title: Informed consent for bedside procedures in the pediatric intensive care unit: a preliminary report.
abstract: OBJECTIVE
  No uniform guidelines exist regarding informed consent for bedside procedures in the intensive care unit (ICU), and practice varies widely between institutions. Neither guidelines nor data exist to help pediatric ICU (PICU) directors craft procedural consent policies. We conducted an exploratory study to explore the impact on patients, parents, and healthcare providers of a requirement for informed consent for bedside procedures in the PICU and to describe parental and provider beliefs regarding procedural consent.
  
  
  METHODS
  Prospective, observational and survey-based exploratory study.
  
  
  METHODS
  Single-center, tertiary care, university-affiliated PICU.
  
  
  METHODS
  Children admitted to the PICU and undergoing an invasive bedside procedure.
  
  
  METHODS
  None.
  
  
  RESULTS
  During two 14-day periods, all bedside procedures conducted in the PICU were identified. Consent forms were reviewed, and parents and the healthcare providers who participated in the consent discussion were invited to complete a brief verbal questionnaire regarding the consent process. Quantitative data are presented using descriptive statistics and qualitative data were analyzed using thematic coding. During the study period, 50 bedside procedures were performed. Informed consent was not obtained for two emergent procedures. Only the first procedure on a child was included in the study, leaving 41 informed consent discussions for analysis. Consent was obtained in person in 33 cases (80%) and over the phone for the remainder. The median reported duration of the informed consent discussion was 5 mins. Ninety-six percent of parents correctly recalled what procedure had been performed, and 92% correctly recalled at least one reason for the procedure, but only 58% recalled at least one risk of the procedure. Parents viewed themselves as the primary decision makers, and many parents believed that their refusal of consent would be honored even if it would potentially harm the child. However, no parent refused or even significantly resisted giving consent for a procedure recommended by their child's healthcare provider.
  
  
  CONCLUSIONS
  Parental consent for invasive bedside procedures in the PICU can be obtained reliably and without posing an undue time burden on healthcare providers. Most parents perceive a real decision making opportunity surrounding invasive procedures, but agree readily to the recommendations of their healthcare providers.
authors.affiliation: Department of Pediatrics, Columbia University, New York, NY, USA.
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Marsillio
authors.forename: Marilyn C
authors.initials: MC
authors.lastname: Morris
mesh_terms: D019538:Health Care Surveys; D006801:Humans; D007258:Informed Consent; D015278:Intensive Care Units, Pediatric; D010290:Parents; D019095:Point-of-Care Systems; D011446:Prospective Studies; D020458:Third-Party Consent