Financial Conflict of Interest (FCOI)

Promoting objectivity in Research is refined in 42 CFR 50 Subpart F [PDF]. The Office of Research is responsible for research-related financial conflicts of interest (FCOI). Defined in 42 CFR 50.603 [PDF], disclosure of significant financial interests means an Investigator’s disclosure of significant financial interests to an Institution.

What is a Financial Conflict of Interest (FCOI)?

Conflicts of interest in research are present when Significant Financial Interests directly affect, or could appear to affect, the professional judgment of a researcher when designing, conducting, or reporting research.

Who needs to disclose?

• All Drexel investigators must disclose at least annually
• Non-Drexel investigators must disclose only those Significant Financial Interests (SFI) related to their research

What is considered an SFI?

An SFI is present when any of the following are received by an Investigator or their Immediate Family Member:

• Combined income or equity exceeding $5,000 in a publicly traded company
• Income exceeding $5,000 or any equity in a privately held company
• Income exceeding $5,000 from Intellectual Property managed by Drexel as well as IP managed by another institution
• Sponsored/reimbursed travel exceeding $50

When and how do I disclose?

Annually all Principal Investigators (PI's) and key personnel responsible for conducting or designing research should complete the COI disclosure form as it relates to ongoing research. In addition, at the time of proposal submission or when there is significant change, principal investigators and key personnel should submit an FCOI disclosure form. The form can be found here.

Conflicts are reasonably expected to be disclosed when:

• The conflict has a direct and significant impact on the design, conduct or reporting of the sponsored project
• The conflict has the potential to undermine University personnel's obligation to Drexel, the sponsor, research subjects or students.

Why do I need to disclose?

Federal regulations require Drexel to have policies in place to promote objectivity in research for which Public Health Service (PHS) grants or cooperative agreements are sought, 42 CFR Part 50 Subpart F [PDF], as well as to address Drexel’s Conflict of Interest and Commitment, Policy Number CPO-2. The Office of Research and Innovation’s COI Policy [DOC] can be viewed here.

Institutional Training of Investigators

The Institution must train their Investigators (and ensure subrecipient Investigators are trained) about the FCOI regulations, the Institution’s policy, and the Investigator’s responsibility to fully disclose all domestic and foreign SFIs (and those of their spouse and dependent children) that are related to their institutional responsibilities.

Requirements/Frequency

Completion of the education is required upon hire and prior to engaging in the design, conduct, or reporting of research.

1. Renewal of the education will be required every four years.
2. Education will also be required if Drexel ORI revises its FCOI policy.
3. Education will also be required when an investigator is not compliant with an FCOI management plan.

Process

Training is provided through a web-based education module. Click here to access FCOI training information.

COI Committee

The Conflict of Interest Committee reviews the reporting forms to determine whether a significant financial interest is related to the investigator's Drexel research and whether it constitutes an FCOI. Once an FCOI has been identified, the committee recommends a management plan and implementation mechanisms for monitoring to the Executive Vice Provost for Research.