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Background: Since the scientific revolution, systematic child-subject experimentation has evolved, with regard not only to scientific methodology but also to appreciation of the vulnerability of pediatric subjects. Permission-assent or informed consent policies serve to protect pediatric subjects. Unfortunately, child-subject and parent-surrogate understanding of research is not satisfactory. Methods: The PubMed, Essential Evidence Plus, and CINAHL Plus databases were searched for literature on informed consent, permission, and assent in pediatric clinical trials. Articles with an emphasis on the parents' and subjects' understanding of clinical trials were selected for review and summary. Results: Seventy unique articles satisfied the search criteria. Each article was reviewed thoroughly for information about the informed consent process, parent (and, in some cases, child-subject) understanding of the nature of specific pediatric clinical trials, and procedures used or proposed to improve understanding of clinical research by subjects and/or their parents. Conclusion: Many parent-surrogates and child-subjects do not adequately understand clinical research. Parents and children often fail to understand randomization, especially as it relates to the principle of clinical equipoise. Children have additional difficulty with the nature of placebos and with right to withdraw from research at any time. Future research should prospectively evaluate interventions such as "staged consent," public education, medical trainee education, and alternative information-delivery methods, which are not yet known to consistently affect understanding.

Imerslund-Gräsbeck syndrome is an autosomal recessive disorder of vitamin B12 malabsorption presenting with megaloblastic anemia and mild proteinuria in childhood. The disorder is caused by biallelic pathogenic variants in the CUBN or AMN genes, which encode proteins involved in B12 absorption. We present the case of a 17-month-old boy with failure to thrive, pancytopenia, and fevers. His megaloblastic anemia was overlooked leading to unnecessary invasive testing. Findings on bone marrow biopsy prompted investigation for genetic disorders of B12 metabolism. Exome sequencing uncovered 1 known pathogenic variant and 1 novel likely pathogenic variant in CUBN, confirming the diagnosis of Imerslund-Gräsbeck syndrome.

Background Nearly all parents in the PICU experience traumatic stress. Separately, parent activation is a measure of knowledge, confidence, and willingness to engage in the management of a child’s health. We aimed to identify associations between parent activation, parent traumatic stress, the passage of time, and factors that may influence parent traumatic stress in the PICU. Methods This was a single-center, prospective study of parents with a child in the PICU. Data were obtained via two surveys, one within 48 hours of PICU admission and a second one month later. Results A sample of 101 parents of 74 patients completed the initial survey. Of these, 44 completed the follow-up. Parent activation and traumatic stress near PICU admission were associated with activation (r = 0.61, p < 0.001) and traumatic stress (r = 0.63, p < 0.001) one month later, respectively. On admission, parents with more preexisting depression and anxiety reported more traumatic stress (r = 0.36, p = 0.001 and r = 0.35, p = 0.004), and parents who reported more background life stressors also reported more traumatic stress (r = 0.29, p = 0.002). One month after admission, parents who thought having a written daily schedule for their child was or could be helpful reported less stress (0.34 vs. 1.05, p = 0.001), and the more helpful they found the schedule, the less stress they reported (r=-0.65, p = 0.003). The perceived helpfulness of a chaplain correlated with parent activation at admission (r = 0.3, p = 0.009) and follow-up (r = .48, p = 0.007), and parental use of a support website was associated with higher parent activation at admission (80 vs. 70, p = 0.010). Conclusions Parent activation and parent traumatic stress symptoms within 48 hours of PICU admission predict activation and traumatic stress at one-month follow-up. Parent traumatic stress is associated with parent depression, anxiety, and background life stressors. It is inversely associated with the recognition, use, and perceived helpfulness of parent supports. Parent activation is positively associated with the recognition, use, and perceived helpfulness of supports. These findings advance the theory that parent activation is a relevant concept in the framework of factors that influence parent traumatic stress in the PICU.