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

BMC Medical Ethics

Johannes J M van Delden¹  JanA M Raaijmakers²  Ghislaine J M W van Thiel¹  Rosemarie D L C Bernabe¹ 

[1] Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht, 3584CX, the Netherlands;GlaxoSmithKline, Huis ter Heideweg 62, Zeist, 3705 LZ, the Netherlands

关键词: Component analysis;    Net risk test;    Decision theory;    IRB;    Ethics committee;    Risk benefit assessment;   

Others  :  800051
DOI  :  10.1186/1472-6939-13-6

 received in 2012-04-05, accepted in 2012-04-11,  发布年份 2012

【 摘 要 】

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.

【 授权许可】

   
2012 Bernabe et al.; licensee BioMed Central Ltd.

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