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While pregnant people are among those most in need of access to effective treatment and preventive drugs and vaccines, evidence to inform use of pharmaceuticals in pregnancy is sorely lacking. Recent years have seen growing recognition of the urgent need to increase responsible research in pregnancy. This chapter outlines the state of play on key issues regarding such research. First, it describes evidence gaps, their systemic causes, and their human and moral costs. Next, it addresses conditions under which pregnant people may ethically be included in studies, highlighting issues of allowable risk, consent, and abortion. Finally, it turns to the important issue of fair inclusion of pregnant participants in research, at the levels of both agenda-setting structures and individual trials. Together these considerations point to the collective responsibility of the global research community to identify and pursue research that meets the needs and honors the interests of pregnant people.

Despite progress in representing various populations in clinical research, one group has been left behind: pregnant women. Though millions of pregnant women annually need to use medication, whether to treat chronic illness or prevent infectious disease, pregnant women have been systematically excluded from the social investment in clinical research required to generate evidence to inform their care. This chapter articulates three models that have been advanced for morally framing research with pregnant women: an unfettered protectionist model, in which pregnant women are categorized as a “vulnerable population” for purposes of clinical research; a model of unrestricted deference to the pregnant woman’s autonomy; and a model that construes the fetus as a pediatric research subject. Each, it is argued, is critically flawed. With lessons learned from their respective limitations, the chapter points toward ways in which research during pregnancy must be given unique consideration, and toward development of an adequate framework.

Advancing fair access to evidence-based pregnancy-related services is a critical public health priority. It is widely recognized that there are inequalities in lifesaving interventions. This chapter however addresses issues raised by services whose value or utility are contested. Using illustrative examples of prenatal genetic testing and modes of childbirth, the chapter highlights the ways in which issues of access are complicated by social and cultural ideas about what is valued; discusses contested questions about what is ethically responsible or required of patients, providers, and public health systems in these reproductive health contexts; and addresses areas of needed research and further ethical analysis. It concludes that issues of access in pregnancy-related care must attend both to broad issues of justice and access and to particular ways that pregnancy services are valued, debated, and made available to women who might—or might not—benefit from them.

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