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)

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)

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)

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)

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: that it stems from the unthinking exportation of (...) prison rules to a hospital setting and 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)

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)

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)

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)

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

This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift (...) to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant (...) class='Hi'>women. Analysis A conceptual analysis supports Hurst's definition of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (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)

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)

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)

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)

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)

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)

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)

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 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)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence (...) of the increased numbers of women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence (...) of the increased numbers of women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (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)

Recourse to a being’s moral status is the ‘nuclear option’ of moral theorising—it tells us not only what obligations we have and to what degree, but whether we have obligations to them in the first place and whether their moral concern trumps concern for other beings simply in virtue of the kind of being they are. As such, we should only explain obligations in terms of a being’s moral status if doing so is principled and necessary to defend that obligation. (...) In ‘Pregnancy and Superior Moral Status: A Proposal for Two Thresholds of Personhood’, Robinson1 argues that pregnant women achieve a second and therefore superior threshold of moral status to ‘mere persons’. She insists that this is not a view about the woman and the fetus together but that ‘the pregnant woman herself is more than one individual’. This gives us strong reason to re-balance the imbalanced burdens experienced by women due to pregnancy. I will argue her proposal is neither principled nor necessary. We can explain special obligations to pregnant women without appealing to a distinct moral status, without reaching for the ‘nuclear option’. First, consider Robinson’s1 claim that pregnant women ‘are performing a role which is of supreme importance: that of creating new human life, and maintaining the survival of the human species’. …. (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)

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women’s responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The (...) minority of the participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care. (shrink)

As a feminist bioethicist, I have frequently wondered why the exclusion of pregnant women has been the default position for most clinical research and how social values have influenced this decision. Relatedly, I wonder what responsible research involving pregnant women would look like. As a theorist who conducts research on the concept of vulnerability, I have often wanted to know why there has been so little research into the harmful effects of the routine exclusion of (...) class='Hi'>pregnant women, including questions such as: What do pregnant women actually think about participating in research? How should we treat pregnant women and their fetuses for the purposes of consent (are they two separable persons or one complex... (shrink)

There 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. We 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. Three 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. Healthcare 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)

Background Noninvasive prenatal testing (NIPT) provides important benefits yet raises ethical concerns. We surveyed Canadian pregnant women and their partners to explore their views regarding pressure to test and terminate a pregnancy, as well as other societal impacts that may result from the routinization of NIPT.Methods A questionnaire was offered (March 2015 to July 2016) to pregnant women and their partners at five healthcare facilities in four Canadian provinces.Results 882 pregnant women and 395 partners (...) completed the survey. 64% of women anticipated feeling no pressure to take the test if it were offered routinely, and 39% were not concerned about routinization leading to increased pressure to terminate a pregnancy of a fetus with Down Syndrome. Regarding other social concerns possibly resulting from routinization, pregnant women were most concerned regarding a reduction in resources available for people with Down Syndrome and their families and least concerned regarding a decrease in the population of people with Down Syndrome.Conclusions Our findings reflect the concerns expressed by pregnant women and their partners, both personal (pressure to test, pressure to terminate) and societal (e.g., regarding potential negative impact on people with disabilities and their families). Even if most women were not concerned about feeling pressured to test due to NIPT routinization, a large minority express concerns that should not be taken lightly. Moreover, a majority of respondents were concerned regarding pressure to terminate pregnancies due to NIPT routinization as well as regarding most societal impacts they were queried on, especially the possible future reduction in resources available for people with DS and their families. Canadian policy-makers should consider these potential negative ramifications of NIPT and ensure that appropriate social policies accompany its implementation. (shrink)

The COVID-19 pandemic has dramatically changed the patterns of lifestyle and posed psychological stress on pregnant women. However, the association of sleep duration and screen time with anxiety among pregnant women under the backdrop of the COVID-19 pandemic scenario has been poorly addressed. We conducted one large-scale, multicenter cross-sectional study which recruited 1794 pregnant women across middle and west China. Self-reported demographic characteristics, lifestyle, and mental health status were collected from 6th February to 8th (...) May 2020. We investigated the association of sleep duration and screen time with the risk of anxiety by multivariable logistic regression analysis and linear regression analysis after adjusting potential confounders. The dose-response relationship of sleep duration and screen time with anxiety was visualized using a cubic spline plot. Our data revealed that almost 35% of pregnant women suffered from anxiety during the COVID-19 pandemic. Sleep duration was dose-dependently associated with a lower risk of anxiety among pregnant women, while screen time exhibited a conversed effect. Notably, sleep duration synergistically combined with screen time to diminish the risk of anxiety. Taken together, sleep duration and screen time were independently and jointly associated with anxiety. Therefore, promoting a more active lifestyle and maintaining higher sleep quality could improve the mental health of pregnant women, especially under public health emergency. (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)

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)

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)

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)

This study appeared in full in the last issue of Research Ethics Review : 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)

: The Centers for Disease Control and Prevention (CDC) has recommended that HIV testing be routinely offered to certain patients in hospitals with a high prevalence of HIV infection and on all pregnant women. The CDC does not, however, offer implementation level guidelines for obtaining informed consent. We provide a moral justification for requiring informed consent for HIV testing and propose guidelines for securing such consent. In particular we argue that genuine informed consent can be secured without elaborate (...) counseling, such as that currently used at Counseling and Testing Sites, provided that sufficient written notice is given to the patients before testing and that they are specifically asked for permission. (shrink)