Relevance and feasibility of principles for health and environmental risk decision-making

ABSTRACT

Globally, national regulatory authorities are both responsible and accountable for health and environmental decisions related to diverse products and risk decision contexts. These authorities provided regulatory oversight and expedited market authorizations of vaccines and other therapeutic products during the COVID-19 pandemic. Regulatory decisions regarding such products and situations depend upon well-established risk assessment and management steps. The underlying processes supporting such decisions were outlined in frameworks describing the complex interactions between factors including risk assessment and management steps as well as principles which help guide risk decision-making. In 2022, experts in risk science proposed a set of 10 guiding principles, further examining the intersection and utility of these principles using 10 diverse risk contexts, and inviting a broader discourse on the application of these principles in risk decision-making. To add to this information, Canadian regulatory practitioners responsible for evaluating health and environmental risks and establishing policies convened at a Health Canada workshop on Principles for Risk Decision-Making. This review reports the results derived from this interactive engagement and provides a first pragmatic analysis of the relevance, importance, and feasibility of such principles for health and environmental risk decision-making within the Canadian regulatory context.

KEYWORDS:

• Risk decision-making
• risk principles
• regulatory context
• risk science
• concept mapping

Acknowledgments

We would like to thank Dr. Agnes Grudniewicz, Telfer School of Management, University of Ottawa, for her input on the proposal for this study and her ongoing support and guidance. Mr. Andrew Raven, Manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit, Health Canada, for his insights on the statistical approach used in this paper and agreeing to review an earlier version. We are also grateful to Xaand Bancroft and Olivia Paige Magwood, Interdisciplinary School of Health Sciences, University of Ottawa, for their insightful comments on an earlier version of this paper. We would also like to thank the four referees for their thoughtful and constructive comments, which served to improve the clarity and focus of our original submission.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Supplemental material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10937404.2024.2338078.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Notes

1. NAMs is term broadly used to encompass non-animal methods, alternatives, and technologies that reduce reliance on traditional animal toxicology data while focusing efforts on more humane and human-relevant science.

2. Likert scale (4-point): 3, 2, 1, and 0 for highly feasible/important, somewhat feasible/important, largely not feasible/important, and left blank or no response, respectively.

3. The University of Ottawa and Health Canada’s Research Ethic Boards confirmed that ethics approval or informed consent was not required for this workshop.

Additional information

Funding

This work was not supported by any external funds.