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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process
Published 2025-02-01“…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.MethodsAn open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.ResultsA 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. …”
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Institutional community engagement leader perspectives on supporting ethical community-engaged research
Published 2025-01-01“…Methods: As part of a larger interview study aiming to learn more about how institutional CE programs and HRPPs work together, we analyzed interviews with CE program leaders at academic medical centers that receive funding from the NIH CTSA program to identify barriers and strategies to conducting CEnR at their institutions, primarily focusing on the relationships with Institutional Review Boards (IRBs). Results: We identified three categories in the interviews: barriers and strategies vis-à-vis IRBs to address 1) CE/IRB relationships; 2) Understanding issues; and 3) Structural and resource issues. …”
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Relevance of tumor boards for the inclusion of patients in oncological clinical trials
Published 2023-03-01“…Abstract Introduction Major national and international oncological societies generally recommend treating a significant proportion of oncological patients in clinical trials to improve therapy strategies for cancer patients. …”
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Understanding Tobacco Control: Global and National Strategies
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EFFECT OF BOARD STRUCTURE ON CORPORATE SOCIAL AND ENVIRONMENTAL SUSTAINABILITY PERFORMANCE OF LISTED NIGERIAN OIL AND GAS FIRMS
Published 2024-01-01“… Empirical review has established a paucity of research around board structure and sustainability performance, especially in Nigeria. …”
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Variation in Assessing Renal Allograft Rejection: A National Assessment of Nephrology Practice
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Tracking Progress of National Health Summit Declarations - Health Policy Analysis: A Qualitative Study
Published 2024-12-01“…Ethical approval from Nepal Health Research Council, Ethical Review Board (Reference number: 1069). The study was designed using the Realistic Evaluation Framework to look into the “context” which are the external factors impacting implementation of the declarations, the “mechanism” which are key elements facilitating or hindering policy changes, and the “outcome” which were the tangible results of NHS declarations. …”
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INTEGRATION OF EDUCATION, SCIENCE, AND BUSINESS: CURRENT INSTITUTIONAL SOLUTIONS
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Enhancing Biomedical Research Through Strategic Funding: A Comprehensive Review
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Effectiveness of School Dental Health Programs: A Review with Insights from India
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An integrated corporate governance index for Spain: From construction to construct validity
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Review and Improvement of Runway Friction and Aircraft Skid Resistance Regulation, Assessment and Management
Published 2025-01-01“…Despite being internationally regulated, investigation reports published by the Australian Transport Safety Bureau and the US National Transportation Safety Board indicate that 4.9–22% of runway excursion accidents are related to insufficient friction, or to friction overestimation. …”
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Creation of a nationwide breastfeeding policy for surgical residents: a scoping review protocol
Published 2022-06-01“…The aim of this scoping review is to assess existing breastfeeding policies for surgical trainees at the national level including postgraduate medical education offices, provincial resident unions and individual surgical programmes.Methods and analysis A modified Arksey and O’Malley (2005) framework will be used. …”
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Integration of planetary health in undergraduate and postgraduate medical education: protocol for a scoping review
Published 2022-06-01“…Outcomes will be categorised within the domains of the Planetary Health Education Framework, which incorporates concepts of systems thinking, social justice and interconnection within nature as they apply to education for planetary health.Ethics and dissemination As no intervention or patient recruitment will be required, research ethics board approval is not applicable. We plan to disseminate our results via publication in a peer-reviewed journal or conference presentation.Trial registration number This protocol has been registered in Open Science Framework (10.17605/OSF.IO/7M6GZ).…”
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The impact of trauma and how to intervene: a narrative review of psychotraumatology over the past 15 years
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Ten Years of the Global Reform of Financial Regulation: What is ahead?
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