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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Prospective observational study in three Dutch ICUs.
  
  
  METHODS
  714 consecutive ICU patients. Analysis was restricted to 211 patients who were incapacitated for more than 24h after ICU admission.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: Denise P
authors.initials: DP
authors.lastname: Veelo
authors.forename: Peter E
authors.initials: PE
authors.lastname: Spronk
authors.forename: Michael A
authors.initials: MA
authors.lastname: Kuiper
authors.forename: Johanna C
authors.initials: JC
authors.lastname: Korevaar
authors.forename: Peter H J
authors.initials: PH
authors.lastname: van der Voort
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Schultz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D005060:Europe; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D018579:Patient Selection; D011446:Prospective Studies; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D020458:Third-Party Consent / Q000331:legislation & jurisprudence*