4.6 Article

A framework is proposed for defining, categorizing, and assessing conflicts of interest in health research

Journal

JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 149, Issue -, Pages 236-243

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2022.06.001

Keywords

Relationship of interest; Conflict of interest; Declaration of interest; Conflict of duty; COI; DOI

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This study proposes an operational definition and categorization framework for conflicts of interest (COI) which can enhance transparency in health research.
Objective: We propose an operational definition of conflicts of interest (COI), a framework for categorizing interests, and an approach to assessing whether an interest qualifies as a COI.Study Design and Setting: We reviewed the literature and conducted methodological studies to inform the development of a draft framework for classifying interests.Results: We developed the following operational definition: a conflict of interest exists when a past, current, or expected interest cre-ates a significant risk of inappropriately influencing an individual's judgment, decision, or action when carrying out a specific duty. In-terest refers to a benefit (e.g., money received from industry) or to an attribute of the individual (e.g., having specific religious beliefs). The proposed framework includes seven types of interests relating to individuals (direct financial benefit, benefit through professional status, intellectual, and personal) or their institution (direct financial benefit to the institution, benefit through increasing services provided by the institution, and nonfinancial). When assessing whether an interest qualifies as a COI, one could consider its relevance, nature (e.g., cash vs. educational support), magnitude, and recency.Conclusion: The proposed operational definition and categorization framework may help journals, guideline organizations, profes-sional societies, and healthcare institutions enhance transparency in health research. (c) 2022 Elsevier Inc. All rights reserved.

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