Informed consent in critically ill adults participating to a randomized trial

Milène Guinchard, Loane Warpelin-Decrausaz, Kaspar Schindler, Stephan Rüegg, Mauro Oddo, Jan Novy, Vincent Alvarez, Andrea O Rossetti, Milène Guinchard, Loane Warpelin-Decrausaz, Kaspar Schindler, Stephan Rüegg, Mauro Oddo, Jan Novy, Vincent Alvarez, Andrea O Rossetti

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 proportion of consent refusals with those of recent trials in similar environments, and estimated the potential impact on study results.

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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT03129438.

Keywords: Declaration of Helsinki; Ethic Commission; IRB; Switzerland; electroencephalography.

Conflict of interest statement

On behalf of all authors, the corresponding author states that there is no conflict of interest.

© 2020 The Authors. Brain and Behavior published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Study participants' flow diagram
FIGURE 2
FIGURE 2
Capacity of consent recovery through the different assessment time points. The number of patients regaining their capacity of consent during the mentioned period is illustrated in dark gray, and the number of patients who already recovered their judgment is in light gray. The whole column represents the total of patients able to consent at the respective time‐point
FIGURE 3
FIGURE 3
Proportions of the different types of waivers in the absence of informed consent CHUV

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