title: The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods.
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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht, 3584CX, the Netherlands. R.Bernabe@umcutrecht.nl
authors.forename: Rosemarie D L C
authors.initials: RD
authors.lastname: Bernabe
authors.forename: Ghislaine J M W
authors.initials: GJ
authors.lastname: van Thiel
authors.forename: Jan A M
authors.initials: JA
authors.lastname: Raaijmakers
authors.forename: Johannes J M
authors.initials: JJ
authors.lastname: van Delden
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D003142:Communication; D003657:Decision Making / Q000941:ethics; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D012107:Research Design; D018570:Risk Assessment