Regulating impact on bystanders in clinical trials: An unsettled frontier

Clin Trials. 2019 Oct;16(5):450-454. doi: 10.1177/1740774519862783. Epub 2019 Aug 1.


This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.

Keywords: Research ethics; bystander; clinical ethics; clinical trials; human research subject protection; research nonparticipant; third party consent.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials as Topic*
  • Ethics, Research*
  • Guidelines as Topic*
  • Humans
  • Informed Consent / ethics
  • Risk
  • Therapeutic Human Experimentation / ethics*
  • Therapeutic Human Experimentation / legislation & jurisprudence