The need for standardisation in life science research - an approach to excellence and trust.

Abstract

Today, academic researchers benefit from the changes driven by digital technologies and the enormous growth of knowledge and data, on globalisation, enlargement of the scientific community, and the linkage between different scientific communities and the society. To fully benefit from this development, however, information needs to be shared openly and transparently. Digitalisation plays a major role here because it permeates all areas of business, science and society and is one of the key drivers for innovation and international cooperation. To address the resulting opportunities, the EU promotes the development and use of collaborative ways to produce and share knowledge and data as early as possible in the research process, but also to appropriately secure results with the European strategy for Open Science (OS). It is now widely recognised that making research results more accessible to all societal actors contributes to more effective and efficient science; it also serves as a boost for innovation in the public and private sectors. However for research data to be findable, accessible, interoperable and reusable the use of standards is essential. At the metadata level, considerable efforts in standardisation have already been made (e.g. Data Management Plan and FAIR Principle etc.), whereas in context with the raw data these fundamental efforts are still fragmented and in some cases completely missing. The CHARME consortium, funded by the European Cooperation in Science and Technology (COST) Agency, has identified needs and gaps in the field of standardisation in the life sciences and also discussed potential hurdles for implementation of standards in current practice. Here, the authors suggest four measures in response to current challenges to ensure a high quality of life science research data and their re-usability for research and innovation.

Quality Management Tools on the Stage: Old but New Allies for Rigor and Standardization of Extracellular Vesicle Studies

“…A QM System is defined as a formalized system that documents processes, procedures and responsibilities, to support the organization activities in meeting their own objectives, customer and regulatory requirements as well as improving their performance on a continuous basis ( Ziegel and Lamprecht, 1993 ; Hadjicostas, 2010 ; ISO, 2019 ). In the context of research institutes, a structured approach to QM has a great potential to improve the rigor, reproducibility, reliability and ultimately value and technological transfer potential of scientific research ( Bongiovanni et al, 2015 ; Lanati, 2018 ; Molinéro-Demilly et al, 2018 ; Gregory, 2020 ; Hewera et al, 2020 ; Liguori and Kisslinger, 2020 ; Lovrenčić Mikelić, 2020 ; Hollmann et al, 2021 ). In addition, the implementation of a QM approach may support the development and execution of research projects, especially in an interdisciplinary, multi-site and high-risk context, providing a roadmap toward improved harmonization and standardization of procedures as well as reliability of results ( Dehouck et al, 2019 ; Liguori and Kisslinger, 2020 ).…”