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The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate
Rosemarie D L C Bernabe1, Ghislaine J M W van Thiel, Jan A M Raaijmakers
1Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht, 3584CX, the Netherlands. R.Bernabe@umcutrecht.nl
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.
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