K Sarah Hoehn

Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board–Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials

OBJECTIVE. To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. METHOD. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. RESULTS. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1,

The Children's Hospital of Philadelphia's experience with donation after cardiac death

180–1425; study 2,

Parental decision-making in congenital heart disease.

0–500; and study 3,

Advising parents about children's participation in clinical research

0–100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified ≥1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. CONCLUSION. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Parents should not be excluded from decisions to forgo life-sustaining treatments!

Objective:To describe our experience with pediatric donation after cardiac death. Design:Retrospective chart review of all cases of donation after cardiac death from 1995 to 2005. Setting:The Children’s Hospital of Philadelphia pediatric intensive care unit. Patients:Twelve patients who were pediatric organ donors after cardiac death. Interventions:None. Measurements and Main Results:Charts for 12 patients were located, and donation after cardiac death was confirmed. There were two females and ten males. Patient age ranged from 1 to 17 yrs (mean 8 yrs). Four patients had severe traumatic brain injury, and eight patients had hypoxic ischemic encephalopathy. The organs procured were 24 kidneys, eight livers, four lungs, and one pancreas. The organs transplanted were 23 kidneys, four livers, and one pancreas. Ten of 12 cases of withdrawal of life-sustaining support occurred in the operating room area; the other two occurred in the holding area and the postanesthesia care unit. Children received a wide range of medications at the time of extubation. No neuromuscular blockers were used. The time of extubation to time of death ranged from 4 mins to 30 mins, with a mean of 14.5 mins. Death was declared based on cardiac asystole confirmed by auscultation and transthoracic impedance, with organ procurement initiated 5 mins later. Regarding who initiated conversation about donation after cardiac death, nine cases were family initiated, one case was physician initiated, and in two there was a collaborative approach with the physician and representative from the organ procurement organization. Of the organs transplanted, all organs other than one kidney and one split liver graft were functioning at 1 yr post-transplant. Conclusions:Pediatric donation after cardiac death can be performed successfully; its impact on end-of-life care and bereavement needs further investigation.

Euthanasia, eye of the beholder?

OBJECTIVE To explore whether prenatal diagnosis of congenital heart disease is associated with lower levels of parental distress and greater satisfaction with decisions about cardiothoracic surgery when compared to postnatal diagnosis. METHODOLOGY A combined quantitative-qualitative design was used. Participants included the parents of 31 neonates (30 mothers and 22 fathers) admitted to the cardiac intensive care unit between 1 November 2001 and 1 May 2002 for repair of congenital cardiac malformations. Participants completed self-report measures of anxiety, optimism, and life events pre-operatively, and semi-structured qualitative interviews assessing satisfaction with decision-making within 1 week of the operation. RESULTS At the time of surgery, mothers of neonates receiving the diagnosis prenatally did not differ from mothers of neonates receiving the diagnosis postnatally on measures of anxiety, optimism, and life events. Fathers of neonates receiving the diagnosis prenatally, however, reported more optimism, lower state and trait anxiety, and fewer negative life events than fathers of neonates receiving the diagnosis postnatally. When we analyzed the interviews, we found that, regardless of the timing of the diagnosis, parents felt as though they made a genuine choice for their baby to have surgery. CONCLUSIONS In this pilot study, fathers who learned prenatally that their child had a congenital cardiac malformation were less distressed than those who discovered this fact only postnatally. From the parental perspective, nonetheless, distress and urgency do not impair their ability to make decisions about neonatal cardiac surgery.

Feeling Burnt out? You Are Not Alone…

The pediatrician can assist a parent in evaluating the risks and potential benefits of clinical research, assessing the qualifications of the research team, clarifying a childs understanding of the research, and supporting the parent and child throughout the research study. To perform this role, the pediatrician should review with the parent and child (if appropriate) the consent document and any other available information about the research. If there are unanswered questions, the pediatrician should encourage a parent to contact the researcher, or offer (with the parents permission) to contact the researchers on the parents behalf.