Group to develop guidelines for inclusion of pregnant women in public health research

The emerging Zika virus epidemic has brought to light a longstanding ethical challenge in medical research: the inclusion of pregnant women.

Image caption: Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics

With new funding from the Wellcome Trust, an interdisciplinary team of scholars—including Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics—will focus on issues of research on pregnant women and women of reproductive age. The group will focus initially on the current Zika outbreak and later expand to general public health research.

"The Zika epidemic is highlighting a long-time problem in medical research—the exclusion of the interests of pregnant women from the research agenda," said Faden, co-principal investigator on the research team. "While the legal and ethical issues involved in testing new vaccines and drugs in this population are complex, that is not a justification for failing to generate evidence that is badly needed to meet the distinctive health needs of pregnant women, who are often at heightened risk during a public health crisis."

Faden's co-principal investigator is obstetrician-bioethicist Anne Lyerly, associate director of the University of North Carolina Center for Bioethics. Joining them are bioethics colleagues with training in law, philosophy, public health, and religious ethics, as well as a team of advisors from Central and South America and experts in vaccinology and infectious diseases, maternal-fetal medicine, and public health emergency response. With a £1.2 million (approximately $1.7 million) grant from the Wellcome Trust, the group will spend two years developing guidance for conducting research with pregnant women in the midst of a public health crisis.

The scholars plan to conduct 50 consultations in Zika-affected countries and in the United States, and will convene a series of expert working groups to help develop and refine guidance for addressing the health interests of pregnant women in Zika and other public health emergency research agendas.

"Pregnant women's bodies are different and often respond differently to medication and vaccines," Lyerly said. "Further, the fetus is susceptible to risk from medication or untreated disease. Knowing which preventives and treatments are safest and most effective in pregnancy requires conducting research with pregnant women. Not doing that research just shifts risk to the general population—where pregnant women take on unknown risks for themselves and the children they bear. That is hardly an ethical state of affairs."

For Faden, the group's goals are personal, as well as ethical.

"When I was pregnant with my first child, I developed deep vein thrombosis and had to have regular drug injections as treatment," she said. "My physicians had little evidence to support their decision, which was very scary. That was decades ago and unfortunately little has changed. I want other parents-to-be to have more peace of mind than I did."

The co-investigators for the study are: Margaret Little, director of the Kennedy Institute of Ethics at Georgetown University; Anna Mastroianni, from the University of Washington School of Law; and Leslie Meltzer Henry, from the Johns Hopkins Berman Institute of Bioethics and the University of Maryland Francis King Carey School of Law.