Qualichem in vivo: a tool for assessing the quality of in vivo studies and its application for bisphenol A

• Published in: PloS one Vol. 9; no. 1; p. e87738
• Main Authors: Maxim, Laura, van der Sluijs, Jeroen P
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 29-01-2014; Public Library of Science (PLoS)
• Subjects: Benzhydryl Compounds - toxicity; Biocompatibility; Biomedical research; Bisphenol A; Chemical industry; Chemicals; Clinical trials; Committees; Decision making; Endocrine Disruptors - toxicity; Environmental Sciences; Evaluation Studies as Topic; Food; Graphical representations; Guidelines; Health aspects; Health risks; Humans; In vivo methods and tests; Laboratory animals; Medicine; Neurotoxicity; Peer Review - methods; Phenols; Phenols (Class of compounds); Phenols - toxicity; Principles; Public health; Quality; Quality assessment; Quality control; Risk Assessment; Safety; Science; Science Policy; Social and Behavioral Sciences; Software; Studies; Toxicology; Transparency
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0087738

In regulatory toxicology, quality assessment of in vivo studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called "Qualichem in vivo" that is designed to systematically and transparently assess the quality of in vivo studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views-an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of in vivo studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines.