The Public Health Service (i.e., NIH) regulations, and the KSU FCOI policy, indicate that anyone who is an Investigator on a project needs to receive training and file a COI disclosure. An Investigator is the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, collaborators or consultants. Investigator includes, but is not limited to, the Principal Investigator, project director, co-principal investigator, and may also include other Senior/Key Personnel, a postdoctoral fellow, graduate student, trainee, staff member,
collaborator, or consultant, depending on the person’s role in the research.
The primary factors to be used in determining who is an Investigator are the significance
of the tasks assigned to the individual regarding the design, conduct, and reporting
of the research and the degree of independence that individual may have in performing
such research-related tasks. The Public Health Service (PHS) Financial Conflict of Interest (FCOI) regulation applies to all individuals defined as project Investigators. It is up to the Principal
Investigator of the project to determine who meets these criteria.
Determinations of Investigator status are distinct from determining PI Eligibility
for proposal submissions.
In addition, the following individuals will always be considered Investigators:
- Principal Investigator, including Multiple PIs (those with equal responsibility for
the project)
- Co-Principal Investigator
- Co-Investigator
- Sponsor for Postdoctoral or Graduate Fellows
- Postdoctoral or Graduate Fellows paid on Fellowships
- Anyone named Senior/Key Personnel on the proposal submission
Subrecipients, while also always considered investigators, must comply with the FCOI
policy of their home institution.
If ANY of following questions can be answered “YES” for an individual, they ARE considered an Investigator.
- Is the individual responsible for the design of any the research?
- Is the individual responsible for the conduct of any the research?
- Is the individual responsible for the reporting of any of the research?
- Is the individual responsible for any programmatic outcomes?
- Will the individual be a collaborator on a publication related to the research? For example: Will they be listed as an author on a publication that cites the award as a ‘Funding Source?’