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 … Read more

In contrast to many areas of health research, the field of HIV/AIDS has pursued research with pregnant women as a key component of its research agenda. Several large trials have made vivid a number of critical ethical questions for research with pregnant women broadly–including how risks and benefits can and should be traded off between … Read more

To the Editor We read with great interest the article “Association of Acetaminophen Use During Pregnancy With Behavioral Problems in Childhood: Evidence Against Confounding.” While we applaud and support efforts to responsibly advance the evidence base regarding medication use in pregnancy, we were deeply concerned by the description and communication of the study findings.

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 … Read more

For parents, the experience of having an infant in the NICU is often psychologically traumatic. No parent can be fully prepared for the extreme stress and range of emotions of caring for a critically ill newborn. As health care providers familiar with the NICU, we thought that we understood the impact of the NICU on … Read more

The rapid spread of the Zika virus — and its now clear association with microcephaly in babies exposed prenatally — has put extraordinary pressure on the research community to develop a vaccine as rapidly as possible. But accelerating the development of this vaccine is not only scientifically and logistically complicated, it is ethically complicated.

Much of the debate on conscience has addressed the ethics of refusal: the rights of providers to refuse to perform procedures to which they object and the interests of the patients who might be harmed by their refusals. But conscience can also be a positive force, grounding decision about offering care.

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum … Read more

BACKGROUND: Laws governing abortion provision are proliferating throughout the United States, yet little is known about how these laws affect providers. We investigated the experiences of abortion providers in North Carolina practicing under the 2011 Women’s Right to Know Act, which mandates that women receive counseling with specific, state-prescribed information at least 24 hours prior … Read more

Disclosing harmful medical errors to patients is a prominent component of the patient safety movement. Patients expect it and safety agencies and experts advocate its implementation. Obstetrics presents unique challenges to carrying out disclosure recommendations: childbirth is a life-changing, emotionally charged, and dynamic family event characterized by high expectations and unpredictability, and perinatal care is … Read more