeedback can be an ideal tool supporting learning of the PFM contraction. However, there is currently a lack of scientific data on how many biofeedback sessions are necessary in this educational process. In this study we aimed at assessing the effects of one-time electromyography (EMG) biofeedback session on the order in which PFM (...) are activated (so called firing order) during conscious contractions in relation to selected synergistic muscles in pregnant, continent women. A randomized controlled trial was conducted in 90 healthy nulliparous women with uncomplicated pregnancies and without diagnosed urinary incontinence. We divided the participants into a biofeedback group (50) and a control group (40). They were, respectively: 30 ± 4 and 30 ± 4 years old, at their 23 ± 5 or 25 ± 7 week of gestation and presented 23 ± 5 or 24 ± 5 kg/m2 BMI value (M + SD). Surface EMG with vaginal probes has been used to assess the PFM firing order in selected tasks: in five 3-s maximal contractions (quick flicks), five 10-s contractions, and in a 60-s contraction (static hold). We used the 1–5 scale, where “1” meant the best score, awarded when PFM was activated first in order. The most important finding of our study is that a single EMG biofeedback substantially improved the PFM contractions in pregnant women. First, when applying one-time biofeedback session, more women maintained correct technique or improved it in the second assessment, compared to the control group (73 vs. 65%). Secondly, using the quantitative and qualitative analysis with the Chi-square McNamara B/C test, in the biofeedback group we observed a statistically significant improvement of PFM firing order in four tasks: in the first quick flicks (p = 0.016), third quick flicks (p = 0.027), fifth quick flicks (p = 0.008), and in the first 10-s contractions (p = 0.046). In the control group we observed better outcome only in one motor task: in the fourth 10-s contraction (p = 0.009). Given the positive effects of a single session of EMG biofeedback on the firing order in the PFM contractions, it should be recommended for pregnant women without urinary incontinence to teach them how to perform PFM exercises correctly. (shrink)

BackgroundPhysical activity is known to improve mental health, and is regarded as safe and desirable for uncomplicated pregnancy. In this novel study, we aim to evaluate whether there are associations between maternal physical activity during pregnancy and neonatal brain cortical development.MethodsForty-four mother/newborn dyads were included in this longitudinal study. Healthy pregnant women were recruited and their physical activity throughout pregnancy were documented using accelerometers worn for 3–7 days for each of the 6 time points at 4–10, ∼12, ∼18, (...) ∼24, ∼30, and ∼36 weeks of pregnancy. Average daily total steps and daily total activity count as well as daily minutes spent in sedentary/light/moderate/vigorous activity modes were extracted from the accelerometers for each time point. At ∼2 weeks of postnatal age, their newborns underwent an MRI examination of the brain without sedation, and 3D T1-weighted brain structural images were post-processed by the iBEAT2.0 software utilizing advanced deep learning approaches. Cortical surface maps were reconstructed from the segmented brain images and parcellated to 34 regions in each brain hemisphere, and mean cortical thickness for each region was computed for partial correlation analyses with physical activity measures, with appropriate multiple comparison corrections and potential confounders controlled.ResultsAt 4–10 weeks of pregnancy, mother’s daily total activity count positively correlated (FDR corrected P ≤ 0.05) with newborn’s cortical thickness in the left caudal middle frontal gyrus (rho = 0.48, P = 0.04), right medial orbital frontal gyrus (rho = 0.48, P = 0.04), and right transverse temporal gyrus (rho = 0.48, P = 0.04); mother’s daily time in moderate activity mode positively correlated with newborn’s cortical thickness in the right transverse temporal gyrus (rho = 0.53, P = 0.03). At ∼24 weeks of pregnancy, mother’s daily total activity count positively correlated (FDR corrected P ≤ 0.05) with newborn’s cortical thickness in the left (rho = 0.56, P = 0.02) and right isthmus cingulate gyrus (rho = 0.50, P = 0.05).ConclusionWe identified significant relationships between physical activity in healthy pregnant women during the 1st and 2nd trimester and brain cortical development in newborns. Higher maternal physical activity level is associated with greater neonatal brain cortical thickness, presumably indicating better cortical development. (shrink)

Smoking is frequently presented as being particularly problematic when the smoker is a pregnant woman because of the potential harm to the future child. This premise is used to justify targeting pregnant women with a unique approach to smoking cessation including policies such as the routine testing of all pregnant women for carbon monoxide at every antenatal appointment. This paper examines the evidence that such policies are justified by the aim of harm prevention and argues (...) that targeting pregnant women in this way is likely to do more harm than good. Routine carbon monoxide testing is particularly problematic as it sends a message to pregnant women that they cannot be trusted either to truthfully answer questions as to whether or not they smoke, or to make decisions in the best interests of themselves and their future children in the way that non-pregnant individuals are. Further, if the aim is to reduce rates of prenatal harm, the evidence suggests that adopting a supportive and empowering approach to prenatal care is the most effective way to achieve this, something that the current policies aimed at pregnant women are in conflict with. (shrink)

In research involving pregnant women and fetuses, a number of questions arise concerning the balancing of risks and benefits. In research that holds out a prospect of direct benefit for the woman, how much risk to the fetus is permissible? How should the principle of minimizing risks be applied when there are two subjects—pregnant woman and fetus? Should risks for each of them be minimized? What if minimizing risks for one increases risks for the other? These and (...) other questions are not addressed in the current federal regulations for the protection of human subjects. This paper reviews the current regulations, attempts to identify issues that need to be addressed, considers alternative viewpoints concerning those issues, and argues for particular views. It concludes with a set of proposed guidelines for balancing risks and benefits in research involving pregnant women and fetuses. (shrink)

A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is (...) inappropriate and disrespectful.2–4 There is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)

Background: Although maternal serum screening for Down’s syndrome has become routinely available in most obstetric clinics in many countries, few studies have addressed the reasons why women agree to undergo the MSS test.Objectives: The aims of this study were to describe the circumstances in which MSS was offered to pregnant women and their reasons for undertaking it.Methods: Participant observation and in depth interviews were used in this study; specifically, the experiences of women who had a positive (...) result for MSS and who then followed this up with amniocentesis were examined. The interviewees were twenty six mothers aged between 22 and 35 years. The interviews were audio taped and transcribed for analysis. The results were analysed by the constant comparative method.Results: This study identified the reasons on which pregnant women appeared to base their decisions when undergoing MSS. The reasons were first, the recognition that the procedure was a prenatal routine procedure; second, the need to avoid the risk of giving birth to a baby with Down’s syndrome, and third, a trust in modern technology and in the professional authorities.Conclusions: This study offers insights into the informed choice made by women with a positive MSS result. The reasons for undergoing MSS might help health professionals and policy makers to reflect on their practice and this may, in turn, improve the quality of prenatal care during MSS. (shrink)

Photo by Alex Guillaume on Unsplash Introduction The problem of climate change raises some important philosophical, existential questions. I propose a radical solution designed to provoke reflection on the role of humans in climate change. To push the theoretical limits of what measures people are willing to accept to combat it, an extreme population control tool is proposed: allowing people to reproduce only if they make a financial commitment guaranteeing a carbon-neutral upbringing. Solving the problem of climate change in the (...) long run by halting the procreation of human beings is controversial. In the absence of human beings and consequent climate change, other animals and plant species would benefit from an atmosphere more conducive to prolonging their existence and even improving their ability to thrive. If someone were to invent something to reverse the effects of climate change and improve animals’ lives, then human beings’ presence would be justified by the invention. Whether the propagation of the human species is beneficial to anyone or anything but human beings themselves is difficult to answer. Perhaps human beings are unfit to tackle this issue, being unable to judge it objectively. Managing Procreation: An alternative to Piecemeal Approaches Measures aimed at reducing greenhouse gases by nudging individuals and corporations may have a positive effect, but if their behavior is not climate neutral, they continue to contribute to climate change. Consequently, as long as the number of people increases, reducing greenhouse gases is at best a mitigation tool. If humans could rely solely on renewable energy, decreasing the population arguably would not be necessary. Significantly reducing the number of people appears to provide a solution to both problems: people who do not exist do not contribute to climate change, and renewable energy could meet the demand of a smaller population. One option is to let only those who produce the problem pay for its solution. One could determine the expected annual emission of greenhouse gases per person, assuming an average life expectancy, and calculate the costs to compensate them by, e.g., installing extra solar panels. Those expected costs could then be paid by the parents of each new person annually over the first eighteen years of that person’s life by dividing the total expected costs by eighteen. There are also practical difficulties. It would be difficult to determine the payment necessary. What should be done if a child has been born whose parents cannot afford to pay? In addition, child benefits could be canceled, contrary to recent incentives for child births instated in Italy,[1] where additional benefits will be made available to pay for childcare, and Hungary,[2] where women with four children or more will be exempted for life from paying income tax. A transition period could exist once the policy has been adopted, since it would be unreasonable to confront those who are already pregnant with costs they could not reasonably have expected. While the analysis is both hypothetical and theoretical, the impracticality is a noteworthy obstacle. There are several practical issues that cannot be addressed here, like the difficulty of calculating the added negative effects of each new individual and the unlikelihood that many citizens will support politicians who propose adopting policies that discourage having children. The upshot of what I have proposed is that climate change can be solved in the long run without financial costs to society as a whole, notwithstanding the transitional measures that would bring costs with them. Managing Procreation to Reduce Suffering Should this be deemed too harsh a stance, it is important to consider the basic issue of whether it is justified to introduce measures to reduce the number of people in an already overpopulated world, especially if climate change leads to additional suffering. One need not agree with Benatar, but his perspective must at least be taken seriously: It is curious that while good people go to great lengths to spare their children from suffering, few of them seem to notice that the one guaranteed way to prevent all the suffering of their children is not to bring those children into existence in the first place.[3] Benatar argues that non-existence is preferable to existence,[4] which raises the question why new people should be created at all. Those who question whether this planet will be habitable for future generations presuppose that such generations will exist. If people are not brought into existence, they may be said to be deprived of what life has to offer, but life must not be presupposed to be something positive. Whether this is the case in fact merits an inquiry of its own. A solution to the problem of climate change despite an increased population does not equate to a positive outcome since it merely means that something negative is removed. After all, solving the problem is not a means to an end, but a means to a means, the latter means being a means to a happy life, which does not automatically ensue from a solution to the problem. Benatar, as an anti-natalist, argues that procreation is morally wrong. His basic idea is that there is an asymmetry between pleasure and pain and that the pleasure that is not experienced by someone because that person does not exist is not something bad whereas the absence of pain that is not experienced – for the same reason – is something good.[5] Accordingly, “The reason why we do not lament our failure to bring somebody into existence is because absent pleasures are not bad.”[6] One may question whether such a perspective suffices to prove that coming into existence is always a harm, but the assertion that coming into existence exposes a new being to potential harm is clear. Objections A drawback of the proposed radical solution, placing the financial impediment on procreation, is that it will not solve climate change in the short run. A significant drop in the number of people may have a positive effect in the long run, but for now the behavior of the people in existence is the problem. Other climate change mitigation policies would necessarily continue. Additionally, there are important practical reasons to continue to procreate. The benefits for the elderly are paid for by the labor force. It is a problem that new generations are created as mere means to benefit older people. Perhaps more troubling, a pyramid scheme is created: by the time those people have themselves become old, a new labor force must have been brought into existence, a process that must presumably continue. If a consideration for people in developing countries to have children is that they cannot provide for themselves at an advanced age, while benefits are either lacking or insufficient, developed countries could collectively fund a pension scheme.[7] This may be low-cost if it is tailored to the living standard in the countries in question and given the life expectancy. Such a pension scheme should be predicated on the countries’ efforts in reducing the birth rate. If the labor force decreases, the economy may suffer. The focus on economic growth is arguably one of the causes of climate change, but if the number of people is reduced, the living standard does not have to be compromised, since the economy can then still grow. If fewer people began to use natural resources and nonrenewable energy at higher per capita rates, then the procreation might not be beneficial to the climate. It would need to be accompanied by regulations on use. One may also object that only wealthy people will be able to afford children. This is correct, but there is no right to have a child one cannot afford. The right to procreate does not entail the right to have as many children as one wants.[8] Yet in many countries, like the United States, it is a fundamental right that is constitutionally protected. There are numerous social, emotional, and even biological reasons why people choose to procreate. These may include the joy of having a family, the hope that children may bring in society, and the intergenerational transference of knowledge. People may have a strong desire to raise children or even a religious duty. If someone procures a sports car that is highly polluting, it would be justifiable to impose a tax in such a case. Many taxes and fines are imposed on corporate polluters. Procreation is significantly different but if the issue is regarded with some distance, then a climate change prevention tax could be appropriate. Some may argue that raising children is expensive already, which nonetheless does not deter people from having children. The tax I propose would be additional and specifically dedicated to carbon neutrality, but it would be difficult to predict whether it would discourage procreation. One last objection may be that for those now dedicated to sustainability for preserving the earth for the sake of future generations, there would be little or no incentive to continue any climate change mitigation efforts at all. If they sense they cannot afford to procreate, they may simply use every natural resource rather than save the earth for animals or for next generations. In a democracy, this problem does not exist if the majority can afford to procreate and agree with legislation on the basis of which such behavior is discouraged or punished. CONCLUSION Prior to their existence, there is no obligation to bequeath the earth to next generations. Such generations will only exist if they are actually created, and there is no obligation to create them. The lack of existence should not be confused with harm. Climate change provides an important reason to stem overpopulation. Ironically, fast rates of procreation may lead to the earth becoming uninhabitable for humans altogether. The radical solution that has been proposed here is an unrealistic scenario. For now, the average global birth rate is just over 18 per thousand people, but there is a need to ensure that the number of people is not greater than the planet can endure. While it is better to prevent problems than to solve them, the interest in procreation and its associated joys, usefulness, and cultural value make mass reduction in the population unlikely. Some countries have smaller average family size than others and can act as models for reducing population in a less radical way. The need to continue efforts to reduce climate change persists. Whether it would curb population growth or not, an additional financial burden applied to neutralizing each person’s offspring’s carbon footprint provides a meaningful thought exercise that could help alleviate the pressure on current climate mitigation strategies. [1] The Local Italy, How Italy’s new ‘Family Act’ aims to increase the plunging birthrate, https://www.thelocal.it/20200612/what-you-need-to-know-about-italys-new-family-act/. [2] BBC, Hungary tries for baby boom with tax breaks and loan forgiveness, https://www.bbc.com/news/world-europe-47192612. [3] David Benatar, Better never to have been, 6. [4] David Benatar, Better never to have been, 44, 58. [5] David Benatar, Better never to have been, 14, 30, 38. [6] David Benatar, Better never to have been, 35. [7] Alastair Leithead, “Can Niger break out of its cycle of poverty?”, https://www.bbc.com/news/world-africa-41018081; Sebastien Malo, “Fewer children, fewer climate risks? Niger ponders a controversial option”, https://www.reuters.com/article/us-niger-climate-change-familyplanning-idUSKBN1WM11E. [8] Sarah Conly, “The Right to Procreation: Merits and Limits,” American Philosophical Quarterly 42, no. 2 : 105-115, 105, 106. (shrink)

This study appeared in full in the last issue of Research Ethics Review (2007; 3(1): 18). Rowena Jones is an obstetrician working in a busy hospital for women. Her research focuses on changes in women's brains during pregnancy1. Rowena plans to use magnetic resonance imaging to record images of the brains of women in the second and third trimesters and after birth at 6 and 24 weeks. Her sample consists of two groups of healthy women with (...) uncomplicated and singleton pregnancies, the first primigravid and the second multiparous. There will be a minimum of five and a maximum of ten women in each group. (shrink)

Contrary to spontaneous yawning, which is widespread in vertebrates and probably evolutionary ancient, contagious yawning—yawning triggered by others’ yawns—is considered an evolutionarily recent phenomenon, found in species characterized by complex sociality. Whether the social asymmetry observed in the occurrence of contagious yawning is related to social and emotional attachment and may therefore reflect emotional contagion is a subject of debate. In this study we assessed whether yawn contagion was enhanced in pregnant women, a cohort of subjects who develop (...) prenatal emotional attachment in preparation for parental care, via hormonal and neurobiological changes. We predicted that if yawn contagion underlies social and emotional attachment, pregnant women would be more likely to contagiously yawn than nonpregnant, nulliparous women of reproductive age. We gathered data in two different settings. In the experimental setting, 49 women were exposed to video stimuli of newborns either yawning or moving their mouth and we video-recorded the women during repeated trials to measure their yawning response. In the naturalistic setting, 131 women were observed in a social environment and their yawning response was recorded. We tested the factors influencing the yawning response, including the reproductive status. In both settings, yawn contagion occurred significantly more in pregnant than nonpregnant women. By showing that pregnant women were most likely to respond to others’ yawns, our results support the hypothesis that the social variation observed in yawn contagion may be influenced by emotional attachment and that yawning in highly social species might have been coopted for emotional contagion during evolution. (shrink)

ObjectivePregnancy leads to long-lasting changes in brain structure for healthy women; however, little is known regarding alterations in the cortical features of pregnant women with malformed fetuses. Isolated clefts of the lip and/or palate (ICL/P) are the most common congenital anomaly in the craniofacial region, which is highly gene-associated. We speculated that pregnant women carrying fetuses with ICL/P may have associated risk genes and specific brain changes during pregnancy.MethodsIn this study, we investigated T1-weighted brain magnetic (...) resonance imaging data from 48 pregnant women: 24 women carrying fetuses with ICL/P (ICL/P group) and 24 women carrying normal fetuses (normal controls), then explored intergroup differences in gray matter volume (GMV), cortical thickness (CT) and cortical complexity (gyrification).ResultsCompared with controls, the ICL/P group had decreased total intracranial volume (TIV) than normal controls; besides, they exhibited increased GMV in the left cuneus, decreased GMV in the right superior temporal gyrus; increased CT in the left precuneus and left superior parietal gyrus, decreased CT involving parsopercularis, fusiform, middle temporal in the left hemisphere and supramarginal, precentral gyrus (PreCG) in the right hemisphere; increased gyrification in the left insula and PreCG, the left middle temporal, and the right supratemporal gyrus.ConclusionPregnant women with ICL/P fetuses had brain morphology changes involving language, auditory, vision, and sensory cortex, which may be their special brain changes compared to normal pregnant women. This study may provide clues for the early detection of fetuses with ICL/P, and be vital for preconception and prenatal counseling with non-invasive methods. (shrink)

of (from Oxford Uehiro Centre for Practical Ethics) Medical Journal of Australia, 188 (2) 100 - 102.

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial (...) component to ensuring effective recruitment. The Research In Pregnancy Ethics study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage. (shrink)

The introduction of non-invasive prenatal testing in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to pay for NIPT. In this paper, we discuss two important rationales for charging women for NIPT: to prevent increased uptake of NIPT and to promote informed choice. First, given the aim of prenatal screening, high or low uptake rates are (...) not intrinsically desirable or undesirable. Using funding policies to negatively affect uptake, however, is at odds with the aim of screening. Furthermore, copayment disproportionally affects those of lower socioeconomic status, which conflicts with justice requirements and impedes equal access to prenatal screening. Second, we argue that although payment models may influence pregnant women’s choice behaviours and perceptions of the relevance of NIPT, the copayment requirement does not necessarily lead to better-informed choices. On the contrary, external influences on women’s personal choices for or against prenatal screening should ideally be avoided. To improve informed decision-making, healthcare systems should instead invest in adequate non-directive, value-focused pretest counselling. This paper concludes that requiring copayments for NIPT in universal access healthcare systems fails to promote reproductive autonomy and is unfair. (shrink)

The integrated model of mental health recommends nowadays the collaboration between psychiatrists, psychotherapists and clinical psychologists. It is currently the agreed model in the managed health care system in the West and research has shown that mixing the medical model with the psychological model both in theory and practice elicits the best outcomes and guides the client towards recovery. In this paper I will challenge this view on a particular area of psychopathology, mild and moderate depression and anxiety, showing that (...) in these particular situations, 15-20 sessions of psychotherapy are sufficient and efficient for recovery and there is no further need for medicating the client, unless the client himself desires this particular type of psychiatric approach. I will also focus on a target group, pregnant women who fear toxic reactions for the fetus and don’t consider taking antidepressant and anxiolytic medication out of fear of adverse reactions. I will also explore the ethical implications of prescribing these target groups medication against their will. CBT, REBT and Existential Psychotherapy are effective options to treat both the symptoms and causes of mild and moderate anxiety and depression, whilst exercise, nutrition and mindfulness meditation can also be effective treatments. Since medications such as antidepressants have recently become the treatment of choice in United States with a 147.5% increase in antidepressant prescription rates between 1990 and 1998 and with a 10.9% decrease in the utilization of psychotherapy, my paper aims to balance this approach in the favour of psychotherapy as a first choice option. (shrink)

Death of motor neurones following invasion of the central nervous system by poliovirus may result in paralysis of specific muscles. Virulence may be tested by injection into monkeys by routes which bypass natural infection. Transmissibility is also very important, but cannot be measured, only inferred. An infection may lead to immunity or paralysis. In epidemics, the highest incidence among children 0-2 years was 2% and among those over 10 years was 25%: these figures fit a model of genetic susceptibility of (...) homozygotes and heterozygotes with phenotypic susceptibility increasing with age. Hypogamma-globulinemics, some neonates and pregnant women are more susceptible than others. Intra-muscular injections may increase the risk of paralysis. Strenuous exercise and IM injections given when poliovirus has already reached the spinal cord can increase the severity of paralysis or convert a non-paralytic attack to paralysis. Although vaccines reduced polio in temperate countries, polio was thought to be no problem in the tropics. Since 1977 polio has been recognised as a massive problem in the third world: because it affects babies and very young children, it is properly infantile paralysis. (shrink)

The maternal‐fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki – the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the (...) controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow ‘local conditions’ to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta‐ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects. (shrink)

In this article the results of a study of psychological readiness of pregnant women to parenthood are presented. Psychological readiness is defined as a structure consisting of three components: the cognitive, emotional, and behavioral, which is consistent with the single theory of psychological processes L. M. Vekkera. It was found that the main component that determines the high level of psychological readiness for motherhood is a cognitive component. The content of the cognitive component includes an understanding of the (...) child as a value. Some results of the research of value orientations of pregnant women in the structure of psychological readiness for parenthood. To identify the value system of pregnant women, the method of ‘Value Orientations‘ by M. Rokich was applied. The analysis of empirical data was performed using factor analysis and U criterion of Mann-Whitney. Respondents were distributed into two age groups: first group of 21-25 years, second group of 26-30 years. All women are nulliparous. The younger age group of pregnant women is characterized by values that are directed at the outside world. Emotional component dominates in the structure of psychological readiness for motherhood. Values of women in the second group are aimed at children. Cognitive and behavioral components dominate in the structure of their psychological readiness for motherhood. Knowledge of the structure of psychological readiness of women to parenthood will help to diagnose disorders of maternal behavior, to design methods of its correction and prevention. (shrink)

BackgroundSolution-focused model is an intervention method that fully mobilizes patients’ initiative through their potential. We aimed to investigate the effects of SFM on anxiety and postpartum depression in nulliparous pregnant women compared with routine care services.MethodsWe chose the mothers diagnosed as depressed or with depressive tendency by Edinburgh Postpartum Depression Scale at 28 weeks of gestation and divided them into the intervention and control groups. The control group only took the routine pregnancy healthy nursing, while the SFM group (...) took the regular nursing and SFM counselling. Different assessments were conducted at 28 weeks of gestation, post-delivery, and post-intervention to evaluate the anxiety and depression levels of the patients. Finally, nursing satisfaction was evaluated by the nursing satisfaction questionnaire.ResultsCompared with the control group, SFM could decrease the scores of anxiety and depression more effectively and influence sleep quality more positively. We also found that SFM resulted in significantly higher nursing satisfaction than that in the control group.ConclusionIn conclusion, SFM could effectively alleviate anxiety and PPD in nulliparous pregnant women. (shrink)

Abstract:This article analyzes the pervasive practice in US carceral institutions of shackling incarcerated pregnant women during childbirth and postpartum. After a review of bioethical, civil, and human rights norms, which widely condemn the practice, I advance an interpretation of the social meaning of shackling imprisoned pregnant women and its persistence despite widespread normative consensus in favor of its abolition. Two arguments regarding the persistence of the practice are considered: (1) that it stems from the unthinking exportation (...) of prison rules to a hospital setting and (2) that it is the product of an androcentric approach to punishment and carceral health care ill-adapted to women’s needs. I argue that these explanatory frameworks are inattentive to the intersecting genealogies of race and gender that are constitutive of the practice. As a result, the prescriptive horizons that these frameworks delineate are inadequate to the race- and gender-specific task of redress. Drawing from Black feminist theory and Nietzsche, I argue that the practice of shackling imprisoned pregnant women, like many ostensibly race-neutral facets of American mass incarceration, is a sedimentation of slavery that impacts all incarcerated women. The practice is symptomatic of the persistent anti-Blackness of the criminal legal system and the unfinished project of American abolition. (shrink)

A decade of advocacy for the inclusion of pregnant women in the clinical research agenda is starting to pay off. In September, the United States Task Force on Research Specific to Pregnant Women and Lactating Women issued its advice to the secretary of Health and Human Services on addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The task force is pushing for major reforms. (...) If its recommendations are taken up, we can anticipate a significant shift in pregnancy research in the United States. This will affect pregnant women, clinicians caring for them, researchers, and institutional review boards. (shrink)

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)

Since the introduction of drugs to prevent vertical transmission of HIV, the purpose of and approach to HIV testing of pregnant women has increasingly become an area of major controversy. In recent years, many strategies to increase the uptake of HIV testing have focused on offering HIV tests to women in pregnancy-related services. New global guidance issued by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifically notes these services as an (...) entry point for provider-initiated HIV testing and counseling (PITC). The guidance constitutes a useful first step towards a framework within which PITC sensitive to health, human rights and ethical concerns can be provided to pregnant women in health facilities. However, a number of issues will require further attention as implementation moves forward. It is incumbent on all those involved in the scale up of PITC to ensure that it promotes long-term connection with relevant health services and does not result simply in increased testing with no concrete benefits being accrued by the women being tested. Within health services, this will require significant attention to informed consent, pre- and post-test counseling, patient confidentiality, referrals and access to appropriate services, as well as reduction of stigma and discrimination. Beyond health services, efforts will be needed to address larger societal, legal, policy and contextual issues. The health and human rights of pregnant women must be a primary consideration in how HIV testing is implemented; they can benefit greatly from PITC but only if it is carried out appropriately. (shrink)

To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used (...) participant observation, in‐depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner. (shrink)

SummaryThe Fair Intellectual Club was the earliest female intellectual sociability on record in Britain in the eighteenth century. A study of the club provides insights into the motivations for founding such a society. The reading list of the club contains some twenty pamphlets on a variety of subjects including the education of both sexes, friendship and moral issues. The particular question in mind while assessing these materials will be, as far as this club is concerned, what kind of philosophical understanding (...) of sociability inspired these ladies. The Fair Intellectual Club also provides a platform for discussion of questions about the identity, the responsibility, and the gender of learned persons, in addition to their role as active agents in the production of knowledge in the eighteenth century. (shrink)

Courts and legislatures are increasingly being called upon to restrict the autonomy of pregnant women by requiring them to behave in ways that others determine are best for the fetuses they carry. The state should not attempt to transform pregnant women into ideal baby‐making machines. Pregnant women make decisions about their behavior in the context of the rest of their lives, with all the attendant complexities and pressures. Our interest in helping future children by (...) improving prenatal care would best be furthered by helping pregnant women to make informed, less constrained choices, not by punishing women or depriving them of choices altogether. (shrink)

Despite the attempts to promote the inclusion of pregnant women into clinical research, this group is still widely excluded. An analysis of the “vulnerability of pregnant women” that questions deeply internalized stereotypes is necessary for finding the right balance in the protection of pregnant women as research participants. Criticism of the traditional account of vulnerability will lead to an alternative that focuses on situations rather than groups and on the obligations of responsible parties. The (...) paper adds to the current general discussion of vulnerability and at the same time addresses the specific problem of drug treatment during pregnancy. (shrink)

From the perspective of investigators conducting research involving pregnant women and fetuses, a woman's decision about whether to have an abortion can sometimes be relevant to the suitability of the woman and fetus as research subjects. However, prominent ethicists disagree over whether it is permissible for a woman's decision about abortion to be an inclusion or exclusion criterion for participation in research. A widely held view is that fetuses to be aborted and fetuses to be carried to term (...) should be treated equally as research subjects. Some hold that this principle implies that a woman's decision about whether to have an abortion should not be an inclusion or exclusion criterion. This paper identifies types of research in which investigators might want to have inclusion or exclusion criteria based on decisions about abortion. It examines the arguments for and against having the woman's decision about abortion included in such criteria. It is argued that there are types of research in which such criteria are ethically permissible. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:The Female in Aristotle’s Biology: Reason or RationalizationTony PreusRobert Mayhew. The Female in Aristotle’s Biology: Reason or Rationalization. Chicago: University of Chicago Press, 2004. Pp. xi +136. Cloth, $28.00.Aristotle's views on the ethical, social, and political roles of women have repeatedly drawn the attention of scholars. Often, the central focus of the discussion is Politics I.13, 1260 a13, where Aristotle says that although women have a (...) deliberative faculty, it is akuron, "without authority." A charitable (from our point of view) interpretation of that word would have him mean that women are capable of ethical and political decision-making, but fourth-century BCE Athenian social arrangements prevent their exercising that capacity outside the home. However, many readers of Aristotle suppose that he means to indicate a natural difference between men and women, some mental or moral inferiority of women. A few passages in the Politics support that interpretation (e.g., Pol. I.2, 1254 b13, 12.1259 a40), but those do not provide a "scientific" or "biological" grounding of female inferiority. That sort of thing one would expect to find in the biological works. Mayhew's monograph is an exposition of the errors and exaggerations of some of those writers, from the usually careful Martha Nussbaum to the usually unreliable Luce Iragaray.The least cautious critics of Aristotle's views on women typically fasten on his views on sexual generation; as Mayhew shows (ch. 3), such critics either claim that Aristotle believed that women contribute only a place for generation to occur, or that women contribute totally passive matter. Mayhew is able to demonstrate, rather easily, that either claim depends on total ignorance or total misunderstanding of the actual contents of the Generation of Animals. In Aristotle's opinion, the female provides proximate matter for the offspring, something that is almost able to develop into a new individual and needing only the impetus and form provided by the male contribution. Having started with the "form/matter" distinction, it is pretty obvious that the female provides the matter (a bird egg is all of the matter that goes to make the chick), and the male is necessary for reproduction to [End Page 109] occur, so it must be a source of movement (at least) and some element of form (since the offspring partially resembles its male parent) that comes from that source. (For older discussions of this issue, see my Science and Philosophy in Aristotle's Biological Works [Hildesheim, 1975], ch. 2, and J. Morsink, "Was Aristotle's Biology Sexist?" J. Hist. Biol.12 [1979]:83-112, neither noted by Mayhew). But what would be the ethical or political implications of that distinction? Aristotle says that it is "better" to provide form, but there's no straightforward way to conclude from that difference that a woman's deliberative faculty is less authoritative than a man's, any more than there is any straightforward way to argue from the fact that a woman might spend some time pregnant that a permanent pay differential is justified. And Aristotle does not try to make that sort of argument, as a matter of fact.Mayhew deals with most of the other arguments that some have derived from the biological works to support their view that Aristotle's "science" is the foundation of his (supposed) sexism. For example, he points out that although Aristotle does call "kings" the bees that we call "queens," he also calls the analogue among wasps the "mothers" or "wombs"; Mayhew says that Aristotle seems to have thought that the king/queen bee was hermaphroditic and parthenogenetic. Mayhew also has an original and interesting chapter on Aristotle's comparisons between women and eunuchs; although he notes that Aristotle was friendly with at least one eunuch, Hermeias, the uncle of Aristotle's young wife, he leaves out Aristotle's poetic praise of Hermeias (see R. Renehan, in Greek, Roman, and Byz. Stud.23 [1982]: 251-74). Suppose women were "eunuchoid" according to Aristotle, it couldn't mean that they were consequently intellectually inferior, since at least one eunuch was, in Aristotle's opinion, intellectually superior.Mayhew also discusses, adequately enough, the issues of brain... (shrink)

Dr de Zulueta articulates some important and commonly held concerns about the anonymised screening programme for HIV in pregnant women, which is one of a number of such programmes that are current. However, in my view, many of these concerns reflect a failure to understand two key distinctions.In both these regards, there is a danger of putting up a “straw man” for challenge. In this commentary, I wish to pick up some of these issues to help to resolve (...) the apparent ethical tensions that Dr de Zulueta has set out.Firstly, the unlinked seroprevalence surveillance programmes, including that on pregnant women, comprise research studies that are designed to inform policy and practice, as well as individual decision making. They are not screening for the purpose of clinical care. The anonymisation is a procedural research tool, which enables the studies to be done in a way that does not undermine consent or individual autonomy. The ethical standards and duties expected of professionals are thus, in this specific regard, those that relate to the conduct of clinical research. That research is evidently designed to improve the quality of clinical care as a result of the information and insight gained. The duty of care is to apply the results of properly conducted and valid research in order to improve clinical practice on behalf of the individuals receiving care, in this case the mother and unborn child. The research conducted, in this case by a particular form of screening procedure, is not the same as a screening procedure done for clinical purposes to identify individuals who could benefit from an intervention. The ethical debate must therefore focus on the purpose in applying the procedure, not on the procedure itself, regardless of intent.Secondly, it is vital to distinguish, in debating such …. (shrink)

Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22 women enrolled in either one of two trials sponsored by the National Institutes of Health to assess the safety and immunogenicity of the H1N1 vaccine during pregnancy. Three themes characterized women’s decisions to participate in research: they valued early access to the vaccine, they perceived a (...) safety advantage when participating in research, and they wanted to help advance scientific knowledge. However, there were also some considerations that would disincline them to participate in research—for instance, a significant risk of maternal or fetal harm, the presence of a placebo arm in a study, or a requirement to significantly change planned therapy or behavior. Pregnant women who participated in the H1N1 vaccine trials viewed research favorably, citing its advantages over standard clinical care. These findings emphasize that access to benefit should guide policy for including pregnant women in research. (shrink)

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a (...) low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing in a (...) clinical setting. We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions. (shrink)

There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence...

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies (...) of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.The concept of minimal risk is defined in the regulations as follows:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (shrink)

Purpose: The purposes of this study were to investigate the relationship between dental anxiety amongst pregnant women and their dental attendance patterns, considering various sociodemographic factors, at health centers in the Kingdom of Saudi Arabia. Materials and Methods: Participants in this cross-sectional descriptive study were 386 pregnant women seeking care at Saudi Ministry of Health centers. A validated version of the Modified Dental Anxiety Scale (MDAS) was used to measure dental anxiety. Questionnaires including background data and (...) dental anxiety were used and clinical data were collected. The association between oral health literacy and dental anxiety was evaluated with Spearman’s correlation coefficient. A multiple linear regression model with dental anxiety (MDAS score) as the dependent variable was developed to investigate further the relationship dental anxiety amongst pregnant women and their dental attendance patterns. Results: The prevalence of dental anxiety was very anxious (3.595). According to a multiple binary logistic regression model, previous experiences with dentists, household income, educational level, number of times and months of pregnancy, and the perception that oral care should be avoided during pregnancy were independently associated with dental anxiety. Conclusions: Dental anxiety in pregnant women is linked to social and psychological factors, in addition to oral health. Specifically, prior experiences with dentists, attitudes toward dental care, and general fear appear to have the strongest influence on dental anxiety. The prevalence of dental anxiety was high among this sample of pregnant women. The study shows that dental care providers need to pay attention to providing a supportive dental care situation, where patients should not experience pain. There is a need to understand the psychological factors associated with dental care procedures. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy (...) underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

BackgroundCritical to conducting high quality research is the ability to attract and retain participants, especially for longitudinal studies. Understanding participant experiences and motivators or barriers to participating in clinical research is crucial. There are limited data on healthy participant experiences in longitudinal research, particularly in low- and middle-income countries. This study aims to investigate quantitatively participant experiences in a South African birth cohort study.MethodsMaternal participant experience was evaluated by a self-administered survey in the Drakenstein Child Health Study, a longitudinal birth (...) cohort study investigating the early life determinants of child health. Pregnant mothers, enrolled during the second trimester, were followed through childbirth and the early childhood years. Satisfaction scores were derived from the participant experience survey and quantitatively analyzed; associations between satisfaction scores and sociodemographic variables were then investigated using a linear regression model.ResultsData were included from 585 pregnant mothers, who had participated in the study for a median time of 16 months. Overall participant satisfaction was high and associated with increased attendance of study visits. Reasons for participating were a belief that involvement would improve their health, their child’s health or the health of family and friends. Potential reasons for leaving the study were inconvenience, not receiving clinical or study results, and unexpected changes in study visits or procedures. Variables associated with higher overall satisfaction scores were no prior participation in research, higher socioeconomic status, less intensive follow-up schedules and having experienced stressful life events in the past year.ConclusionsSatisfaction scores were high and associated with increased visit attendance. Participants’ perceived benefits of study participation, most notably the potential for an improvement in the health of their child, were a significant motivator to enroll and remain in the study. The consistent theme of perceived health benefits as a motivator to join and remain in the study raises the question of whether participation in research results in actual improvements in health. (shrink)

Robinson argues that by certain threshold criteria, pregnant women qualify for a higher moral status by reason of their pregnancies. While her intention is to make this a status upgrade for women, we worry that it may result in a status downgrade for women as a class, by presupposing and reinforcing women’s value in relation to their reproductive labour. Historically, central to feminist analysis is resistance to reductive accounts of women in relation to their (...) reproductivity. For example, de Beauvoir addressed men’s transcendence and contrasted it with women’s immanence, a status distinction possible because women are mired in expectations that they will marry, produce children and remain in the domestic realm; and for her part, Firestone argued that biological reproduction underlies women’s inferiority to men and that ‘The reproduction of the species by one sex for the benefit of both (should) be replaced by…artificial reproduction’1 2 Her concern was to liberate women from expectations of biological reproduction so their productive value in society is not reduced to their reproductive contributions. A formidable body of analysis in this same vein cautions against collapsing the value of women into their pregnancies, so much so that some commentators even distinguish ‘mothering’ from gestation.3 Robinson’s argument that pregnant women qualify at a higher threshold of personhood emphasises …. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such (...) as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (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)

Maternal–fetal surgery (MFS) encompasses a range of innovative procedures aiming to treat fetal illnesses and anomalies during pregnancy. Their development and gradual introduction into healthcare raise important ethical issues concerning respect for pregnant women’s bodily integrity and autonomy. This paper asks what kind of ethical framework should be employed to best regulate the practice of MFS without eroding the hard-won rights of pregnant women. I examine some existing models conceptualising the relationship between a pregnant woman (...) and the fetus to determine what kind of framework is the most adequate for MFS, and conclude that an ecosystem or maternal–fetal dyad model is best suited for upholding women’s autonomy. However, I suggest that an appropriate framework needs to incorporate some notion of fetal patienthood, albeit a very limited one, in order to be consistent with the views of healthcare providers and their pregnant patients. I argue that such an ethical framework is both theoretically sound and fundamentally respectful of women’s autonomy, and is thus best suited to protect women from coercion or undue paternalism when deciding whether to undergo MFS. (shrink)