ArticleIntensive care medicine2013
ICU research: the impact of invasiveness on informed consent.
Article in Intensive care medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Pooled it
- Pooled it
- The influence of consent models on recruitment rates in randomised trials in critical care: A systematic review.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Review
- [Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2024Review
- Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.BMJ open · 2022Article
- Barriers and challenges in the process of including critically ill patients in clinical studies.Scandinavian journal of trauma, resuscitation and emergency medicine · 2020Observational
- A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research.EFORT open reviews · 2020Article
- Increasing participation in critical care studies: the need to understand surrogate decision-makers for critically ill patients.Intensive care medicine · 2015Article
- Year in review in Intensive Care Medicine 2013: II. Sedation, invasive and noninvasive ventilation, airways, ARDS, ECMO, family satisfaction, end-of-life care, organ donation, informed consent, safety, hematological issues in critically ill patients.Intensive care medicine · 2014Article
- Research to inform the consent-to-research process.Intensive care medicine · 2013Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeStudies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study's invasiveness on the choice of who should give consent and on the modalities of informed consent.
methodsAt ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.
resultsA total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.
conclusionsStudy invasiveness had no impact on patients' and relatives' preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.
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Registered trials
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