Social value, clinical equipoise, and research in a public health emergency

Bioethics. 2019 Mar;33(3):326-334. doi: 10.1111/bioe.12467. Epub 2018 Jul 27.


The 2016 CIOMS International ethical guidelines for health-related research involving humans states that 'health-related research should form an integral part of disaster response' and that, 'widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided' (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high-mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage.

Keywords: CIOMS guidelines; Ebola; equipoise; public health emergencies; research ethics; right to try.

MeSH terms

  • Biomedical Research / ethics*
  • Critical Illness / mortality
  • Critical Illness / therapy
  • Disasters*
  • Disease Outbreaks / ethics*
  • Dissent and Disputes
  • Emergencies
  • Ethics, Medical
  • Ethics, Research
  • Evidence-Based Medicine
  • Guidelines as Topic*
  • Hemorrhagic Fever, Ebola / epidemiology
  • Hemorrhagic Fever, Ebola / therapy*
  • Human Experimentation / ethics*
  • Human Rights
  • Humans
  • International Cooperation*
  • Moral Status
  • Organizations
  • Public Health Practice / ethics
  • Research Design
  • Social Values
  • Standard of Care