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

      Abstract

      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 creates a significant risk of inappropriately influencing an individual's judgment, decision, or action when carrying out a specific duty”. Interest 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, professional societies, and healthcare institutions enhance transparency in health research.

      Keywords

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      Linked Article

      • Conflicts of interest: ubiquitous, unrelenting, and forever challenging
        Journal of Clinical EpidemiologyVol. 149
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          In this issue of the Journal, Akl et al. detail the results of a series of studies that has led to what they believe is an improved operational definition of conflicts of interest (COI): “A conflict of interest exists when a past, current, or expected interest creates a significant risk of inappropriately influencing an individual's judgment, decision, or action when carrying out a specific duty” ([1]-reference to manuscript). This definition is a modification of the one articulated by the Institute of Medicine in 2009: “a conflict of interest is a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest [2].” They also describe a framework for categorizing interests and an approach to determining if that interest qualifies as a COI.
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