The PREMIER project, funded by the Volkswagen Foundation, aims to develop a structured quality assurance system for preclinical academic biomedicine. From 2014-2017, we were probably the only academic research institution worldwide to maintain a certified quality management system according to DIN EN ISO 9001:2008. Our familiarity with the advantages and disadvantages of a highly structured but general quality management system and as a response to the existing replication crisis has led us to develop a QM system (PREMIER) that is tailored to academic research.
With PREMIER we propose to improve the quality of academic preclinical biomedicine through structured quality assurance measures. Existing approaches, norms and systems are resource-intensive and hardly suitable for preclinical biomedical research, especially in academia where additional regulatory elements are viewed as a threat to creativity, and therefore widely scorned by scientists. We have now developed a quality assurance system tailored to academic biomedicine consisting of "building blocks" of quality assurance measures that are modular, scalable, practical, affordable and acceptable to science.
Since it must be possible to monitor compliance with the standards, we have developed a new approach for verifying compliance with defined quality standards. New practicable options for auditing, such as "peer auditing", make it possible to assess compliance with standards. They also have the potential to improve the quality of preclinical research in the scientific community and support the daily work routine in the laboratory. PLOS ONE
Standards will be established in exchange of ideas with national and international scientists as well as with scientific organisations and sponsors, and complemented by meta-search.
PREMIER now offers scientists and research administrators the opportunity to pursue a more systematic and comprehensive approach to improving research quality in a modular way and with a low implementation threshold.
In addition to providing freely available tools, such as an anonymous error reporting system (LabCIRS), a research wiki and various templates (e.g. for SOPs, experimental design, etc.), we also support researchers with the consulting services of Responsible PrecliniX (RPX). RPX accompanies projects from the research question to publication and clinical implementation and offers a wide range of services within the research process.
Detailed information can be found on the PREMIER website.
The PREMIER model is a conceptual framework of modules with minimum requirements, which can adapt to the needs and resources of any organisation. PREMIER will use quality assurance and control of processes as well as tools to achieve and support reproducibility of the experimental results.
The PREMIER advisory board will lend us scientific support and external expertise for our purpose. They will give us advice and help us in all scientific issues during the project.
Six members who are experts in the fields of open science / open data and scientific research, as well as a scientific publisher, scientific sponsor and a member of the Volkswagenstiftung are part of the advisory board.