Structure and Transparency in Translational Research (STRUCTURES)

研究项目“转化研究的结构和透明度”（STRUCTURES）侧重于管理转化研究的两个相互交织的工具中的规范和实践挑战：A)早期人类研究中更明确和结构化的风险-收益分析；B)临床前动物研究的更全面和标准化的注册和报告。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。为了改进早期人体研究风险-收益分析的结构，将开发一种用于规划和审查早期人体试验的逐步、多维的工具（包括测试模板和用户说明），并将其应用于用户测试中，以评估结构的有效性和实践机遇与挑战。用户测试的经验和概念发现将为未来实施研究的建议和早期人体研究中结构化风险-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和实践机会和挑战。首先，将定性和定量地说明动物研究人员对动物研究注册和报告指南的态度。根据实证研究结果和进一步的规范分析，将制定有关动物研究中公正注册和报告的利益相关者具体建议。系统和全面地识别优势和劣势，以及对实施障碍和规范挑战的分析，将支持关于如何开发和实施所描述的两种治理工具的公开和建设性讨论，以改善对研究参与者的保护和研究成果的翻译，同时也保护临床和动物研究人员免受过度监管和抄袭。

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.