title: Decision theory and the evaluation of risks and benefits of clinical trials.
abstract: Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making.
authors: Utrecht University Medical Center, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands. r.bernabe@umcutrecht.nl
authors: Rosemarie D C
authors: RD
authors: Bernabe
authors: Ghislaine J M W
authors: GJ
authors: van Thiel
authors: Jan A M
authors: JA
authors: Raaijmakers
authors: Johannes J M
authors: JJ
authors: van Delden
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D003657:Decision Making; D003661:Decision Support Techniques; D003662:Decision Theory; D028744:Ethics Committees, Research; D025341:Principal Component Analysis; D018570:Risk Assessment