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This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. Furthermore, these studies did not consider children's understanding in the context of the disclosure process. Woodward's cholera study showed that adults are capable of understanding large amounts of complex medical information.5Numerous other studies have shown, however, that this capacity is usually not realised in routine consent situations. It is hypothesised that routine assent situations similarly, neither facilitate understanding nor maximise voluntariness.The present pilot study was designed to measure the quality of assent to a non-therapeutic clinical trial. It was hoped that by examining understanding and experience amongst children participating in an actual medical study, some information could be gained about the strengths and weaknesses of current assent practices. Such descriptive information could be used to generate models for the assent process.We focused on the assent process amongst healthy children participating in a nontherapeutic study. It was hoped that by examining understanding in children who were not routinely exposed to the medical system, the effects of the assent process on understanding and the research experience could be better isolated. Furthermore, it could be argued that understanding of children's ability to assent is of particular importance for non-therapeutic research, where compromises to a child's autonomy are not balanced by potential direct health benefits.To date, the question of whether or not it is appropriate to subject children to blood sampling for the sake of research has been based on conceptual analysis. To our knowledge this is the first time that the assent process has been examined in healthy children volunteering to provide a blood sample for research. MethodsThe design of this study was a cross-sectional survey. The instrument was a semi-structured interview, administered by the author.

Cardiac experimental electrophysiology is in need of a well-defined Minimum Information Standard for recording, annotating, and reporting experimental data. As a step toward establishing this, we present a draft standard, called Minimum Information about a Cardiac Electrophysiology Experiment (MICEE). The ultimate goal is to develop a useful tool for cardiac electrophysiologists which facilitates and improves dissemination of the minimum information necessary for reproduction of cardiac electrophysiology research, allowing for easier comparison and utilisation of findings by others. It is hoped that this will enhance the integration of individual results into experimental, computational, and conceptual models. In its present form, this draft is intended for assessment and development by the research community. We invite the reader to join this effort, and, if deemed productive, implement the Minimum Information about a Cardiac Electrophysiology Experiment standard in their own work.

ABSTRACT. Background and Objectives. Anecdotal reports on the efficacy of secretin in autism raised great hopes for the treatment of children with this disorder. Initial single-dose, randomized, controlled trials failed to demonstrate any therapeutic effects of secretin. The present study is the first to test the outcome of repeated doses and to examine whether there is a subgroup of children who are more likely to achieve positive effects.Method. Sixty-four children with autism (ages 2-7 years; 55 boys and 9 girls) with a range of intelligence quotient and verbal ability were randomly assigned, in a double-blind manner, to secretin or placebo groups. Children received 2 doses of placebo or porcine secretin, 6 weeks apart. Assessments were performed at baseline and 3 weeks after each injection using several outcome measures.Results. There were no group differences on formal measures of language, cognition, or autistic symptomatology. Subgroupings based on cognitive level, the presence or absence of diarrhea, or a history of regression failed to show any significant therapeutic effects of secretin.Conclusion. No evidence is provided for the efficacy of repeated doses of porcine secretin in the treatment of children with autism. The possible relationship between relief of biological symptoms and enhanced skill performance is discussed. Pediatrics 2001;107(5). URL: http://www.pediatrics.org/cgi/content/full/107/5/ e71; autism, secretin, language, behavior, cognitive functioning, gastrointestinal abnormalities.ABBREVIATIONS. GI, gastrointestinal; HSC, Hospital for Sick Children; ADI-R, Autism Diagnostic Interview-Revised; ADOS-G, Autism Diagnostic Observation Scale-Generic; PLS-3, Preschool Language Scale, III; ABC, Autism Behavior Checklist; ANOVA, analysis of variance.A utism is a severe, life-long neurobiological disorder with high morbidity. The disorder affects virtually all areas of functioning, notably social, communicative, cognitive, and behavioral. Prevalence is estimated to be as high as 5/1000 for the full spectrum of autistic disorders 1 and prognosis is generally poor. 2,3 To date, the cause of autism remains unknown, and there is no specific medical treatment. Psychopharmacological management continues to be far from satisfactory, with no pharmacologic agent having been shown to alter the natural history of the disorder.Against this background, recent clinical reports of a positive response to secretin in children with autism have generated widespread interest in and demand for this hormone. In 1998, Horvath et al 4 reported an uncontrolled case series of 3 autistic children who showed marked improvements in their social and language skills after administration of secretin for an investigative gastrointestinal (GI) procedure. This report received considerable media attention and escalating claims of a potential cure for autism resulted in likely thousands of children with autism being given secretin injections.Recently published placebo-controlled trials 5-7 failed to show any effect of secretin on co...

High-performance liquid chromatography separation of reduced and oxidized glutathione (GSH and GSSG) in biologic samples using electrochemical detection offers the convenience of both simultaneous quantitation and simple sample preparation. Rapid acidification is required to prevent GSH autooxidation, GSH and GSSG degradation, and precipitate proteins that interfere with analysis. Currently, little consistency exists in the literature regarding acid selection or the feasibility of sample storage before analysis. The purpose of this work was to examine the effects of perchloric (PCA), trichloroacetic (TCA), metaphosphoric (MPA), and 5-sulfosalicylic (SSA) acids on the short-term stability of GSH and GSSG measurements in whole blood. Samples were collected from adult volunteers and treated with multiple concentrations of each acid. The samples were analyzed immediately and aliquots were stored at -80 degrees C for up to 28 days. The suitability of each acid was assessed by percentage change of GSH and GSSG from baseline, efficiency of protein removal, and alteration of chromatogram characteristics. In general, increasing the acid concentration improved sample stability. Nevertheless, SSA did not achieve acceptable sample stability at any concentration tested. MPA was found to leave substantial amounts of protein in the samples, and TCA may interfere with the peaks of interest. Based on these results, a final concentration of 15% PCA is suggested for analysis of glutathione in whole blood. Although immediate sample preparation is preferred, 15% PCA can maintain sample integrity for 4 weeks after storage at -80 degrees C.