As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women’s willingness to participate in Zika virus … Continued

Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth … Continued

Human infection challenge studies, which deliberately expose healthy volunteers to disease-causing infectious agents under carefully controlled conditions, offer a valuable method of biomedical research aimed at efficient initial efficacy testing of vaccine candidates, among other possible uses. They can be controversial, however, often evoking the response, “How can researchers do that?” Although Nazi physicians conducted … Continued

Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated when risks are substantial but not offset by direct benefit to participants, and the benefit … Continued

Excerpt One late evening in the 1990s when I (Dr. Lyerly) was a resident, our gynecology team was called to evaluate a young woman in shock. According to her husband, she had not been herself for a couple of days, then she fainted on the kitchen floor, her pants soaked in blood. That was all … Continued

Childbirth is often understood as a paradigmatically “happy” event where good outcomes are expected and the process anticipated as a reason for celebration. Yet the narratives in this volume reflect sadness and grief, even when a healthy child is born. In this essay, I interrogate the genesis of and our relationship to grief in birth. … Continued

Though many women in need of access to HIV preventive regimes are pregnant, there is a dearth of data to guide these care decisions. While oral pre-exposure prophylaxis (PrEP) has been shown to prevent HIV infection in numerous high-risk populations, pregnant women have been excluded from all major prospective trials. We propose for ethical examination … Continued

The US Centers for Disease Control and Prevention (CDC) recently released updated interim guidance for when pregnant women should receive serologic testing for the Zika virus. The circumstances within which these recommendations emerge are complex: the public concern about the Zika virus is declining, the severity of epidemics around the globe is abating, and as … Continued

The rapid spread of the Zika virus (ZIKV) has galvanized the global public health community toward development of ZIKV vaccines. The most dire consequence of ZIKV infection, Congenital ZIKV Syndrome (CZS), results from infection during pregnancy. As a consequence, pregnant women figure prominently in global concerns about ZIKV. They should also figure prominently in ZIKV … Continued

The public health response to the Zika crisis has evoked debate and critique, although there has been at least 1 clear success: rapid progress toward a vaccine, with phase 2 testing starting in early 2017, just a year after the Public Health Emergency of International Concern was declared. Among the challenges of developing a vaccine … Continued