PEDIATRICS Vol. 115 No. 3 March 2005, pp. 829 (doi:10.1542/peds.2004-2725)
Waiver of Prospective Consent for Pediatric Resuscitation Research: In Reply
Marilyn C. Morris, MDDepartment of Pediatrics,
Children's Hospital of New York-Presbyterian,
New York, NY 10032
We greatly appreciate the comments from Stromberg et al and their description of 1 approach to obtaining prospective informed consent for pediatric resuscitation research that involves minimal risk. For the study of interposed abdominal compression cardiopulmonary resuscitation that they describe, the investigators seek prospective informed consent from parents of children scheduled for cardiac surgery at a preoperative visit.1 Stromberg et al provide important preliminary data regarding the number of parents and patients who provide consent and assent and the reactions of parents to the informed-consent discussion, reinforcing and supplementing the findings in our study.2
Seeking consent at a preoperative visit preserves parental decision-making to a large degree, but caution is still needed to ensure that consent is really informed and free of coercion. Parents who are entrusting their child to a medical center for correction of congenital cardiac disease are in a vulnerable position and may be reluctant to decline participation for fear of losing the favor of the caregivers. The extent to which the consent is truly informed must also be questioned, because the parents do not expect that the study will apply to their child. Nonetheless, with proper attention to these and other details, the approach by Stromberg et al may represent an optimal choice when the risk of intervention is minimal and the frequency of the intervention is relatively common.
As the Stromberg et al study progresses, it will be informative to learn how many patients for whom consent was sought are enrolled in the trial. This information will help future investigators estimate the financial cost of seeking informed consent from every preoperative patient and will indicate the number of parents exposed to the informed-consent process whose children will not become eligible for participation. Additional critical data could be obtained from the parents of children who do participate in the trial to determine how well they understood the trial based on an informed-consent discussion that took place without their expectation that it would actually apply to their child.
Again, we are in agreement with the supplementary discussion from Stromberg et al. We look forward to the results of their study and continue to seek ethically sound ways to perform interventional studies in the pediatric cardiac arrest setting.
REFERENCES
- Stromberg D, Tortoriello T, Adame T. Waiver of prospective consent for pediatric resuscitation research.
Pediatrics. 2005;115
:828
–829
[Free Full Text] - Morris MC, Nadkarni VM, Ward FR, Nelson RM. Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest.
Pediatrics. 2004;114
:776
–781
[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics
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