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Pediatric Research (pediatric + research)

Distribution by Scientific Domains
Medical Sciences75%

Selected Abstracts

Incidental Findings in Pediatric Research

THE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 2 2008
Benjamin S. Wilfond
The approach to incidental research fndings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental fndings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information (e.g., pregnancy or drug use) should be disclosed to the adolescent frst, while particularly serious information (e.g., cancer) should frst be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where there may be presumptive expectations of confdentiality about sharing information within the family, in most research settings it is reasonable to plan to disclose such information to both parties. It is important to communicate this plan during the informed consent process separately to adolescents to avoid enrolling adolescents when sensitive incidental fndings such as pregnancy and drug use may be detected. The approach to incidental fndings without clear and proximate beneft is challenging. Researchers should plan more limited disclosure of such incidental fndings for pediatric participants than for adult participants. [source]

Ethical Considerations for a Child's Participation in Research

JOURNAL FOR SPECIALISTS IN PEDIATRIC NURSING, Issue 1 2004
Sheri Kanner MSN
ISSUES AND PURPOSE To analyze ethical considerations for a child's involvement in research. CONCLUSIONS Pediatric research can proceed only when the welfare of children is protected. Although research with children as research subjects constitutes only a small portion of research efforts, its continual growth requires nurses be aware of the rights of pediatric subjects. PRACTICE IMPLICATIONS As nursing research increases in sophistication, the nurse should include an assessment of the informed consent process in the care of the patient, including the child's comprehension, the age and development of the child, and the child's perception of the research. [source]

Talairach-Based Parcellation of Neonatal Brain Magnetic Resonance Imaging Data: Validation of a New Approach

JOURNAL OF NEUROIMAGING, Issue 4 2005
Haissam Haidar PhD
ABSTRACT Background and Purpose. Talairach-based parcellation (TP) of human brain magnetic resonance imaging (MRI) data has been used increasingly in clinical research to make regional measurements of brain structures in vivo. Recently, TP has been applied to pediatric research to elucidate the changes in regional brain volumes related to several neurological disorders. However, all freely available tools have been designed to parcellate adult brain MRI data. Parcellation of neonatal MRI data is very challenging owing to the lack of strong signal contrast, variability in signal intensity within tissues, and the small size and thus difficulty in identifying small structures used as landmarks for TP. Hence the authors designed and validated a new interactive tool to parcellate brain MRI data from newborns and young infants. Methods. The authors' tool was developed as part of a postprocessing pipeline, which includes registration of multichannel MR images, segmentation, and parcellation of the segmented data. The tool employs user-friendly interactive software to visualize and assign the anatomic landmarks required for parcellation, after which the planes and parcels are generated automatically by the algorithm. The authors then performed 3 sets of validation experiments to test the precision and reliability of their tool. Results. Validation experiments of intra-and interrater reliability on data obtained from newborn and 1-year-old children showed a very high sensitivity of >95% and specificity >99.9%. The authors also showed that rotating and reformatting the original MRI data results in a statistically significant difference in parcel volumes, demonstrating the importance of using a tool such as theirs that does not require realignment of the data prior to parcellation. Conclusions. To the authors' knowledge, the presented approach is the first TP method that has been developed and validated specifically for neonatal brain MRI data. Their approach would also be valuable for the analysis of brain MRI data from older children and adults. [source]

U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary

ACADEMIC EMERGENCY MEDICINE, Issue 1 2008
Andrew McRae MD
Abstract Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. [source]