Informed consent in critically ill adults participating to a randomized trial.

ABSTRACT:

Objective

The 2014 update of the Swiss law on research increases patients' protection; it adds specific requirements for emergency situations, implying an active search for patients' wishes regarding research participation; the possibility of consent waivers is not clearly stated. We explored its practical impact in a RCT on critically ill adults.

Methods

We considered prospectively collected consents of a multicenter trial addressing the impact of continuous EEG on survival. We assessed the proportions of consents obtained strictly according to the law, of specific waivers for this study obtained from the IRB (early death; relatives' unavailability despite repeated attempts), and the yield of retrieving statements on willingness to research participation. We compared the pr

SUBMITTER: Guinchard M 

PROVIDER: S-EPMC7882163 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature