Kennedy Stephanie B, Heintz Melissa M, Klaren William D, Wikoff Daniele S, Haws Laurie C, Fitch Seneca E
ToxStrategies, LLC, Asheville, NC, United States.
ToxStrategies, LLC, Austin, TX, United States.
Environ Toxicol Chem. 2025 Apr 1;44(4):1142-1153. doi: 10.1093/etojnl/vgaf030.
A key component of ecological risk assessments is to develop evidence-based benchmarks to assess potential hazards to various receptors. To ensure that toxicity value development is performed using the best available science, the reliability (or inherent scientific quality) of these studies must be considered. The degree of reliability can be evaluated via critical appraisal tools (CATs), although application of such methods assessing ecotoxicological literature for toxicity value development is not well established compared with human health assessments. A review of existing CATs revealed that there is currently no approach that considers the full range of biases that should be considered for appraisal of internal validity in ecotoxicological studies. Recognizing the need for a comprehensive ecotoxicity study assessment framework that addresses RoB for the interpretation of study reliability, we propose the ecotoxicological study reliability (EcoSR) framework. This framework builds on the classic RoB assessment approach, frequently applied in human health assessments. The EcoSR framewok adds reliability and key criteria specific to ecotoxicity studies from existing appraisal methods, emphasizing those used by regulatory bodies. Additionally, the framework recommends a priori customization based on assessment goals. The EcoSR framework is composed of two tiers: an optional preliminary screening (Tier 1) and a full reliability assessment (Tier 2). The framework outlines a systematic approach for conducting ecotoxicity study appraisals that enhances transparency and consistency in determining study reliability. The EcoSR framework provides flexibility and can be refined and applied to a variety of chemical classes. This framework represents a significant step towards improving the transparency and reproducibility of ecotoxicological study appraisals; ultimately, contributing to more informed and reliable toxicity value development within the ecological sciences.
生态风险评估的一个关键组成部分是制定基于证据的基准，以评估对各种受体的潜在危害。为确保毒性值的制定采用现有最佳科学依据，必须考虑这些研究的可靠性（或内在科学质量）。虽然与人类健康评估相比，用于评估生态毒理学文献以制定毒性值的此类方法的应用尚未得到充分确立，但可靠性程度可通过关键评估工具（CATs）进行评估。对现有CATs的审查表明，目前尚无一种方法能考虑到生态毒理学研究内部有效性评估应考虑的所有偏差。认识到需要一个全面的生态毒性研究评估框架来解决研究可靠性解释中的偏倚风险（RoB），我们提出了生态毒理学研究可靠性（EcoSR）框架。该框架基于经典的RoB评估方法构建，这种方法常用于人类健康评估。EcoSR框架从现有评估方法中增加了生态毒性研究特有的可靠性和关键标准，强调监管机构使用的标准。此外，该框架建议根据评估目标进行预先定制。EcoSR框架由两层组成：一个可选的初步筛选（第1层）和全面的可靠性评估（第2层）。该框架概述了一种进行生态毒性研究评估的系统方法，可提高确定研究可靠性时的透明度和一致性。EcoSR框架具有灵活性，可进行完善并应用于各种化学类别。该框架是朝着提高生态毒理学研究评估的透明度和可重复性迈出的重要一步；最终，有助于在生态科学领域开展更明智、更可靠的毒性值制定工作。
