Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules
Content Authors:
Janet Holcombe, J.D.
The Children's Hospital of Philadelphia
Charlotte Talman, M.S.N., M.B.A.
Introduction
To promote objectivity in federally funded research, the U.S. Public Health Service (PHS) has adopted specific regulations on financial conflicts of interest (FCOIs). Previously issued PHS regulations have been revised, and researchers are required to be familiar with the revised regulations and the content of institutional policies regarding conflicts if they have or plan to have responsibility for the design, conduct, or reporting of such research.
Learning Objectives
By the end of this module, you should be able to:
Describe how PHS regulations relate to FCOIs.
Recognize various forms of FCOIs in research.
Identify the members of the research team who are required to disclose FCOIs.
Identify the significant financial interests (SFIs) that investigators are required to disclose to their institutions.
Recognize the ongoing obligations that investigators have relating to FCOIs.
Conflicts of Interest: An Overview
Professionalism and the Ethical Conduct of Research
A conflict of interest (COI) is any circumstance where personal, professional, financial, or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations, or may be perceived as doing so.
Research COI can take many forms. For example, close personal or working relationships with peers or mentors may have the potential to influence the independence of a researcher's judgment or actions, sometimes in subtle ways that even the researcher does not perceive. Pressure on faculty or others to publish may also introduce bias at various points in the research process, whether during the stage of design of the study, recruitment of study subjects (for research involving human subjects), data...