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

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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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Acknowledgements

We thank our research nurses José Hofhuis Msc (Gelre Hosiptals) and Matty Koopmans (Medical Center Leeuwarden) for their valuable contribution to this study in interviewing many of the patients and their relatives whose results were included.

Author information

Authors and Affiliations

  1. Department of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

    Denise P. Veelo & Marcus J. Schultz

  2. Department of Intensive Care Medicine, Gelre Hospitals Location Lukas, Apeldoorn, The Netherlands

    Peter E. Spronk

  3. Department of Intensive Care Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands

    Michael A. Kuiper & Peter H. J. van der Voort

  4. Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

    Johanna C. Korevaar

  5. Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

    Marcus J. Schultz

Authors
  1. Denise P. Veelo
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  2. Peter E. Spronk
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  3. Michael A. Kuiper
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  4. Johanna C. Korevaar
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  5. Peter H. J. van der Voort
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  6. Marcus J. Schultz
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Corresponding author

Correspondence to Marcus J. Schultz.

Additional information

This article is discussed in the editorial available at: http://dx.doi.org/10.1007/s00134-006-0386-0

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Veelo, D.P., Spronk, P.E., Kuiper, M.A. et al. A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study. Intensive Care Med 32, 1845–1850 (2006). https://doi.org/10.1007/s00134-006-0384-2

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