In recent years, meta-research has exposed significant shortfalls in the planning, implementation, analysis and dissemination of results from biomedical research. The lack of reproducibility, even of findings that have been published in renowned magazines, has given rise to the term “replication crisis” and is probably at least partially responsible for the low success rate of transferring often spectacular findings in preclinical research to clinically effective treatments. There is broad consensus that the biomedical sciences, and particularly their preclinical domain, are affected by systematic quality issues. Striking in this context is the almost complete lack of structured quality control measures, which are standard in research in the pharmaceutical industry and clinical research, for example. We now propose to improve the quality of academic preclinical biomedicine with structured quality assurance measures. Unfortunately, existing approaches, standards and systems are only of limited suitability for preclinical biomedical research. They are resource-intensive and are regarded as a threat to creativity and therefore largely rejected by scientists.

We want to develop a quality assurance for academic biomedicine, consisting of ‘building blocks’ of quality assurance measures, which are modular, scalable, practical, affordable and acceptable for science. Compliance with the quality standards laid down therein should be made verifiable through new forms of peer auditing. The 'building blocks' of the system will be made freely available as e-resources in the form of tools and training modules. The project can draw on over 10 years of intensive discussions and practical experience in the Department of Experimental Neurology, including their DIN EN ISO-9001: 2008 certification. Our department boasts almost 100 employees, ranging from doctoral students to professors, implementing the full range of modern experimental biomedical approaches and techniques and can serve as a ‘laboratory’ for the practicability, relevance and acceptance of the developed quality standards and tools.

The aim is to show that a structured quality assurance is feasible and workable in preclinical biomedicine, is accepted by students and professionals and does not suppress creativity or lead to a ‘monitoring culture’. We also want to find evidence that this form of quality improvement can improve the robustness and value of research. We aspire to develop a ‘system’ that can be implemented in other working groups, departments or even institutions. These specific objectives are undoubtedly very ambitious in view of the scope of the work. We nevertheless believe that we will succeed in furthering the international efforts to improve the quality of preclinical academic biomedicine by proving the practicability of a research-oriented quality management and sparking an interest in the further improvement and dissemination of this kind of ‘open’ system for academic quality management.

Sponsored by the Volkswagen Foundation (2018-2021)