title: Factors affecting consent in pediatric critical care research.
abstract: OBJECTIVE
  Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors.
  
  
  METHODS
  A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters.
  
  
  RESULTS
  We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88).
  
  
  CONCLUSIONS
  This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.
authors: Department of Pediatrics, University of Ottawa, Ottawa, Canada. menon@cheo.on.ca
authors: Kusum
authors: K
authors: Menon
authors: Roxanne E
authors: RE
authors: Ward
authors: Isabelle
authors: I
authors: Gaboury
authors: Margot
authors: M
authors: Thomas
authors: Ari
authors: A
authors: Joffe
authors: Karen
authors: K
authors: Burns
authors: Deborah
authors: D
authors: Cook
mesh_terms: D035843:Biomedical Research; D002170:Canada; D002675:Child, Preschool; D015331:Cohort Studies; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000706:statistics & numerical data*; D015278:Intensive Care Units, Pediatric; D011446:Prospective Studies; D019727:Proxy