Conducting Ethical Research With Pregnant Women in the Emerging Zika Pandemic and Beyond: Challenges Arising in Public Health Crises

The central research question of the proposed project is how, in the context of the Zika crisis, to address the myriad ethical challenges that arise in the conduct of research when there is an urgent need to attend to the health needs of pregnant women and their offspring. An essential and integrated sub- question is to examine these same challenges in the context of public health emergencies more generally, to avoid repeating mistakes from the past and anticipate future public health needs. The core objectives of the project are: 1. To conduct engagement with key experts, and conduct scholarly research in ethics and law, in order to understand the needs, challenges, and opportunities for conducting research on pregnant women and women who may become pregnant 1 in the Zika context, in particular, and public health emergencies, in general; 2. To develop, in conjunction with an international expert advisory group, rapid and ongoing concrete ethical guidance for conducting research involving pregnant women in the Zika context, and a framework for approaching public health emergencies requiring research in pregnant women. Using the methods described below, Year 1 will emphasize the most immediate and time-sensitive issues for advancing Zika research for pregnant women. Year 2 will provide ongoing analysis and guidance as the Zika crisis evolves and research findings emerge, and will further develop analysis and guidance on research involving pregnant women in public health emergencies more broadly, including research specific to other potential infectious disease outbreaks and to environmental and bioweapons threats.