ICU research: the impact of invasiveness on informed consent
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Fabienne Gigon Paolo Merlani Catherine Chenaud Bara Ricou
ORIGINAL
ICU research: the impact of invasiveness on informed consent
Abstract Purpose: Studies 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 Electronic supplementary material The online version of this article choice of who should give consent (doi:10.1007/s00134-013-2908-x) contains and on the modalities of informed supplementary material, which is available consent. Methods: At ICU disto authorized users. charge, randomized pairs of patients and relatives were asked to answer a F. Gigon ()) questionnaire about informed consent APSI Department, Intensive Care, for research. One group received a University Hospitals of Geneva, vignette of a noninvasive study; the Rue Gabrielle-Perret-Gentil 4, 1211 Geneva 14, Switzerland other, of an invasive study. Each e-mail: [email protected] study comprised two scenarios, feaTel.: ?41-22-3827459 turing either a conscious or Fax: ?41-22-3827470 unconscious patient. Multivariate models assessed independent factors P. Merlani C. Chenaud B. Ricou related to their preferences. Results: Department of Anesthesiology, A total of 185 patients (40 %) and Pharmacology and Intensive Care, Service of Intensive Care, University 125 relatives (68 %) responded. The Hospitals and the University of Geneva, invasiveness of a study had no impact Geneva, Switzerland on which people were chosen to give consent. This increased the desire to Present Address: get more than one person to give P. Merlani consent and decreased the acceptance Intensive Care Unit-Ospedale Regionale di Lugano, Lugano, Switzerland of deferred or two-step consent. Up to Received: 26 June 2012 Accepted: 15 March 2013 Published online: 24 April 2013 Ó Springer-Verlag Berlin Heidelberg and ESICM 2013
Introduction Research is essential to further medical knowledge and eventually improve patient care [1]. Informed consent— respectful of a patient’s autonomy—is a key ethical requirement in human research. It implies a competent patient, complete information about the study (including
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. Conclusions: Study 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. Keywords Research ethics Research on research Unconscious patient Relatives Surrogate
all invasive procedur
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