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A paradigm for inpatient resuscitation research with an exception from informed consent
Marilyn C Morris1, Ruth L Fischbach, Robert M Nelson
1Department of Pediatrics, Children's Hospital of New York-Presbyterian, Columbia University, New York, NY, USA.
Insights
Inpatient pediatric resuscitation research is feasible using handouts to inform parents and allow opt-out. Bullet-format information increases parental consent for critically ill children.
Area of Science:
- Pediatric Critical Care Medicine
- Bioethics
- Clinical Research Methodology
Background:
- Exception From Informed Consent (EFIC) in resuscitation research is under-explored in pediatric inpatient settings.
- Limited practical guidance exists for applying EFIC regulations to pediatric and inpatient research.
Purpose of the Study:
- To assess the feasibility of conducting inpatient pediatric resuscitation research using EFIC.
- To evaluate the use of handouts for parental communication in EFIC research.
- To determine parental willingness to enroll children in such studies.
Main Methods:
- A verbal questionnaire was administered to parents of children in pediatric intensive care units.
- Parents reviewed one-page handouts describing hypothetical resuscitation research scenarios (medication trial, hypothermia trial).
- Handout formats included paragraph and bullet points.
Main Results:
- 100% of parents approached agreed to participate in the study.
- 63% of parents indicated they would likely consent to their child's participation in resuscitation research with an opt-out option.
- Bullet-format handouts (version 2b) led to higher reported consent rates compared to paragraph-format handouts (version 2a).
- Parents showed greater support for hypothermia trials over medication trials during cardiopulmonary resuscitation.
Conclusions:
- Inpatient pediatric resuscitation research utilizing EFIC is feasible.
- Informational handouts providing an opt-out opportunity effectively facilitate parental consent.
- Bullet-point format handouts enhance parental willingness to enroll children in critical care research.
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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