A paradigm for inpatient resuscitation research with an exception from informed consent*


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Abstract

Objective:Resuscitation research with an exception from informed consent (EFIC) has not been reported in the inpatient or pediatric setting, and little practical information exists to guide application of EFIC regulations to inpatient or pediatric research. The objective of this study was to assess the feasibility of conducting inpatient pediatric resuscitation research with EFIC using handouts to communicate with parents of potential participants and to determine how many parents would likely allow their child to participate in such research.Design:Verbal questionnaire.Setting:Pediatric intensive care units.Participants:Parents of pediatric intensive care unit patients.Interventions:Three one-page handouts described proposed studies; version 1 described a trial of a new medication given during cardiac arrest, and versions 2a and 2b described of a trial of induced hypothermia, with version 2a in paragraph format and version 2b in bullet format. We asked parents of pediatric intensive care unit patients to review the handouts, and then we administered a verbal questionnaire to assess parental reactions to the handouts and to determine how many parents would allow their child to participate.Measurements and Main Results:One or both parents of 91 patients were asked to participate; 100% agreed. Sixty-three percent said they would likely allow their child to participate in resuscitation research with EFIC if they were given a prospective opportunity to opt out. Parents who reviewed version 2b (bullet format) were more likely than parents who reviewed version 2a (paragraph format) to say that they would let their child participate. Parents were more supportive of a trial of induced hypothermia than of a trial of a new medication given during cardiopulmonary resuscitation. Parents endorsed conducting the community consultation process for inpatient resuscitation research with families and healthcare providers of critically ill patients.Conclusions:Inpatient pediatric resuscitation research is feasible using handouts to inform parents of a study and provide a prospective opportunity to opt out. Succinct, bullet-format handouts will yield higher participation rates than paragraph-format handouts.

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