Ethical Considerations for Zika Virus Human Challenge Trials image

National Institute of Allergy and Infectious Diseases (NIAID) at NIH and the Walter Reed Army Institute of Research (WRAIR), February 2017
Seema K. Shah, Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch (Executive Director), et al.


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From the report:

Zika virus is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. Zika virus has recently been shown to cause devastating neurological damage in infants and serious complications in adults in some cases, and may have other effects that have not yet been identified or definitively linked to the virus. There are no treatments or vaccines for this insidious virus. While important, current measures for mosquito control are insufficient in most settings to prevent the spread of the virus. Recommendations that women who live in or travel to endemic areas avoid pregnancy for long periods of time are unrealistic, particularly in contexts where access to reproductive services is limited, and threaten to leave those most likely to suffer the devastating consequences of Zika without effective protection. There is therefore urgent need to develop biomedical interventions in parallel with ongoing public health efforts against Zika virus. While interventions are being developed and tested, a large number of infants will likely be born with intrauterine exposure to a virus with increased risks of adverse outcomes in regions of the world where the epidemic is ongoing. One powerful tool for developing treatments and vaccines for infectious diseases is human challenge research, in which volunteers are purposefully exposed to pathogens in order to answer research questions with enhanced rigor and efficiency. 

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bioethics health law policy holly fernandez lynch public health regulation