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

Anna Pohl^1*Elise Morel^2,3Eric A. J. Bleeker⁴Sean Kelly⁵Rachel Smith⁶Claus Svendsen²Thomas A. J. Kuhlbusch¹Elisabeth Heunisch¹

• ¹Federal Institute for Occupational Safety and Health, Dortmund, Germany
• ²UK Centre for Ecology and Hydrology (UKCEH), Wallingford, Oxfordshire, United Kingdom
• ³TEMAS Solutions GmbH, Hausen, Switzerland
• ⁴National Institute for Public Health and the Environment (Netherlands), Bilthoven, Utrecht, Netherlands
• ⁵Nanotechnology Industries Association, Brussels, Belgium
• ⁶UK Health Security Agency (UKHSA), London, United Kingdom

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 Organisation 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 towards standards and OECD Test Guidelines is key. Only then can their methods be expanded into a wider, regulatory application towards a safer world.