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Informed consent in critically ill adults participating to a randomized trial
Milène Guinchard1, Loane Warpelin-Decrausaz2, Kaspar Schindler3
1Department of Clinical Neuroscience, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Brain and Behavior
|December 3, 2020
Summary
Swiss research law updates patient protection but lacks clarity on consent waivers. A study on critically ill adults found waivers crucial, suggesting a need for clearer guidelines and public awareness campaigns for research participation.
Area of Science:
- Medical Ethics
- Clinical Trials
- Health Law
Background:
- The 2014 Swiss law on research enhances patient protection with specific emergency requirements, but the role of consent waivers remains ambiguous.
- This ambiguity impacts the recruitment and generalizability of results in clinical trials involving critically ill patients.
Purpose of the Study:
- To explore the practical implications of the 2014 Swiss research law on patient consent in a randomized controlled trial (RCT) for critically ill adults.
- To assess the proportion of patients included via consent waivers versus informed consent.
- To evaluate the effectiveness of searching for patients' willingness to participate in research.
Main Methods:
- A multicenter RCT investigating the impact of continuous electroencephalography (EEG) on survival in critically ill adults.
- Prospectively collected consent data were analyzed to determine proportions of informed consents, IRB-approved waivers (due to early death or relative unavailability), and retrieved statements of willingness to participate.
- Consent refusal rates were compared with those of recent trials.
Main Results:
- Out of 402 recruited patients, 368 were analyzable after exclusions. Specific waivers facilitated the inclusion of 134 patients (36.4%).
- Informed consent was obtained for the remaining patients. Only 14.1% of patients had a documented statement of willingness to participate in research.
- Consent refusal rates varied significantly (0%-23%) in recent trials, influenced by waiver policies.
Conclusions:
- Explicit provisions for consent waivers are necessary to avoid losing a significant patient proportion and to ensure the generalizability of research findings.
- The low yield of retrieving statements on willingness to participate questions its current utility, advocating for public awareness initiatives.
- Clearer legal frameworks for consent waivers in emergency research are needed.
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