Guidance for Good In Vitro Reporting Standards (GIVReSt) - A draft for stakeholder discussion and background documentation.

Abstract

Reproducibility of cell culture experiments between laboratories needs to be improved by ensuring more complete reporting of methodology in scientific papers. The minimum reporting standards sug-gested here cover various cell culture methods including monolayers, stem cells, organoids, and microphysiological systems (MPS). The standards build on existing guidance like Good Cell Culture Practice (GCCP 2.0) and OECD test reporting guidelines on how to quality-assure in vitro work, focusing on transparency and completeness of reporting. Key elements to be reported include full details of cell source and identity, cell quality control and characterization, materials and reagents used, culture conditions and protocols, experimental design, data analysis, data availability, and legal and ethical aspects. For complex models, additional details need to be provided such as cell ratios, microenvironment conditions, functional characterization, etc. The guidance for Good In Vitro Reporting Standards (GIVReSt) is part of a broader initiative of evidence-based toxicology encompassing the improvement of the quality of in vitro studies for safety assessments and regulatory decisions. In summary, GIVReSt addresses incomplete reporting as a major factor affecting repro-ducibility of cell culture experiments by providing clear standards around transparency and rigor in reporting. The integration of agentic artificial intelligence (AI) is envisioned to streamline compliance checking, providing real-time feedback and accelerating scientific discovery by making high-quality evidence more accessible. This should lead to more reliable cell culture research overall.