International Regulatory Transparency
ITSSD IQA SCOTUS Brief & Peer Review Expertise
Abstract: The role of experts in society, from ancient philosophers to contemporary scientific advisors has been debated since antiquity. The founder of the EPA, William Ruckelshaus, argued that the role of scientists in society is to address only scientific issues. This paper provides the seven principles that are the foundation of Ruckelshaus Effect. It also describes direct and indirect consequences of Ruckelshaus Effect including the Evolution of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived from it that are based on five principles (open-mindedness, skepticism, universal scientific principles, transparency, and reproducibility) and include three pillars (reliability standardization of science in terms of its maturity, and areas outside the purview of science). This paper also addresses the relationship between the Ruckelshaus Effect, risk analysis (assessment, management and communication), and the evolution of regulatory science as a new scientific discipline.
Summary: This handbooks guides the reader through all of the important aspects of peer review and explains how they are applied in the design and operation of successful review and assessment programs. Key topics include the selection of reviewers, identifying and mitigating conflicts of interest, and developing review criteria. The more general question of how scientific claims can be evaluated and controversies resolved is also considered in an exploration of the Best Available Science concept.
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