Abstract 2703: Survey in a Pediatric Resuscitation Trial to Assess the Effectiveness of “In-Hospital Community Consultation and Public Disclosure” Under Exception From Informed Consent Requirements for Emergency Research
Background: Trials of cardiac arrest are impeded by the difficulty of obtaining traditional informed consent. When prospective informed consent is not feasible, clinical research that presents more than minimal risk can only proceed with an exception from informed consent (EFIC). No published pediatric studies have been conducted with an EFIC.
to describe the in-hospital community consultation and public disclosure process for a randomized, controlled trial of vasopressin vs. epinephrine for in-hospital pediatric cardiopulmonary arrest, and
to determine the effectiveness of the in-hospital public disclosure process.
Methods: Community consultation was conducted with parents, patients, providers and administrators in a PICU at a tertiary children’s hospital via focus groups, conferences, and other methodologies. Public disclosure consisted of a brochure given to every parent at PICU admission and a poster in all PICU waiting rooms. These materials described risks and benefits of the trial, that no consent would by sought, how to “opt out,” and how to provide feedback. The research staff attempted to discuss the study with all new admissions. A verbal questionnaire was administered to parents of potential subjects in the PICU during the trial to evaluate the public disclosure process.
Results: Parents of 93 children completed the survey; 10 refused. Eighty-one percent were aware of the ongoing resuscitation trial. Seventy-six of 93 parents remembered seeing the brochure: of these, 26% did not read, 39% read quickly; 35% read carefully. Thirty-seven of 93 parents remembered seeing the poster; of these 51% did not read, 32% read quickly, and 17% read carefully. Over 75% were able to identify the main characteristic of the trial as a new medicine and/or involving CPR. Sixty-seven percent of parents reported that they would want to participate in the study, 9% would not, and 22% were undecided. Of the 8 parents (9%) who did not want to participate, only 3 had opted out; 5 parents were unaware they could opt out.
Conclusions: Parents of PICU patients endorsed resuscitation research with an EFIC. Public disclosure yielded > 80% awareness of the eligible patient population. Particular efforts should be made to ensure awareness of the ability to opt out.