The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods

BMC Med Ethics. 2012 Apr 20:13:6. doi: 10.1186/1472-6939-13-6.

Abstract

Background: Research ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.

Discussion: By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs' risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.

Conclusion: As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs' risk-benefit task.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic / ethics*
  • Communication
  • Decision Making* / ethics
  • Ethics Committees, Research*
  • Ethics, Research*
  • Humans
  • Research Design*
  • Risk Assessment