Categorizing conflicts of interest in healthcare research: a proposed framework

Article type
Year
Authors
Akl EA1, Hakoum MB1, El-Jardali F2, Guyatt G3
1Clinical Research Institute, American University of Beirut Medical Center, Lebanon
2Department of Health Management and Policy, American University of Beirut, Lebanon
3Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada
Abstract
Background: A conflict of interest arises from a relationship that could unduly affect an individual’s judgment. The healthcare research community is becoming increasingly concerned with non-financial conflicts of interest, such as intellectual, professional, and institutional conflicts.

Objectives: We propose a framework to categorize conflicts of interest and assess their extent.

Methods: We developed an initial draft based on a review of the published literature regarding conflict of interest (COI) definitions, types, disclosure policies, management policies, and existing disclosure tools (e.g. International Committee of Medical Journal Editors disclosure form). We tested and refined the framework through methodological surveys addressing the reporting of COI in clinical systematic reviews and randomized controlled trials, and health policy and systems reviews and primary studies.

Results: The framework categorizes COI as either individual or institutional, and as either financial or non-financial. It includes 10 categories: individual COIs, which include financial, professional, scholarly, advocatory, and personal; and institutional COIs, which include financial, professional, scholarly, advocatory, and cultural. The framework also includes subcategories of COI and is accompanied by specific definitions and instructions for the different categories and subcategories of COI. It includes guidance on how to assess the extent of financial COIs (e.g. source, duration, monetary value).

Conclusions: Journals and organizations may find the proposed framework useful for disclosure of COIs. Researchers studying the field of conflict of interest could use the framework to classify and measure their extent and impact. This framework could also serve as the basis for management of COIs. Although such a detailed framework might increase the burden of reporting and managing COIs, it will help make judgments of individuals more transparent and less arbitrary. In the next step, we will refine the framework by incorporating input from experts in the field.