ArticleIntensive care medicine2006
Informed consent for research in ICU obtained before ICU admission.
Article in Intensive care medicine, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Challenges in the conduct of randomised controlled trials in cardiogenic shock complicating acute myocardial infarction.Journal of geriatric cardiology : JGC · 2022Article
- Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.Annals of translational medicine · 2017Article
- Ethical challenges and solutions regarding delirium studies in palliative care.Journal of pain and symptom management · 2014Review
- ICU research: the impact of invasiveness on informed consent.Intensive care medicine · 2013Article
- Ability of family members to predict patient's consent to critical care research.Intensive care medicine · 2007Article
- Year in Review in Intensive Care Medicine, 2006. III. Circulation, ethics, cancer, outcome, education, nutrition, and pediatric and neonatal critical care.Intensive care medicine · 2007Review
- Doing research on the ethics of doing research.Critical care (London, England) · 2007Article
- Research in critically ill patients: standards of informed consent.Critical care (London, England) · 2007Article
- Informed consent for research obtained during the intensive care unit stay.Critical care (London, England) · 2006Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo analyze the procedure of the informed consent for ICU research obtained before ICU admission.
designProspective, open, observational study.
setting20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU. PATIENTS: Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.
interventionsPatients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward. MEASUREMENTS AND
resultsBetween January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure.
conclusionsEven when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.
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Registered trials
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