A multi-year project funded by the U.K.'s Wellcome Trust.
Led by investigators at several major U.S. universities, our interdisciplinary team of scholars seeks ethical solutions to ensure that the health needs of pregnant women and their offspring are appropriately included in research efforts addressing emerging public health crises.
The emerging public health crisis around Zika infection has highlighted the need for concrete guidance to navigate the complex ethical questions around whether, when, and how to extend research to pregnant women. Over the past year, the Zika virus has spread explosively throughout Latin America and the Caribbean, with endemic cases continuing in 58 countries and an estimated 4 million cases expected in 2016 across the Western Hemisphere. The rapid spread of the virus and its devastating impacts on the normal brain development of babies exposed prenatally has led the WHO to declare Zika a Public Health Emergency of International Concern.
In this context, the research and public health communities urgently need concrete, actionable guidance to navigate the complex ethical questions around whether, when, and how to extend research on biomedical interventions, including prevention, diagnostic and treatment modalities, to pregnant women.
There is a dearth of evidence to guide treatment, diagnosis, and prevention, stemming from questions and confusions about the ethical and legal permissibility of including pregnant women in research. It is widely known that pregnancy can alter metabolism of drugs and response to vaccines; further, medications and biologics can entail fetal risk. However, antivirals and vaccines used during pregnancy have the potential to prevent the myriad congenital problems associated with Zika infection. Additionally, any vaccination campaign targeting women of reproductive age is likely to include women who are pregnant. These facts underscore the need for a reasoned discussion of the ethical issues and potential approaches to ensuring that the health interests of pregnant women and their offspring are included responsibly in responses to the Zika crisis and future public health emergencies.
This project aims to develop concrete, actionable, consensus-driven guidance for conducting ethically responsible biomedical research with pregnant women in the context of public health emergencies – with an initial focus on Zika vaccine research. Our approach is multi-disciplinary, bringing together a team of scholars in law, philosophy, public health, bioethics, obstetrics, and history of medicine, alongside a team of advisors from the U.S. and Latin America who specialize in maternal-fetal medicine, vaccine research, and maternal immunization.
This guidance will be informed by scholarly research and extensive consultation with experts, ensuring that it will be: (1) responsive to the planned research and development activities; (2) informed by the best available scientific and medical evidence; and (3) relevant to the real-world public health response in and social and cultural contexts of areas hit hardest by the epidemic.
Challenges around pregnancy and research for public health emergencies are not limited to Zika. Furthermore, pregnant women often face heightened risk in the context of emerging public health crises. In the second year of our project, we will expand our focus beyond Zika to develop a more generalizable framework for the responsible and ethical inclusion of pregnant women in research responding to a variety of outbreaks and public health emergencies. This will help ensure that the health needs of pregnant women and their future offspring are equitably represented in biomedical research in the face of emerging health crises.