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Evaluating reliability and risk of bias of in vivo animal data for risk assessment of chemicals – Exploring the use of the SciRAP tool in a systematic review context
Environment International ( IF 10.3 ) Pub Date : 2020-10-22 , DOI: 10.1016/j.envint.2020.106103
Jennifer Waspe 1 , Thuy Bui 2 , Laura Dishaw 3 , Andrew Kraft 3 , April Luke 3 , Anna Beronius 1
Affiliation  

Within the field of health risk assessment, it is essential that evaluations of reliability or validity of toxicity data are conducted with structure and transparency. To this end, different tools for evaluating toxicity studies have been developed by different groups and organizations, for different specific purposes. The Science in Risk Assessment and Policy (SciRAP) tool was developed for use in the regulatory health risk assessment of chemicals and to promote structured and transparent evaluation of study reliability within European regulatory frameworks. As such, the SciRAP tool is not specifically tailored for use in a systematic review context. However, in light of the current movement towards applying systematic review in the field of environmental health and chemical assessments and European chemicals regulation, we were interested in exploring how SciRAP could be applied in such a context. To achieve this, the scope of the SciRAP tool was first compared to two tools developed based on systematic review principles at the US Environmental Protection Agency’s IRIS program and the National Toxicology Program’s Office of Health Assessment and Translation (OHAT). Next, the SciRAP and IRIS tools were both applied in a case study to evaluate the same nine in vivo animal studies and the resulting evaluations were compared.

The SciRAP tool was found to address the majority of the elements included for study evaluation in the OHAT and IRIS tools. In the case study, no major differences were found in the conclusions drawn when using SciRAP or IRIS tools. However, future developments to bring the SciRAP tool more in line with systematic review principles were identified and are discussed.

Overall, this work illustrates the advantages of applying structured and pre-defined methods for study evaluation and provides a unique case study comparing the impact of using different tools for evaluating animal toxicity studies.



中文翻译:


评估化学品风险评估的体内动物数据的可靠性和偏倚风险 – 探索 SciRAP 工具在系统评价背景下的使用



在健康风险评估领域,以结构化和透明的方式对毒性数据的可靠性或有效性进行评估至关重要。为此,不同的团体和组织出于不同的具体目的开发了不同的毒性研究评估工具。风险评估和政策科学 (SciRAP) 工具的开发用于化学品的监管健康风险评估,并促进欧洲监管框架内对研究可靠性的结构化和透明评估。因此,SciRAP 工具并不是专门为系统评价环境中使用而定制的。然而,鉴于当前在环境健康和化学品评估以及欧洲化学品监管领域应用系统审查的趋势,我们有兴趣探索如何在这种背景下应用 SciRAP。为了实现这一目标,首先将 SciRAP 工具的范围与美国环境保护署 IRIS 计划和国家毒理学计划健康评估和翻译办公室 (OHAT) 的系统审查原则开发的两种工具进行了比较。接下来,SciRAP 和 IRIS 工具均应用于案例研究中,以评估相同的九项体内动物研究,并对所得评估结果进行比较。


我们发现 SciRAP 工具可以解决 OHAT 和 IRIS 工具中研究评估所包含的大部分要素。在案例研究中,使用 SciRAP 或 IRIS 工具得出的结论没有发现重大差异。然而,我们确定并讨论了使 SciRAP 工具更符合系统审查原则的未来发展。


总体而言,这项工作说明了应用结构化和预定义方法进行研究评估的优势,并提供了一个独特的案例研究,比较了使用不同工具评估动物毒性研究的影响。

更新日期:2020-10-30
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