FCOI Core Program Disclosure Review and Management

Description

Disclosure

Under Penn’s FCOI policy, you may be required to disclose in the Financial Interest Disclosure Electronic System (FIDES) certain, relevant financial interests/relationships, Significant Financial Interests or SFIs.

If you are an Investigator (defined as any individual responsible for the design, conduct, or reporting of research, regardless of title or position) on a proposal or IRB protocol, regardless as to the source of research funding, you must submit an “Outside Interests and Activities” disclosure in RIA prior to participating in the research, as well as at other times throughout the life of the project or study (e.g., at least once per year and within 30 days of acquiring a new SFI). Depending on the nature and value of financial interests disclosed and whether such interests are determined by your School to be related to the research, Investigators may be required to complete a research relatedness assessment, also in RIA. An SFI is “related” to research if the research could affect the value of the SFI, or if the SFI is in an entity that could be affected by the research.

Note: RIA has replaced the FIDES disclosure system, which will remain accessible only as a reference and in read-only mode (i.e., disclosures can no longer be made in FIDES as of March 18, 2024).

See the RIA Support Page for more information.

FCOI Review Process

Determining FCOI

Once you have completed your primary disclosure and any necessary research relatedness assessments in RIA, your school will determine whether any disclosed SFIs are “related” to the research and will require review by the Research Integrity Office (RIO) within the Office of the Vice Provost for Research. RIO Staff will determine whether your participation may be administratively reviewed or will require review by the faculty-based Conflict of Interest Standing Committee (CISC).

A Financial Conflict of Interest (FCOI) is an SFI that could directly and significantly affect the design, conduct, or reporting of the research. The University may utilize several forms of review to reasonably determine whether an FCOI exists. Generally, eDisclosures that report the following SFIs are referred to the Conflict of Interest Standing Committee (CISC) for review and management recommendations:

• A Fiduciary role on behalf of an Outside Organization and/or equity in a privately held Outside Organization;
• Equity with a value > $50,000 or > 5% ownership in a publicly traded Outside Organization if such entity is actively conducting or seeking to conduct business related to the research;
• Payments > $25,000 in the preceding 12 months from an Outside Organization;
• Intellectual property interests (not assigned to Penn or other Excluded Payers) if any income has been received from such IP interest in the preceding 12 months;
• Any interest in Intellectual Property that is the subject of a copyright, issued patent, or a patent application (regardless of its licensure or option status and whether or not assigned to Penn) if it is being tested, evaluated, or developed in, or if its commercial value could be affected by, a Clinical Trial.

In addition, other types of SFIs or instances where an Investigator has more than one type of SFI related to the research may be referred to the CISC for review.

CISC – Review and Recommendation

The CISC, which consists of members of the standing faculty and non-voting ex officio members, advises the Vice Provost for Research as to whether disclosed SFIs are related to the research and constitute FCOIs which must be managed, reduced or eliminated. At each meeting, a CISC member presents a summary of information reported in the eDisclosure, relevant information about the research, and any supplemental information. The recommendations of the CISC require approval by a majority of the voting members present during the meeting.

Standard Management Options

Whether or not submitted for CISC review, an SFI may be found to constitute an FCOI requiring management (including elimination of the SFI, where appropriate) as a condition to the Investigator’s participation in the research. The CISC has discretion to recommend a variety of management requirements, depending on the type and amount of the SFI, the nature of the research, the role of the Investigator, and other factors. These options include:

• Limitations on an Investigator’s financial interests
• Required disclosures in all publications and presentations, to study participants in the informed consent for the study, and to all the investigators, research personnel, students, trainees and others working on this research
• Compliance with additional Penn and School policies, including disclosure, review and approval of consulting or other personal service agreements and assurance that any scope of work for such agreements remains in all respects separate from and subordinate to the Investigator’s responsibilities as a Penn faculty member and employee
• Specific restrictions or conditions on the Investigator’s role in the research (e.g., appointment of a co-PI; limitation on involvement in subject selection, recruitment, data analysis); changes in the study design (e.g., blinding)
• Continuing reporting obligations
• Other requirements

Final Determination

The Vice Provost for Research makes the final determination regarding whether disclosed SFIs constitute FCOIs which must be managed, reduced or eliminated, and if management is recommended, determines the required elements of the management plan. The determination will be communicated in writing to the Investigator and other University personnel as appropriate. The Investigator will have the opportunity to review the management plan and must provide written confirmation to the OVPR of his or her acceptance of the obligation to abide by the plan.

The Investigator is required to annually certify that there have been no changes in his/her financial interests relevant to the specific research since last reported to the OVPR and that s/he is in compliance with all aspects of the management plan then in effect. In addition, the Investigator is expected to cooperate with any additional monitoring of compliance with the management plan. 

An executed management plan is required in order for the ORS to spend awarded funds. For human subjects research, the participation of any Investigator with an FCOI is subject to the IRB’s review and approval. 

Federal or Sponsor FCOI Reporting Requirements

OVPR staff will prepare, if applicable, FCOI reports required by the research sponsor or oversight agency that will contain information required by law or otherwise by the sponsor.

Requests from the Public Regarding FCOI Information

To the extent required by law or otherwise by the research award, the University will make available to the public certain information regarding FCOIs of Senior/Key personnel affiliated with the University. In the case of PHS- and PCORI-funded research, such information shall remain available for at least three years from the date that the information was most recently updated.