Financial Conflicts of Interest Checklist 2010 for clinical research studies

Area of Science:

• Medical Research Ethics
• Research Integrity
• Conflict of Interest Management

Background:

• Financial conflicts of interest (fCOI) can compromise professional judgment in research.
• Bias is difficult for investigators to detect, especially retrospectively.
• Existing methods for fCOI reporting are not standardized across all study phases.

Purpose of the Study:

• To develop a standardized tool for detailed reporting of financial conflicts of interest.
• To provide funders, journal editors, and stakeholders with a reliable fCOI reporting mechanism.
• To ensure fCOI reporting occurs throughout the study process, from initiation to publication.

Main Methods:

• A 3-phase development process was employed: pre-meeting item generation, a stakeholder meeting, and post-meeting consolidation.
• The checklist was iteratively reviewed and rated by external experts (n=18), research team members (n=12), and research staff (n=4).
• The resulting checklist includes administrative, study, personal financial, and authorship information across 6 modules and 15 items.

Main Results:

• The Financial Conflicts of Interest Checklist 2010 was developed, comprising 4 sections, 6 modules, and 15 items with sub-items.
• The checklist includes a glossary of terms to ensure consistent understanding.
• Modules are designed for completion by all investigators at various study stages, with provisions for appending updated information.

Conclusions:

• The developed checklist provides a standardized approach to managing and reporting financial conflicts of interest.
• This tool aims to enhance transparency and mitigate bias in the research process.
• Stakeholder endorsement and feedback are invited to refine and promote the checklist's adoption.