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

Details

Serval ID
serval:BIB_D1FD84C9F556
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Informed consent in critically ill adults participating to a randomized trial.
Journal
Brain and behavior
Author(s)
Guinchard M., Warpelin-Decrausaz L., Schindler K., Rüegg S., Oddo M., Novy J., Alvarez V., Rossetti A.O.
ISSN
2162-3279 (Electronic)
Publication state
Published
Issued date
02/2021
Peer-reviewed
Oui
Volume
11
Number
2
Pages
e01965
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.
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 proportion of consent refusals with those of recent trials in similar environments, and estimated the potential impact on study results.
Of 402 recruited patients, six had double inclusions, one died before intervention, and 27 (6.7%, alive on long-term) were excluded following consent refusal or withdrawal, leaving 368 analyzable patients. Specific waivers allowed inclusion of 134 (36.4%) patients, while informed consents were obtained for all others. A statement of willingness to research participation was found in only 14.1%. In recent trials, consent refusal oscillated between 0%-23%, according to different waiver policies.
Consent waivers should be specifically foreseen to prevent losing a potentially relevant proportion of patients reaching endpoints, and ensure results generalizability. The yield of looking for willingness to research participation seems low; this questions its current usefulness and calls for a public awareness campaign.
Keywords
Declaration of Helsinki, Ethic Commission, IRB, Switzerland, electroencephalography
Pubmed
Web of science
Open Access
Yes
Create date
21/12/2020 16:21
Last modification date
03/03/2021 7:25
Usage data