The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

BACKGROUND/AIMS: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. METHODS: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. RESULTS: While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. CONCLUSION: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health's goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

The NICHD Investigative Interview Protocol: A Meta-Analytic Review.

Systematic review and meta-analysis of literature were conducted examining the effectiveness of the National Institute for Child Health and Human Development Investigative Interview Protocol in improving the quality of child forensic interviews. Online databases were searched for journal articles published between the years 2000 and 2013. Measures of interview quality were the type of interviewer utterances and the amount of information provided by children. Five studies met criteria for inclusion in the meta-analysis. Weighted mean of the effect sizes was calculated for each outcome measure. Protocol interviews had more invitations (g = 1.60) and fewer option-posing (g = -.95) and suggestive prompts (g = -.63) than standard interviews. Children interviewed by the protocol provided more central details (g = .90) in response to invitations than controls. Meta-analyses of a subset of preschool children samples revealed that protocol interviews had more invitations (g = 1.46), fewer suggestive prompts (g = -.61), and fewer option-posing prompts (g = -1.05) than controls. Findings corroborate results from previous studies that suggested the benefits of the protocol on the interviewers' performance and on children's informativeness. However, protocol did not show the same performance with regard to preschool children.

A call for field-relevant research about child forensic interviewing for child protection.

This article reviews some sensitivity versus specificity imbalances in forensic investigations of child sexual abuse. It then proposes the development or further testing of additional approaches for those children who do not respond to the current, single-interview National Institute of Child Health and Human Development (NICHD) protocol. Although there are other interview protocols based on similar principles, the NICHD protocol has the strongest evidence base in both field and laboratory studies to elicit detailed and accurate information from children. Adaptations of the NICHD protocol or additional approaches need to be developed and tested for nondisclosing, partially disclosing, or recanting children, very young children, children with developmental disabilities, and children whose sexual abuse allegations are evaluated in the context of custody or visitation disputes.

Clinical seizures in neonatal hypoxic-ischemic encephalopathy have no independent impact on neurodevelopmental outcome: secondary analyses of data from the neonatal research network hypothermia trial.

It remains controversial as to whether neonatal seizures have additional direct effects on the developing brain separate from the severity of the underlying encephalopathy. Using data collected from infants diagnosed with hypoxic-ischemic encephalopathy, and who were enrolled in an National Institute of Child Health and Human Development trial of hypothermia, we analyzed associations between neonatal clinical seizures and outcomes at 18 months of age. Of the 208 infants enrolled, 102 received whole body hypothermia and 106 were controls. Clinical seizures were generally noted during the first 4 days of life and rarely afterward. When adjustment was made for study treatment and severity of encephalopathy, seizures were not associated with death, or moderate or severe disability, or lower Bayley Mental Development Index scores at 18 months of life. Among infants diagnosed with hypoxic-ischemic encephalopathy, the mortality and morbidity often attributed to neonatal seizures can be better explained by the underlying severity of encephalopathy.