• Margot Thomas and Kusum Menon.
• Children's Hospital of Eastern Ontario, Ottawa, ON. thomas@cheo.on.ca
• Dynamics. 2013 Jan 1;24(3):18-24.

UnlabelledPediatric clinical research is dependent on obtaining consentfrom the parents or legal guardian of eligible patients. Little is known about parents' perspectives and the process by which they make the decision to enroll their child in a pediatric critical care trial.ObjectiveTo describe the experience of parents/legal guardians who consented or declined consent for their child to be enrolled in a pediatric critical care research study. Factors that influenced parents' decisions and suggestions for improving and modifying the consent process were explored.MethodThis study used a qualitative descriptive research design. Seven semi-structured qualitative interviews were conducted with parents who had given or declined consent for their child to participate in a clinical research study while their child was in a pediatric critical care unit in one of two Canadian pediatric teaching hospitals. Parents were interviewed within 48 hours of their child's transfer from the PICU to a hospital ward unit. The interviews were audio recorded, transcribed, and analyzed using a content analysis method.ResultsParental decision-making related to research consent in the context of pediatric critical care is influenced by specific characteristics of the consent encounter (timing, location, and information), parent (emotional state, decision-making style, familiarity with environment, past experience, and personal motivation), child (condition and response to pain/needles) and study (risk, method, burden, and benefit). Parents identified that the timing and ways in which they received information during the consent encounter could be improved.ConclusionPediatric critical care researchers can improve the parental consent encounter experience by considering how parents perceive the approach to consent for a research trial for their child to balance the need to support parents with the need for participants in pediatric critical care research trials.

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