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01-11-2006 | Original

A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study

Authors: Denise P. Veelo, Peter E. Spronk, Michael A. Kuiper, Johanna C. Korevaar, Peter H. J. van der Voort, Marcus J. Schultz

Published in: Intensive Care Medicine | Issue 11/2006

Abstract

Objectives

To determine the effect of a change in the “Dutch Directive on Medical Research Involving Human Subjects” (DD) on the number of eligible intensive care unit (ICU) patients for medical research. In addition, we determined how family members experience their role as acting representative for giving informed consent, and in turn whether patients feel their representatives would do well representing them.

Design and setting

Prospective observational study in three Dutch ICUs.

Participants

714 consecutive ICU patients. Analysis was restricted to 211 patients who were incapacitated for more than 24 h after ICU admission.

Measurements and results

The old DD left 45.5% of patients without a legal representative; with the new DD this figure declines to 8.1%. Older age was significantly associated with the impossibility of obtaining informed consent in the old DD; after the change there was no effect of age. The median grade of confidence that representatives had in giving informed consent for incapacitated patients was 8.0 (IQR 7.0–9.0) on a scale from 0 to 10. Patients gave an equal median grade to their representatives.

Conclusion

When patients' adult children are not legally allowed to give informed consent, older patients are excluded from medical research, causing selection bias. The change in the DD has increased the number of surrogates allowed to give informed consent. Representatives felt very confident in their ability to represent the patients. In turn patients were equally confident that their representatives were able to represent them.

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Title: A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study
Authors: Denise P. Veelo
Peter E. Spronk
Michael A. Kuiper
Johanna C. Korevaar
Peter H. J. van der Voort
Marcus J. Schultz
Publication date: 01-11-2006
Publisher: Springer-Verlag
Published in: Intensive Care Medicine / Issue 11/2006
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-006-0384-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study

Abstract

Objectives

Design and setting

Participants

Measurements and results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objectives

Design and setting

Participants

Measurements and results

Conclusion

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