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 24h 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.
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 24h 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.
Authors: E Rivers; B Nguyen; S Havstad; J Ressler; A Muzzin; B Knoblich; E Peterson; M Tomlanovich Journal: N Engl J Med Date: 2001-11-08 Impact factor: 91.245
Authors: F Lemaire; J Bion; J Blanco; P Damas; C Druml; K Falke; J Kesecioglu; A Larsson; J Mancebo; D Matamis; A Pesenti; J Pimentel; M Ranieri Journal: Intensive Care Med Date: 2005-02-15 Impact factor: 17.440
Authors: G R Bernard; J L Vincent; P F Laterre; S P LaRosa; J F Dhainaut; A Lopez-Rodriguez; J S Steingrub; G E Garber; J D Helterbrand; E W Ely; C J Fisher Journal: N Engl J Med Date: 2001-03-08 Impact factor: 91.245
Authors: Roy G Brower; Michael A Matthay; Alan Morris; David Schoenfeld; B Taylor Thompson; Arthur Wheeler Journal: N Engl J Med Date: 2000-05-04 Impact factor: 91.245
Authors: D P Sulmasy; P B Terry; C S Weisman; D J Miller; R Y Stallings; M A Vettese; K B Haller Journal: Ann Intern Med Date: 1998-04-15 Impact factor: 25.391
Authors: Peter Andrews; Elie Azoulay; Massimo Antonelli; Laurent Brochard; Christian Brun-Buisson; Daniel De Backer; Geoffrey Dobb; Jean-Yves Fagon; Herwig Gerlach; Johan Groeneveld; Duncan Macrae; Jordi Mancebo; Philipp Metnitz; Stefano Nava; Jerôme Pugin; Michael Pinsky; Peter Radermacher; Christian Richard Journal: Intensive Care Med Date: 2007-02-14 Impact factor: 17.440
Authors: Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Johan Groeneveld; Goran Hedenstierna; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Philipp Metnitz; Jerôme Pugin; Jan Wernerman; Haibo Zhang Journal: Intensive Care Med Date: 2008-02-29 Impact factor: 17.440
Authors: Damon C Scales; Orla M Smith; Ruxandra Pinto; Kali A Barrett; Jan O Friedrich; Neil M Lazar; Deborah J Cook; Niall D Ferguson Journal: Intensive Care Med Date: 2009-06-24 Impact factor: 17.440