Abstract 17: Perception of Risk in Resuscitation Research
Introduction - Federal regulations allow research in emergent, life threatening situations with an exception from informed consent when specific conditions are met, and after a process of community consultation and public disclosure. No such process has yet taken place for pediatric research. Understanding parental perception of risk in pediatric resuscitation research is the necessary first step to developing appropriate consultation methods and content for pediatric resuscitation research.
Methods - Structured interviews with 150 parents of children in various medical settings will be conducted between 5/8/06 and 7/30/06. 49 interviews have been completed and analyzed to date. Responses were via a 5-point Likert scale; qualitative explanations are recorded verbatim. Statistical analysis with chi-square or Kruskal-Wallace test and with NVivo qualitative analysis software.
Results - 27/43 parents were interviewed in the pediatric intensive care unit and 22/43 in outpatient settings. Parents rated the importance of pediatric clinical research in the emergency setting less highly than in the non-emergency setting (p<0.01). Parents responded neutrally to the statement: “It is important to do medical research involving children in emergency situations” (Likert scale median and modal response = 3: “neither agree nor disagree”). Parents who rated their children as less healthy placed a higher importance on emergency research (p < 0.05). Parents rated a randomized trial of two accepted medicines for a child with a seizure as “a little bit risky” (Likert scale 2) and a randomized trial of two accepted medicines given during CPR as “moderately risky” (Likert scale 3). The most common objections to research in general were fear of side effects and fear of being a “guinea pig.” The most common objection to research in the emergency setting was that it would delay medical care.
Conclusions - Success in pediatric emergency research depends on understanding and acceptance of this type of research by parents. Community consultation and public disclosure processes should consider that parents may underestimate the importance of emergency research. Parental fears that resuscitation research will delay medical care must be specifically addressed.