WPHA project on OECD Harmonised Templates (OHTs) for reporting non-guideline research data
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Research data is defined as any specific data generated in a research context, but outside of nationally or internationally recognized standards (e.g. OECD Guidelines for the Testing of Chemicals) that could potentially inform hazard, exposure, and/or risk assessments of chemicals. Further, research data includes information obtained from human and environmental observational studies as well as experimental methods (e.g., in vivo, in vitro, ‘omics) and computational (in silico) methods, and new approach methodologies (NAMs) intended to advance scientific knowledge rather than provide data for a specific hazard or assessment question. Research data adds to the scientific evidence base in regulatory assessment, often covering information not typically covered by regulatory testing frameworks, but for the purpose of advancing scientific knowledge rather than informing a particular hazard or assessment question. Test guideline data is made publicly available via standardized reporting frameworks (e.g., OECD Harmonized Templates (OHTs) whereas scientific journals serve as the primary avenue for publishing research data. A regulatory context differs significantly in how study reliability (how the study was designed, performed, and analyzed) and relevance (potential impact) are evaluated compared with a journal-led peer review model. The result is inconsistent reporting of research data due to lack of harmonized guidance and reporting standards, affecting overall data quality and even the exclusion of many research studies from regulatory assessments because core details in the method and/or results are not reported.
Therefore, the OECD recently developed Guidance on the generation, reporting, and use of research data (draft, anticipated release fall 2025) which outlines fundamental principles of research data quality, includes concepts of reliability and relevance, and describes core considerations foundational to the assessment of data quality in a regulatory context. The Guidance targets all stakeholder groups (funders, researchers, editors, publishers, peer reviewers, assessors, and risk managers) involved in the research data life cycle (from data production to regulatory uptake) and addresses specifically regulatory data requirements. Recognizing that there is no current standardized reporting template for research data, the OECD is implementing a new type of OECD Harmonized template for Research data (OHTR) that is an implementation of the Guidance document. The OHTR aims to standardize and simplify data reporting requirements for research data to improve regulatory uptake. In this presentation a progress update on the OHTR project will be given at the 9th meeting of the Working Party on Hazard Assessment.