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. Public disclosure consisted of a brochure and a poster in all PICU waiting rooms. These materials described risks and benefits of the trial, that no consent would be sought, how to "opt out," and how to provide feedback. A verbal questionnaire was administered to parents of potential patients during the trial to evaluate the public disclosure process.


RESULTS
Eighty-one percent of 93 parents were aware of the ongoing trial. Seventy-six of 93 remembered seeing the brochure; of these, 26% did not read, 39% read quickly, and 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. Sixty-seven percent reported that they would want to participate in the study, 9% would not, and 24% were undecided. Of the 7 parents who did not want to participate, 3 had opted out and 4 were unaware that they could opt out.


CONCLUSIONS
Parents endorsed resuscitation research with an exception from informed consent. Public disclosure yielded >80% parental awareness. Efforts should be made to ensure awareness of the ability to opt out.
Department of Pediatrics, Division of Cardiac Critical Care, Medical City Children's Hospital, Dallas, Texas, USA. tiaraymond@me.com
Tia Tortoriello
TT
Raymond
Timothy Glenn
TG
Carroll
Glenda
G
Sales
Marilyn Cummings
MC
Morris
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods; D030881:Disclosure; D005260:Female; D006801:Humans; D007223:Infant; D007258:Informed Consent; D015278:Intensive Care Units, Pediatric; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012151:Resuscitation / Q000379:methods*