Women's views about contraception requirements for biomedical research participation.

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored.

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response.

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks.

Beyond "Vessels and Vectors": A Global Review of Registered HIV-Related Clinical Trials with Pregnant Women.

Background: Since the early 1990s, the HIV research agenda has prioritized to some degree the inclusion of pregnant women. However, concerns remain regarding the extent to which pregnant women's own health needs are addressed, representation in trials of HIV preventives or treatments for comorbidities, and equitable study of newer medications during pregnancy.

Methods: We employed a keyword search of the International Clinical Trials Registry Platform to identify interventional HIV-related trials conducted with pregnant women between January 2001 and December 2015.

Research with pregnant women: a call to action.

Despite a global need for the use of medication during pregnancy, the medical research community lacks robust evidence for safety and efficacy of treatments and preventives often taken by pregnant women. Given the biological differences between pregnant women and the rest of the population, the need to gather data on the ways in which medications behave in the pregnant body is critical to the health of pregnant women and their offspring. Three ethical reasons are central to this need: 1.

Research with Pregnant Women: New Insights on Legal Decision-Making.

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.

Advancing HIV research with pregnant women: navigating challenges and opportunities.

Objective: Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research.

Methods: We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women.

Toward an ethically responsible approach to vaginal birth after cesarean.

Determining approach to delivery after a previous cesarean is among the most contentious areas of obstetrics. We present a framework for ethically responsible guidelines and practice regarding vaginal birth after cesarean. We describe ethical complexities of 3 key issues that mark the debate: the cesarean delivery rate, safety, and patient autonomy.

Risk and the pregnant body.

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

The second wave: Toward responsible inclusion of pregnant women in research.

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.

The National Children's Study: a golden opportunity to advance the health of pregnant women.

With a $3 billion investment by the federal government, the National Children's Study (NCS) recently began recruitment. The NCS is a golden-and potentially missed-opportunity to study one of the most underrepresented populations in clinical research: pregnant women. As the nation's largest-ever study of children's health, the NCS will examine the effects of the environment on children from before birth to 21 years of age, with participants sampled primarily through women during pregnancy.

Mode of delivery: toward responsible inclusion of patient preferences.

Deciding when and how to incorporate patient preferences regarding mode of delivery is challenging for both obstetric providers and policymakers. An analysis of current guidelines in four clinical scenarios (prior cesarean, twin delivery, breech presentation, and maternal request for cesarean) indicates that some guidelines are highly prescriptive whereas others are more flexible, based on physicians' discretion or (less frequently) patient preferences, without consistency or explicit rationale for when such flexibility is permissible, advisable, or obligatory. Although patient-choice advocates have called for more patient-responsive guidelines, concerns also have been raised, especially in the context of discussions of cesarean delivery on maternal request, about the dangers of unfettered patient-preference-driven clinical decisions.

Risks, values, and decision making surrounding pregnancy.

Assessing, communicating, and managing risk are among the most challenging tasks in the practice of medicine and are particularly difficult in the context of pregnancy. We analyze common scenarios in medical decision making around pregnancy, from reproductive health policy and clinical care to research protections. We describe three tendencies in these scenarios: 1) to consider the probabilities of undesirable outcomes alone, in isolation from women's values and social contexts, as determinative of individual clinical decisions and health policy; 2) to regard any risk to the fetus, including incremental risks that would in other contexts be regarded as acceptable, as trumping considerations that may be substantially more important to the wellbeing of the pregnant woman; and 3) to focus on the risks associated with undertaking medical interventions during pregnancy to the exclusion of demonstrable risks to both woman and fetus of failing to intervene.

Dana-Farber Cancer Institute ethics rounds: life-threatening illness and the desire to adopt.

Originally presented during Ethics Rounds at the Dana-Farber Cancer Institute, this commentary on the case of a patient treated for life-threatening cancer explores the responsibilities of health care providers when addressing the patient's desire to adopt a child.

Procreative liberty, biological connections, and motherhood.

Given the complex and dramatic array of issues currently facing us in reproductive ethics, bioethicists working on the topic might be forgiven feelings of trepidation when they cast their minds toward the next century. Currently, technologies such as artificial insemination by donor (AID), once the source of intense controversy, are used on a routine basis; mainstream newspapers carry advertisements offering "excellent compensation" to ova "donors;" courts are arguing whether women who serve as gestational or "surrogate" mothers have any parental rights; and proposals resurface to jail pregnant women who take street drugs. Sorting out which developments are to be welcomed and which are to be resisted -- and why -- will require us not only to clarify some of our most basic value commitments, but also to reflect on our understanding of concepts, such as motherhood, that we previously had the luxury of thinking obvious.