Improving the quality of risk assessments in Canada using a principle-based approach

Forristal, P.M.; Wilke, Dominik; McCarty, L.S.

doi:10.1016/j.yrtph.2008.01.013

Cited by 3 publications

(1 citation statement)

References 7 publications

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“…In Canada, the Framework for Science and Technology Advice (Government of Canada 2000) states clear government-mandated quality-based principles for conducting and evaluating both scientific information and decision-making processes used in regulations protecting human and environmental health. However, Forristal et al (2008) noted that specific operational frameworks are not fully available for applying these principles in generating chemical risk assessments.…”

Section: Discussionmentioning

confidence: 99%

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

McCarty¹,

Borgert

Mihaich³

2012

Environ Health Perspect

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Background: There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates.Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards.Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations.Discussion: Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data.Conclusions: Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

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Section: Discussionmentioning

confidence: 99%

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

McCarty¹,

Borgert

Mihaich³

2012

Environ Health Perspect

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Letter to the Editor in Response to Forristal et al.: Improving the Quality of Risk Assessments in Canada Using a Principle-Based Approach, Regulatory Toxicology and Pharmacology 50 (2008) 336–344

Meek¹

2009

Regulatory Toxicology and Pharmacology

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Perspectives to Performance of Environment and Health Assessments and Models—From Outputs to Outcomes?

Pohjola

Tainio

et al. 2013

IJERPH

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The calls for knowledge-based policy and policy-relevant research invoke a need to evaluate and manage environment and health assessments and models according to their societal outcomes. This review explores how well the existing approaches to assessment and model performance serve this need. The perspectives to assessment and model performance in the scientific literature can be called: (1) quality assurance/control, (2) uncertainty analysis, (3) technical assessment of models, (4) effectiveness and (5) other perspectives, according to what is primarily seen to constitute the goodness of assessments and models. The categorization is not strict and methods, tools and frameworks in different perspectives may overlap. However, altogether it seems that most approaches to assessment and model performance are relatively narrow in their scope. The focus in most approaches is on the outputs and making of assessments and models. Practical application of the outputs and the consequential outcomes are often left unaddressed. It appears that more comprehensive approaches that combine the essential characteristics of different perspectives are needed. This necessitates a better account of the mechanisms of collective knowledge creation and the relations between knowledge and practical action. Some new approaches to assessment, modeling and their evaluation and management span the chain from knowledge creation to societal outcomes, but the complexity of evaluating societal outcomes remains a challenge.

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Improving the quality of risk assessments in Canada using a principle-based approach

Cited by 3 publications

References 7 publications

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

Letter to the Editor in Response to Forristal et al.: Improving the Quality of Risk Assessments in Canada Using a Principle-Based Approach, Regulatory Toxicology and Pharmacology 50 (2008) 336–344

Perspectives to Performance of Environment and Health Assessments and Models—From Outputs to Outcomes?

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