Setting off on the right path: make your research regulatory relevant
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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Research Metrics and Analytics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/frma.2025.1561964/full |
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| author | Anna Pohl Elise Morel Elise Morel Eric A. J. Bleeker Sean Kelly Rachel Smith Claus Svendsen Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Elisabeth Heunisch |
| author_facet | Anna Pohl Elise Morel Elise Morel Eric A. J. Bleeker Sean Kelly Rachel Smith Claus Svendsen Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Elisabeth Heunisch |
| author_sort | Anna Pohl |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-bde91d81aac44891b592f7a7f5ca24ea |
| institution | Kabale University |
| issn | 2504-0537 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Research Metrics and Analytics |
| spelling | doaj-art-bde91d81aac44891b592f7a7f5ca24ea2025-08-20T03:45:14ZengFrontiers Media S.A.Frontiers in Research Metrics and Analytics2504-05372025-06-011010.3389/frma.2025.15619641561964Setting off on the right path: make your research regulatory relevantAnna Pohl0Elise Morel1Elise Morel2Eric A. J. Bleeker3Sean Kelly4Rachel Smith5Claus Svendsen6Thomas A. J. Kuhlbusch7Thomas A. J. Kuhlbusch8Thomas A. J. Kuhlbusch9Elisabeth Heunisch10Hazardous Substances and Biological Agents, Federal Institute for Occupational Safety and Health (BAuA), Berlin/Dortmund, GermanyUK Centre for Ecology and Hydrology (UKCEH), Wallingford, United KingdomTEMAS Solutions GmbH, Hausen, SwitzerlandCentre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), Bilthoven, NetherlandsNanotechnology Industries Association Aisbl (NIA), Brussels, BelgiumUK Health Security Agency (UKHSA), Didcot, United KingdomUK Centre for Ecology and Hydrology (UKCEH), Wallingford, United KingdomHazardous Substances and Biological Agents, Federal Institute for Occupational Safety and Health (BAuA), Berlin/Dortmund, GermanyNano Particle Process Technology (NPPT), University Duisburg-Essen, Essen, GermanyCenter for Nanointegration Duisburg-Essen (CENIDE), University Duisburg-Essen, Essen, GermanyHazardous Substances and Biological Agents, Federal Institute for Occupational Safety and Health (BAuA), Berlin/Dortmund, GermanyScientifically 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.https://www.frontiersin.org/articles/10.3389/frma.2025.1561964/fullregulatory safety testingOECD test guidelinesmethod developmentmethod validationstandardization |
| spellingShingle | Anna Pohl Elise Morel Elise Morel Eric A. J. Bleeker Sean Kelly Rachel Smith Claus Svendsen Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Thomas A. J. Kuhlbusch Elisabeth Heunisch Setting off on the right path: make your research regulatory relevant Frontiers in Research Metrics and Analytics regulatory safety testing OECD test guidelines method development method validation standardization |
| title | Setting off on the right path: make your research regulatory relevant |
| title_full | Setting off on the right path: make your research regulatory relevant |
| title_fullStr | Setting off on the right path: make your research regulatory relevant |
| title_full_unstemmed | Setting off on the right path: make your research regulatory relevant |
| title_short | Setting off on the right path: make your research regulatory relevant |
| title_sort | setting off on the right path make your research regulatory relevant |
| topic | regulatory safety testing OECD test guidelines method development method validation standardization |
| url | https://www.frontiersin.org/articles/10.3389/frma.2025.1561964/full |
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