Informed consent in critically ill adults participating to a randomized trial. Issue 2 (3rd December 2020)

• Record Type: Journal Article
• Authors: Guinchard, Milène; Warpelin‐Decrausaz, Loane; Schindler, Kaspar; Rüegg, Stephan; Oddo, Mauro; Novy, Jan; Alvarez, Vincent; Rossetti, Andrea O.
• Is Part Of: Brain and behavior. Volume 11:Issue 2(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-03
• Subjects: Declaration of Helsinki -- electroencephalography -- Ethic Commission -- IRB -- Switzerland; Neurology -- Periodicals; Neurosciences -- Periodicals; Psychology -- Periodicals; Psychiatry -- Periodicals; 616.8005
• DOI: 10.1002/brb3.1965
• Languages: English
• ISSNs: 2162-3279

Abstract

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. Abstract : This study analyzes the informed consent flow in a multicenter RCT carried out in critically ill adults and shows that data from 7% of recruited subjects had to be discarded due to lack of consent; this modified the primary endpoint (mortality). Furthermore, 36% of recruited subjects could be analyzed only following a specific waiver accorded from the Ethics Commission. These results highlight critical issues regarding generalizability of results, namely the importance of providing specific waivers in this clinical context and to address drop‐out rates due to lack of consents.