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Structure and Transparency in Translational Research (STRUCTURES)

转化研究的结构和透明度（结构）

基本信息

批准号：
260525081
负责人：
Professor Dr. Daniel Strech
金额：
--
依托单位：
Berlin Institute of Health (BIH)
依托单位国家：
德国
项目类别：
Research Grants
财政年份：
2014
资助国家：
德国
起止时间：
2013-12-31 至 2020-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/260525081?language=en
关键词：
Structure Transparency Translational Research STRUCTURES

项目摘要

The research project ¿Structure and Transparency in Translational Research (STRUCTURES)¿ focuses on normative and practical challenges in two intertwined tools for governing translational research: A) a more explicit and structured risk-benefit analysis in early human studies and B) a more comprehensive and standardized registration and reporting of preclinical animal research. This project integrates qualitative and quantitative socio-empirical research with relevant stakeholder, evaluation studies and normative analysis regarding the strength and weaknesses of the respective governance tools.To improve structure in the risk-benefit analysis in early human studies a stepwise, multidimensional tool (including a test template and user instruction) for planning and reviewing early human trials will be developed and applied in user test to evaluate construct validity and practical opportunities and challenges. Empirical and conceptual findings of the user test will inform the development of recommendations for future implementation research and policies regarding the structured risk-benefit analysis in early human studies.To improve the validity and usability of findings from preclinical animal research literature reviews and stakeholder interviews will be applied to identify the spectrum of normative and practical opportunities and challenges for the implementation of registries and reporting guidelines in animal research. First, attitudes of animal researchers towards study registration and reporting guidelines in animal research will be specified qualitatively and quantitatively. Based on the empirical findings and further normative analysis stakeholderspecific recommendations for the unbiased registration and reporting in animal research will be developed.The systematic and comprehensive identification of strengths and weaknesses together with the analysis of implementation barriers and normative challenges shall support an open and constructive discussion about how to develop and implement the two described governance tools in a way that improves the protection of research participants and the translation of research findings but also protects clinical and animal researchers against overregulation and plagiarism.

翻译研究中的结构和透明度(Structures)研究项目侧重于管理翻译研究的两个相互交织的工具中的规范和实践挑战：A)在早期人类研究中进行更明确和结构化的风险-效益分析，以及B)更全面和标准化的临床前动物研究登记和报告。该项目将定性和定量的社会实证研究与相关利益相关者、评估研究和关于各自治理工具的优缺点的规范分析相结合。为了改进早期人类研究中风险-收益分析的结构，将开发一个用于计划和审查早期人类试验的分步多维工具(包括测试模板和用户说明)，并将其应用于用户测试，以评估结构的有效性和实际机会和挑战。用户试验的经验性和概念性结果将为未来实施研究的建议和关于早期人类研究中结构化风险-效益分析的政策的制定提供信息。为了提高临床前动物研究结果的有效性和可用性，将应用文献综述和利益相关者访谈来确定在动物研究中实施登记和报告指南的规范性和实用性的机会和挑战的范围。首先，动物研究人员对动物研究中的研究登记和报告指南的态度将定性和定量地规定。基于实验结果和进一步的规范分析，将为动物研究中公正的登记和报告制定利益相关者特定的建议。系统和全面地识别优势和弱点，以及对实施障碍和规范挑战的分析，将支持就如何开发和实施上述两种治理工具进行公开和建设性的讨论，以改善对研究参与者的保护和研究结果的翻译，并保护临床和动物研究人员免受过度监管和抄袭。