PEDIATRICS Vol. 115 No. 3 March 2005, pp. 828a-829 (doi:10.1542/peds.2004-2429)
Waiver of Prospective Consent for Pediatric Resuscitation Research
Daniel Stromberg, MDTia Tortoriello, MD
Department of Pediatrics,
University of Texas Southwestern Medical Center,
Dallas, TX 75235,
Division of Cardiology,
Children's Medical Center, Dallas,
Dallas, TX 75235
Tracine Adame, RN
Department of Clinical Research,
Children's Medical Center, Dallas,
Dallas, TX 75235
To the Editor.—
We read with interest the recent Pediatrics article "Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest."1 The article described parental and hospital staff opinions of informed consent relevant to study of induced hypothermia after pediatric cardiac arrest. Focus groups identified attempts to obtain informed consent at the time of hospital or intensive care unit (ICU) admission as particularly problematic. Difficulties with this a priori approach included (1) lack of parental receptivity to research/consent conversations during the stress of admission, (2) inattention to the consent document and its contents when parents believe the likelihood of study applicability to their child is low, (3) anxiety generation in a large number of parents forced to contemplate the cardiac arrest of their child, and (4) extraordinary labor demands and logistic difficulties associated with obtaining prospective consent from all patients admitted to either the hospital or ICU.1
We recently began a study of pediatric interposed abdominal compression cardiopulmonary resuscitation (CPR). Based on existing adult and pediatric data, the study poses minimal risk to children and may be beneficial when results of standard CPR are poor. Prospective informed consent deemed necessary by our institutional review board has been attempted at cardiac ICU admission or at the time of the preoperative outpatient visit 1 to 3 days before cardiac surgery. The preoperative visit is structured necessarily to include clinical and laboratory patient evaluation, the consent process for cardiac surgery and blood transfusion, a tour of the cardiac ICU and inpatient facilities, instruction regarding nothing-by-mouth status on the day of surgery, and introduction to pediatric cardiology social work and child-life specialists. Discussion of research participation comes at the end of this information-intensive experience.
We speculated that adding a research-consent process, which deals with an unpleasant subject, to an otherwise busy preoperative visit places an additional emotional burden on stressed parents and families. Therefore, to better understand the problems we faced in obtaining prospective consent for our investigation, research coordinators at our hospital recorded the responses of parents to the prospective consent process.
Beginning in March 2004, parents or guardians of children admitted to our cardiac ICU or seen in the cardiology clinic before congenital heart surgery were approached for consent to participate in the interposed abdominal compression CPR study. Approximately 150 children were eligible for the investigation, and 96 families were offered enrollment. Consent or assent (for those >9 years old) was provided by 62 families (65%). In 1 such case, the patient's mother became tearful but gave consent nonetheless after hearing details of the investigation. No child of appropriate age for assent declined participation in the study, nor were there patients who assented but were overruled by parents or guardians. Thirty-four families (35%) decided not to participate: 17 did so after listening to an explanation of the study and provided no reason for nonparticipation; 11 did not wish to hear about CPR research of any kind; 3 either stated that they were "overwhelmed" or began to cry; 2 believed their child would not need CPR; and 1 thought that the new form of CPR could be harmful to their child given an underlying hematologic disorder.
These data suggest that parents or guardians are willing to grant consent for their child to participate in minimal-risk resuscitation research (as are the potential participants themselves) despite the difficulties of prospective consent. However, the degree to which consent is truly "informed" when the likelihood of participation is deemed low by the parent is questionable. Moreover, an emotional price is paid by the families who are forced to contemplate a worst-case scenario for their loved one regardless of whether they consent. Among those who refused to take part, many did so before even hearing about the study because their psychological state precluded such grim discussion. Although this cohort undoubtedly includes families who would not ever grant consent for research participation and those who were inattentive by the time consent was requested, it is conceivable that some families adopted a defensive posture in response to a decidedly negative stimulus.
Institutional review boards are charged with the responsibility of balancing community protections from unethical research against the community need to receive optimal medical care through advanced investigation. In pediatric resuscitation research, which poses minimal risk and offers potential benefit, strict institutional review board requirements for prospective consent may actually do a disservice to patients and families. The article by Morris et al1 provides direct evidence of this from parents of children either admitted to the ICU or resuscitated from cardiac arrest. Our experience delineated herein, although only descriptive and nonscientific, is also confirmatory of this point. Few families objected to the interposed abdominal compression CPR study, but many appeared traumatized by the prospective consent discussion itself. The true emotional burden placed on families by this requirement may never be accurately known.
We therefore suggest that simply because prospective consent can be obtained (albeit at great cost) for minimal-risk CPR studies, it should not be required in every case. Rather, other forms of patient protection as outlined by the Food and Drug Administration and Department of Health and Human Services may be used.2 Morris et al and the Children's Hospital of Philadelphia Institutional Review Board wisely used parental attitudes regarding research consent at the time of ICU admission to develop ethical methods for consultation with the inpatient hospital community as a prerequisite for institutional review board exemption from prospective informed consent. We believe a similar process should be applied to other minimal-risk CPR studies in which there is potential benefit to the subject. Waiver of prospective consent in these narrow circumstances would decrease the considerable expense and difficulty associated with conducting these much-needed investigations and reduce the stresses on families already strained by the need to admit their child to an ICU.
REFERENCES
- 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] - Exception from informed consent requirements for emergency research. 21 Federal Register 50.24 (2004)
PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics
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  M. C. Morris Waiver of Prospective Consent for Pediatric Resuscitation Research: In Reply Pediatrics, March 1, 2005; 115(3): 829 - 829. [Full Text] [PDF]
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