Email updates

Keep up to date with the latest news and content from BMC Medical Ethics and BioMed Central.

Open Access Debate

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

Rosemarie D L C Bernabe1*, Ghislaine J M W van Thiel1, Jan A M Raaijmakers2 and Johannes J M van Delden1

Author affiliations

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

For all author emails, please log on.

Citation and License

BMC Medical Ethics 2012, 13:6  doi:10.1186/1472-6939-13-6

Published: 20 April 2012

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.

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