The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods
1 Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht, 3584CX, the Netherlands
2 GlaxoSmithKline, Huis ter Heideweg 62, Zeist, 3705 LZ, the Netherlands
BMC Medical Ethics 2012, 13:6 doi:10.1186/1472-6939-13-6Published: 20 April 2012
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.
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.
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.