Ethics of Conducting Clinical Research in an Outbreak Setting

Annu Rev Virol. 2020 Sep 29;7(1):475-494. doi: 10.1146/annurev-virology-013120-013123. Epub 2020 Mar 25.

Abstract

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.

Keywords: Ebola; clinical research; coronavirus; epidemic; ethics; outbreak; pregnant women.

Publication types

  • Review

MeSH terms

  • Adult
  • Africa, Western / epidemiology
  • Antiviral Agents / therapeutic use
  • Biomedical Research / ethics*
  • Biomedical Research / organization & administration
  • Child
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / organization & administration
  • Disease Outbreaks*
  • Ebola Vaccines / administration & dosage
  • Ebolavirus / pathogenicity*
  • Female
  • Hemorrhagic Fever, Ebola / epidemiology*
  • Hemorrhagic Fever, Ebola / immunology
  • Hemorrhagic Fever, Ebola / mortality
  • Hemorrhagic Fever, Ebola / prevention & control
  • Humans
  • International Cooperation
  • Male
  • Patient Selection / ethics*
  • Pregnancy
  • Survival Analysis

Substances

  • Antiviral Agents
  • Ebola Vaccines