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The emerging Zika virus epidemic is bringing to light a longstanding ethical challenge in medical research: the inclusion of pregnant women. With new funding from the , an interdisciplinary team of scholars including Anna Mastroianni, University of �鶹���� of Law professor, will examine legal and ethical issues of research in pregnancy and women of reproductive age, beginning with the current Zika context and later expanding to general public health research.

“Our work will contribute to the efforts of our medical, scientific and policymaking colleagues to ensure that ethical and legal considerations inform the all-out global research efforts to improve the health of pregnant women and their future children during the Zika crisis and beyond,” says Mastroianni, a co-investigator on the research team, who noted that pregnant women have traditionally been excluded from clinical research.

“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,” says Ruth Faden, Director of the Johns Hopkins Berman Institute of Bioethics and co-principal investigator.

Working with Mastroianni and Faden is co-principal investigator, obstetrician-bioethicist Anne Lyerly, Associate Director of the University of North Carolina Center for Bioethics, and bioethics colleagues with training in law, philosophy, public health, and religious ethics. The co-investigators are: Margaret Little, Director of the Kennedy Institute of Ethics at Georgetown University; and Leslie Meltzer Henry, Johns Hopkins Berman Institute of Bioethics and the University of Maryland Francis King Carey School of Law. 

With a £1.2 million grant from the Wellcome Trust, the scholars will spend two years developing guidance for conducting research with pregnant women in the midst of a public health crisis.

The research team will also include advisors from Central and South America as well as experts in vaccinology and infectious disease, maternal-fetal medicine, and public health emergency response. The scholars plan to conduct 50 consultations in Zika-affected countries and in the United States, and 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.

Several members of the research team have worked for more than a decade on these issues; in 2008 Faden, Lyerly, and Little launched the Second Wave Initiative, referencing the “first wave” of efforts of the early 1990s to include women in the biomedical research agenda.  In the 1990s, Mastroianni and Faden led efforts to examine ethical and legal issues surrounding women’s participation in clinical research. Mastroianni says that the successes of the last two decades in that area have now shifted to confronting the ethical challenges of ensuring that the health of pregnant women can benefit from research as well.

“There are numerous ethical and legal challenges working with pregnant women in the research context. At the core, though, it’s a justice issue,” says Mastroianni. “We owe it to all women and their families to ensure that pregnant women and their children derive the health benefits that come from ethically conducted research.”

Mastroianni will participate in the development of ethics guidance, examining the complex U.S. and international legal context for conducting research with pregnant women, including challenges raised by the regulatory system, reproductive rights, and the potential for long-tail liability.

“What’s particularly interesting from a legal perspective is how research is affected by a public health emergency,” says Mastroianni. “On top of all the other laws we’re looking at, we also have to layer on the legal variability arising when clinical trials are conducted in global public health emergencies like Zika.”

Dan O’Connor, Head of Humanities and Social Science at the Wellcome Trust, adds, “The suspected link to serious birth defects has shown that pregnant women are particularly vulnerable to the complications of Zika virus. Yet this group is often the last to benefit from new treatments and vaccines because they are excluded from most medical trials. We urgently need a new set of ethical guidelines to ensure pregnant women are included in, and able to benefit from, medical research wherever possible in a public health emergency.”