Scientific methods and findings are often not directly suitable for regulation unless they are appropriately prepared and standardized. However, researchers often consider this process to be too complex or time-consuming. A recent review article from members of the EU project NanoHarmony addresses this dilemma. The article identifies several reasons for the lack of transfer of scientific methods and protocols into standards or testing guidelines. First, many scientific methods are not sufficiently validated to ensure that they deliver reliable and reusable results. This is particularly important for regulation, as regulatory decisions must be based on solid and reproducible data. Furthermore, scientific methods are often not sufficiently documented to be understood and reproduced by other researchers or regulatory authorities. Good documentation is crucial for the standardization and application of methods. Another hurdle is the lack of interoperability. This means that methods must be developed in such a way that they are compatible with other methods and systems. This enables seamless integration into existing protocols and standards. However, this requires a deep understanding of the specific regulatory processes and requirements.
To overcome these hurdles, close cooperation between scientists and regulatory authorities is necessary. Scientists can improve their methods through targeted training and support in standardization and validation. Regulatory authorities, for their part, can better understand scientific methods and incorporate them into their work.
Conclusion: Scientific methods must be carefully prepared and standardized in order to be suitable for regulation. This requires close cooperation and joint efforts between scientists and regulatory authorities.
The review article offers important guidance on this topic: Pohl A, Morel E, Bleeker EAJ, Kelly S, Smith R, Svendsen C, Kuhlbusch TAJ and Heunisch E (2025) Setting off on the right path: make your research regulatory relevant. Front. Res. Metr. Anal. 10:1561964.
