Workshop Report: Evaluation of Epidemiological Data Consistency for Application in Regulatory Risk Assessment

Ronald H. White*, 1, Mary A. Fox2, Glinda S. Cooper3, Thomas F. Bateson3, Thomas A. Burke2, Jonathan M. Samet4
1 R.H. White Consultants, Silver Spring, MD, USA
2 Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD,USA
3 National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington DC, USA
4 Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA

© 2013White et al..

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: ( This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the R.H. White Consultants, LLC, 12900 Tourmaline Terrace, Silver Spring, MD, USA; Tel: (240) 381-4075; Fax: (301) 384-8876; E-mail:


Epidemiological study results have a key role in the assessment of health risks associated with exposures to chemicals and pollutants, and often serve as the basis for the development of regulatory limits for environmental and occupational health. A key uncertainty in the application of epidemiological study results in risk assessments stems from variability in defining and operationalizing the concept of consistency of findings across studies, with assessments of consistency often a controversial component of risk assessments. Although assessment of consistency of findings across a diverse collection of epidemiological studies is central to evaluating that body of evidence for supporting causal inferences, the variability in definition and formal evaluation methods strongly suggest the need for constructive approaches to consistently and transparently evaluate data consistency.

In response to the need to improve approaches to assessing consistency in epidemiological study results, the Johns Hopkins Risk Sciences and Public Policy Institute organized a workshop held in Baltimore, Maryland in September 2010 to identify and discuss key methodological issues, and to develop recommendations for qualitative and quantitative approaches to addressing those issues. A multi-disciplinary approach was utilized for the workshop, involving invited experts from a variety of fields, and the invited participants were drawn from academia, industry, government, and the public interest sectors. This report provides a summary of selected epidemiology methodological issues discussed by the workshop participants and provides the workshop’s key findings and recommendations for future approaches to addressing this issue.

Keywords: Consistency, epidemiology, heterogeneity, regulation, risk assessment, workshop report.