Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation (2017)
The Ethics Working Group on ZIKV Research & Pregnancy, “Pregnant Women & The Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation,” (June 2017)
URL: guidance.zikapregnancyethics.org/
Abstract
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), is a result of infection during pregnancy. As a consequence, pregnant women figure prominently in global concerns about ZIKV. They should also figure prominently in ZIKV vaccine development, but the way forward is not well established. Significant questions remain about what specifically is required to ensure that these interests are adequately protected and fairly taken into account in ZIKV vaccine research. Guidance is also needed on the conditions under which is it ethically acceptable, if not required, to include pregnant women in ZIKV vaccine trials.
This document will significantly impact the ethical framework of research and practices influencing the health of women and their children affected by the Zika virus. It also demonstrates a growing trend in research ethics that advocates for the inclusion of pregnant women in research trials under certain circumstances. This is important in light of long-standing protections for pregnant women as a vulnerable population in human subject research.
