How research ethics boards should monitor clinical research

Account Res. 2020 Jan;27(1):49-56. doi: 10.1080/08989621.2019.1706048. Epub 2019 Dec 17.

Abstract

The objective of this commentary is to provide a framework and ethical justification for a more proactive model of continual, active monitoring of research. We outline what the increased monitoring should consist of, and the practical constraints associated with executing these monitoring functions. We also defend the idea that adequate post-initial-review monitoring requires greater REB involvement, rather than trust and researcher's assurances.

Keywords: Continual monitoring; Research Ethics Boards/Institutional Review Boards; clinical research; subject safety and research integrity.

MeSH terms

  • Clinical Audit / organization & administration*
  • Clinical Audit / standards
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / organization & administration*
  • Clinical Trials as Topic / standards
  • Ethics Committees, Research / organization & administration*
  • Ethics Committees, Research / standards
  • Humans