Published online September 1, 2004
PEDIATRICS Vol. 114 No. 3 September 2004, pp. 776-781 (doi:10.1542/peds.2004-0482)
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Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest

Marilyn C. Morris, MD*, Vinay M. Nadkarni, MD*,{ddagger}, Frances R. Ward, RN, MSN§ and Robert M. Nelson, MD, PhD*,{ddagger}

* Department of Anesthesia and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
{ddagger} Departments of Anesthesia and Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
§ University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania

Objectives. When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only after a community consultation and public disclosure process and the granting of exception from informed consent from the federal government. The applicability of exception from informed consent to pediatric resuscitation research has not been described. The objectives of this study were 1) to perform a community consultation and public disclosure process specific to a trial of induced hypothermia immediately after pediatric cardiac arrest and 2) to determine the applicability of exception from informed consent to randomized, controlled trials of emergency interventions after resuscitation from inpatient pediatric cardiac arrest.

Methods. Focus groups, information sheets with options for written responses, posted notices, e-mails, and telephone conversations with parents of critically ill children and hospital staff were conducted at a tertiary care children's hospital. Data were stored, organized, and retrieved using NVivo qualitative analysis software (QSR International).

Results. In focus groups (n = 8), parents (n = 23) and hospital staff (n = 33) concluded that prospective informed consent is not feasible for a trial of induced hypothermia after inpatient pediatric cardiac arrest. Focus group participants endorsed exception from informed consent for a trial of induced hypothermia but only if study information is easily available prospectively and if all parents have an explicit opportunity to decline participation in a verbal conversation before study enrollment. Separate from and without knowledge of the focus group results, 7 (100%) of 7 parents of past or current patients and 21 (50%) of 42 hospital staff who provided written opinions endorsed exception from informed consent for this study. Five (12%) of 42 hospital staff opposed, and 16 (38%) of 42 were neutral. In telephone conversations, 14 (70%) of 20 parents of children who were previously resuscitated from cardiac arrest endorsed exception from informed consent for this study, 3 (15%) of 20 opposed, and 3 (15%) of 20 were unsure.

Conclusions. Community consultation for inpatient resuscitation research can be conducted in a children's hospital, with hospital staff and parents of patients as the relevant community. Exception from informed consent is necessary and appropriate for a randomized trial of induced hypothermia begun within 30 minutes after pediatric cardiac arrest. A process in which families are informed prospectively and have a pre-enrollment option to decline participation will likely be acceptable to families, health care providers, and the institution.

Key Words: cardiopulmonary resuscitation • ethics • informed consent • pediatric

Abbreviations: FDA, Food and Drug Administration • DHHS, Department of Health and Human Services • IRB, institutional review board • PICU, pediatric intensive care unit

Accepted Apr 14, 2004.


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