Structure and Transparency in Translational Research (STRUCTURES)

• Applicant: Professor Dr. Daniel Strech
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine ; Epidemiology and Medical Biometry/Statistics
• Term: from 2014 to 2021
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 260525081

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.

• DFG Programme: Research Grants