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
Citation:
Kraft, A., L. Dishaw, A. Luke, J. Waspe, T. Bui, AND A. Beronius. 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. Elsevier B.V., Amsterdam, Netherlands, 146:106103, (2021). https://doi.org/10.1016/j.envint.2020.106103
Impact/Purpose:
This manuscript reviews a tool for evaluating individual animal toxicology studies in the context of conducting systematic reviews of environmental chemicals, including comparisons to other available tools. Such tools allow for a consistent, transparent, and rigorous consideration of the validity and reliability of studies considered for use in hazard identification and dose-response analysis. Thus, review and refinement of approaches for evaluating individual studies can strengthen the first steps of the risk assessment process for environmental chemicals of potential concern to human health.
Description:
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.
URLs/Downloads:
DOI: 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