Heterogeneous perception of the ethical legitimacy of unbalanced randomization by institutional review board members: a clinical vignette-based survey.

ABSTRACT:

Background

Institutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted. However, some may regard an unbalanced randomization ratio as reflecting an absence of uncertainty between the groups being compared. The objective was to assess institutional review board members' perceptions of whether unbalanced randomization in randomized controlled trials is justified and ethically acceptable.

Methods

Institutional review board members worldwide completed a survey involving clinical vignettes modeling situations classically advocated to explain the use of unbalanced randomization. Institutional review board members were asked whether unbalanced randomization was justified and ethically sound. Answers were collected by

SUBMITTER: Dibao-Dina C 

PROVIDER: S-EPMC6092831 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature