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Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

July 12, 2018

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 … Read more

Navigating Ethics Review of Human Infection Trials With Zika

May 3, 2018

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 … Read more

Bystander risk, social value, and ethics of human research

April 17, 2018

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 … Read more

Harm Reduction Protocols for Early Abortion: A Middle Way?

April 13, 2018

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 … Read more

Of Pain and Childbirth

December 19, 2017

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. … Read more

Ethics, Pregnancy, and ZIKV Vaccine Research and Development

October 23, 2017

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 … Read more

Rubella and Zika Vaccine Research-A Cautionary Tale About Caution

June 26, 2017

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 … Read more

Prenatal Exome Sequencing in Anomalous Fetuses

May 18, 2017

PurposeWe investigated the diagnostic and clinical performance of exome sequencing in fetuses with sonographic abnormalities with normal karyotype and microarray and, in some cases, normal gene-specific sequencing.MethodsExome sequencing was performed on DNA from 15 anomalous fetuses and from the peripheral blood of their parents. Parents provided consent to be informed of diagnostic results in the … Read more