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Informed consent for research in ICU obtained before ICU admission

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Abstract

Objective

To analyze the procedure of the informed consent for ICU research obtained before ICU admission.

Design

Prospective, open, observational study.

Setting

20-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.

Interventions

Patients 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 results

Between 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.

Conclusions

Even 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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Acknowledgements

Support was provided solely from institutional and/or departmental sources.

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Authors and Affiliations

  1. Service des Soins Intensifs de Chirurgie, Département APSIC, Geneva University Hospital, Rue Micheli-du-Crest 24, 1211, Geneva 14, Switzerland

    Catherine Chenaud, Paolo Merlani & Bara Ricou

Authors
  1. Catherine Chenaud
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  2. Paolo Merlani
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  3. Bara Ricou
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Corresponding author

Correspondence to Catherine Chenaud.

Additional information

Presented in part at the annual congress of the American Thoracic Society (ATS), May 2003, in Seattle, WA, USA

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Chenaud, C., Merlani, P. & Ricou, B. Informed consent for research in ICU obtained before ICU admission. Intensive Care Med 32, 439–444 (2006). https://doi.org/10.1007/s00134-005-0059-4

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  • DOI: https://doi.org/10.1007/s00134-005-0059-4

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