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

Frontiers in research metrics and analytics Pub Date : 2025-06-16 eCollection Date: 2025-01-01 DOI:10.3389/frma.2025.1561964
Anna Pohl, Elise Morel, Eric A J Bleeker, Sean Kelly, Rachel Smith, Claus Svendsen, Thomas A J Kuhlbusch, Elisabeth Heunisch
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引用次数: 0

Abstract

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.

走上正确的道路:让你的研究与监管相关。
科学上已经确立的方法不会自动用于法规中。即使迫切需要监管相关的测试方法,方法也需要通过所谓的标准化过程。这包括遵循特定的商定过程,在方法可以整合到经济合作与发展组织(OECD)的面向监管的标准或测试指南之前,该过程定义了时间表和要求(例如,验证、文件、批准)。这一过程通常被科学界视为过于复杂或过于耗费资源(和时间),这阻碍了方法开发者将他们的科学方法和协议转化为标准或OECD测试指南。存在着许多激励措施,促使科学家(更)积极地参与标准化进程,并允许监管跟上新的科学发展。这包括研究影响的增加、国际专家网络的扩大和多样化,以及获得更多的资助。这篇论文向科学家们展示了如何通过标准和经合组织测试指南的开发过程成功导航,从而达到这样的结果。特别是对方法验证的需求,这是该过程的先决条件,并且在不同的标准化组织中是通用的。要了解更多细节和见解,请读者查阅NanoHarmony EU项目生成的各种免费资源。这些都汇编在经合组织测试指南过程导师(https://testguideline-development.org/)。在制定标准和经合组织测试指南的整个过程中,科学家的积极参与是关键。只有这样,他们的方法才能扩展到更广泛的监管应用,以实现一个更安全的世界。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
3.50
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