Setting off on the right path: make your research regulatory relevant

Pohl, Anna; Morel, Elise; Bleeker, Eric A.J.; Kelly, Sean; Smith, Rachel; Svendsen, Claus ORCID: https://orcid.org/0000-0001-7281-647X; Kuhlbusch, Thomas A.J.; Heunisch, Elisabeth. 2025 Setting off on the right path: make your research regulatory relevant. Frontiers in Research Metrics and Analytics, 10, 1561964. 12, pp. 10.3389/frma.2025.1561964

Before downloading, please read NORA policies.

Preview

Text N539654JA.pdf - Published Version Available under License Creative Commons Attribution 4.0. Download (2MB) | Preview

Abstract/Summary

Scientifically well-established methods do not automatically get used in regulations. Even when there is an urgent need for regulatory relevant test methods, methods need to pass through a so-called standardization process. This involves following specific agreed processes, which define the timeline and requirements (e.g., validation, documentation, approval) before the method can be integrated in regulatory oriented standards or Test Guidelines from the Organization of Economic Cooperation and Development (OECD). The process is often seen as too complex or too resource (and time) consuming by the scientific community, which inhibits method developers from translating their scientific methods and protocols into standards or OECD Test Guidelines. Numerous incentives exist for scientists to be (more) active in the standardization process and allow regulation to keep up with new scientific developments. These include an increase in research impacts, an expansion and diversification of the international expert network, and an access to more fundings. This paper shows scientists how to reach such outcomes, by providing guidance on how to navigate successfully through the standards and OECD Test Guidelines development processes. Especially the requirements for method validation, which is a prerequisite in this process and common across the different standardization bodies. For further details and insights, readers are invited to consult the various freely available resources generated by the NanoHarmony EU project. These are compiled in the OECD Test Guideline Process Mentor ( https://testguideline-development.org/ ). The active participation of scientists along the entire process toward standards and OECD Test Guidelines is key. Only then can their methods be expanded into a wider, regulatory application toward a safer world.

Item Type:	Publication - Article
Digital Object Identifier (DOI):	10.3389/frma.2025.1561964
UKCEH and CEH Sections/Science Areas:	National Capability and Digital Research (2025-) Unaffiliated
ISSN:	2504-0537
Additional Information:	Open Access paper - full text available via Official URL link.
Additional Keywords:	regulatory safety testing, OECD test guidelines, method development, method validation, standardization
NORA Subject Terms:	Law Data and Information
Date made live:	20 Jun 2025 11:56 +0 (UTC)
URI:	https://nora.nerc.ac.uk/id/eprint/539654

Actions (login required)

View Item

Document Downloads

More statistics for this item...