Investigator (FCOIR) – GCO

Refer to this definition when determining which personnel complete the COI form each year for your InfoEd application. An individual responsible for the design, conduct or reporting of the study. Since Federal Conflict of Interest regulations require that all investigators complete Conflict of Interest Forms, the definition of who meets this criteria is of special importance. ISMMS’ policy is that the following personnel always meet this definition:

• PI
• Key Personnel
• Anyone with a role that includes the word Investigator (Example: Sub-Investigator)
• Primary Mentor on a Fellowship or Mentored Career Development Award
• Faculty Personnel, either key or non-key (with some very limited and well documented exceptions where the non-key faculty is not engaged in the research)

Other ISMMS personnel may meet the Investigator definition. ISMMS leaves the following to the discretion of the PI:

• Other Significant Contributor
• Consultant
• Non-faculty, non-key personnel

Please consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty), the risk increases of an unidentified FCOI that may compromise the research enterprise.