Effectiveness of the informed consent process for a pediatric resuscitation trial.

Objective: When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only with an exception from informed consent. Our objectives were (1) to describe the in-hospital community consultation and public disclosure process for a clinical trial and (2) to evaluate our in-hospital public disclosure process.

Methods: Community consultation included parents, providers, and administrators in a PICU via focus groups, conferences, and other methods.