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

Autor: Bernabe Rosemarie D L C, van Thiel Ghislaine J M W, Raaijmakers Jan A M, van Delden Johannes J M
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: BMC Medical Ethics, Vol 13, Iss 1, p 6 (2012)
Druh dokumentu: article
ISSN: 1472-6939
DOI: 10.1186/1472-6939-13-6
Popis: 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.
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