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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process
No full textBackground: conducting clinical drug trials (CTs) with children presents several challenges. A major challenge is the need to enroll participants at multiple sites across different jurisdictions. Recruiting the required number of children within a reasonable timeframe requires the study to be reviewed by Research Ethics Boards (REB) or Institutional Review Boards (IRB) at multiple sites across various jurisdictions. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the research ethics review requirements including any pediatric specific requirements, as well as current or upcoming changes across six jurisdictions – the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia.Methods: an open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.Results: a synopsis of the current regulatory requirements covers centralized versus independent review, comparisons between investigator initiated and industry sponsored clinical trials, timelines, review board members requirements and the consenting/assent process for clinical trial (CT) applications, application submission processes and application requirements for each of the six jurisdictions. It also describes changes currently or soon to be implemented in some jurisdictions.Conclusion: this environmental scan highlights the differences in ethics review for CTs in pediatric medicine development across six jurisdictions. While there is a growing trend for centralized ethics review, it is not universally permitted due to institutional, state/provincial, or national policies. Even where central review is allowed, local review may still be required for vulnerable populations like children. Harmonized and centralized ethics reviews offer advantages such as expert pediatric reviewers and efficient and consistent evaluations
Sortition: past and present
No full textSince ancient times sortition (random selection by lot) has been used both to distribute political office and as a general prophylactic against factionalism and corruption in societies as diverse as classical-era Athens and the Most Serene Republic of Venice. Lotteries have also been employed for the allocation of scarce goods such as social housing and school places to eliminate bias and ensure just distribution, along with drawing lots in circumstances where unpopular tasks or tragic choices are involved (as some situations are beyond rational human decision-making). More recently, developments in public opinion polling using random sampling have led to the proliferation of citizens' assemblies selected by lot. Some activists have even proposed such bodies as an alternative to elected representatives. The Journal of Sortition benefits from an editorial board with a wide range of expertise and perspectives in this area. In this introduction to the first issue, we have invited our editors to explain why they are interested in sortition, and to outline the benefits (and pitfalls) of the recent explosion of interest in the topic
A vulnerability index for assessing coastal change impacts on Lebanese maritime archaeology
No full textInvestigating the sustainability of using wild-caught fish as feed in aquaculture through a systems approach
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An experimental study of machine-learning-driven temperature monitoring for Printed Circuit Boards (PCBs) using ultrasonic guided waves
No full textTemperature has a significant impact on the operational lifetime of electronic components, as excessive heat can lead to accelerated degradation and ultimately failure. In safety-critical applications, it is important that real-time monitoring is employed to reduce the risk of system failures and maintain the safety, reliability, and integrity of the connected systems. In the case of printed circuit boards (PCBs), it is often not feasible to install enough sensors to adequately cover all of the temperature sensitive components. In this study, we present a novel method for the temperature monitoring of PCBs using ultrasonic guided waves and machine learning techniques. Our approach utilizes a small number of low-cost, unobtrusive piezoelectric wafer active sensors (PWAS) sensors for propagating ultrasonic guided waves across a PCB. Through interaction with board features, the temperature of components can be predicted using multi-output regression algorithms. Our technique has been applied to three different PCBs, each with five hotspot positions, achieving an RMSE of <3.5 °C an
Lightweight and roubust key agreement for securing IIoT-driven flexible manufacturing systems
No full textThe ever-evolving Internet of Things (IoT) has ushered in a new era of intelligent manufacturing across multiple industries. However, the security and privacy of realtime data transmitted over the public channel of the industrial IoT (IIoT) remain formidable challenges. Existing lightweight protocols often omit one or more critical security features, such as anonymity and untraceability, and are susceptible to threats like desynchronization attacks. Additionally, they struggle to achieve an optimal balance between robust security and performance efficiency. To bridge these gaps, we introduce a new lightweight key agreement security scheme that guarantees secure access to the IIoT-enabled flexible manufacturing system (FMS). The strength of our scheme lies in its utilization of the authenticated encryption with associative data (AEAD) primitive, AEGIS, along with hash functions and physical unclonable functions, which secure the IIoT ecosystem. Additionally, our scheme offers flexibility in the form of the addition of new machines, password updates, and revocation in cases of theft or loss. A comprehensive security analysis demonstrates the efficacy of the proposed scheme in thwarting various attacks. The formal analysis, based on the Real-Or-Random (RoR) model, ensures session key indistinguishability, while the informal analysis highlights its resilience against known attacks. The comparative assessment demonstrate that the proposed scheme consistently outperforms the benchmark schemes across multiple dimensions, including security and functionality features, computational and communication overheads, and runtime efficiency. Specifically, the proposed scheme achieves peak performance enhancements of 77.55%, 44.73%, and 69.6% in computational overhead, runtime overhead, and communication overhead, respectively, underscoring its substantial performance advantages
Adult-child pedagogical interactions in the home and in preschool: what commonalities can pre-schoolers experience in the context of cognitive development?
No full textEarly Childhood Education and Care (ECEC) research emphasises the importance of adult-child pedagogical interactions at home and in ECEC settings for children’s cognitive development. Meanwhile, recent developments in statistics offer the opportunity to challenge gaps in ECEC knowledge fostered by traditional statistical methods.Aim: using contemporary statistical mixture modelling procedures: What commonalities exist across the home and preschool in the adult child pedagogical interactions that children can experience in the context of cognitive development?Methods: secondary analysis of data from the Effective Provision of Preschool Education study: 2,857 children and families using 141 ECEC settings across England. Results: commonalities are found that vary by pre-schoolers’ verbal and nonverbal reasoning. These commonalities reveal the importance of different home learning environments plus opportunities for more equitable and inclusive ECEC. Contemporary statistical methods can reveal new and important ways in which adult-child pedagogical interactions at home and in ECEC settings may shape children’s development
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