© Penn Medicine SP Program
Obtaining Consent for Child to be Enrolled in a Research Study
Perelman School of Medicine at the University of Pennsylvania Standardized Patient Exercise
Background Information for Consent Simulation Participant
You are a Research Coordinator in CHOP’s PICU and you will be speaking with Michelle Waverly, mother of 12-month-old Maxine.
Presenting Situation:
The patient is a 12-month-old previously healthy female infant with bronchiolitis, found unresponsive at home, requiring 3 minutes of CPR. The child was taken via ambulance to CHOP and admitted to the PICU ten hours ago. The child is intubated, mechanically ventilated, with an arterial catheter, triple lumen central venous catheter, and is on Dopamine infusion of 5 mcg/kg/min and Epinephrine infusion of 0.1 mcg/kg/min to support her blood pressure and perfusion. As the Research Coordinator, you are informed that she meets eligibility criteria for HALF-PINT (Heart and Lung Failure-Pediatric Insulin Titration Trial), with two blood glucose measurements that have been 180mg/dL and 170mg/dL, respectively, and no known underlying metabolic condition. The child and parent have been in the ICU for approximately 10 hours.
Your task (as the PICU Research Coordinator):
Approach the parent to participate in the HALF-PINT study. Obtain informed consent and address the parent’s concerns.
You have already gained permission from the clinical team to approach the parent, and are prepared to randomize the child to one of the two TGC target ranges, if the parents’ consent to participation in the study.
