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

• Published in: BMC medical ethics Vol. 13; no. 1; p. 6
• Main Authors: Bernabe, Rosemarie D L C, van Thiel, Ghislaine J M W, Raaijmakers, Jan A M, van Delden, Johannes J M
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20.04.2012; BioMed Central; BMC
• Subjects: Clinical trials; Clinical Trials as Topic - ethics; Committees; Communication; Component analysis; Debate; Decision making; Decision Making - ethics; Decision theory; Ethics committee; Ethics Committees, Research; Ethics, Research; Health sciences; Humans; Intervention; IRB; Methods; Net risk test; Research Design; Research ethics; Risk Assessment; Risk benefit assessment; Netherlands
• ISSN: 1472-6939; 1472-6939
• DOI: 10.1186/1472-6939-13-6

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.