IMPRINT board member Sonali Kochhar, Medical Director at Global Healthcare Consulting and Clinical Associate Professor at the Department of Global Health, University of Washington, co-authored a paper on the "Ethics of Conducting Clinical Research in an Outbreak Setting" in the Annual Review of Virology. The article includes ethical considerations for the inclusion of pregnant women in therapeutic and vaccine trials during current outbreaks. It will be published in September 2020, and a pre-published version can be downloaded below.
The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with future outbreaks were the subject of a National Academy of Medicine committee report titled Integrating Clinical Research into Epidemic Response: The Ebola Experience. This report suggested improvements for research during subsequent emerging or re-emerging outbreaks and is summarized in this review. We also discuss the current Ebola outbreak in the Democratic Republic of the Congo and highlight how the dialogue has changed and how successful clinical trials have been implemented. We conclude with a description of productive efforts to include pregnant women and children in therapeutic and vaccine trials during outbreaks that are currently ongoing.
Kathryn M. Edwards & Sonali Kochhar, Annual Review of Virology 2020, 7
The IMPRINT network has developed a survey for monitoring how immunisation efforts for pregnant women, newborns and infants are impacted by the COVID-19 pandemic.