Getting Started with FCOI

Prior to submitting a Financial Conflict of Interest (FCOI) Disclosure, it is important to know who should disclose a FCOI, when an FCOI should be disclosed, and how to disclose a FCOI.

Who Should Disclose A FCOI?

Key personnel involved with sponsored projects and research studies at Howard university are required to disclose financial conflicts of interest or lack thereof and follow a management plan in the case that a significant financial interest is present. It is important that key personnel on these sponsored projects and research studies understand what to submit and when to submit it.

Key Personnel include research Principal Investigators, Project Directors, and any other personnel considered essential to work performance and those identified as Key Personnel on a contract proposal, grant, or contract.

When Should FCOI Be Disclosed?

Following the NIH FCOI guidelines, Howard University requires that all key study personnel submit a FCOI Disclosure Form:

• At the time submission of a new grant and/or protocol application. 

• Within 30 days of acquiring or discovering a new Significant Financial Interest (SFI). 

• Annually in the form of an update. 

What is a Significant Financial Interest (SFI)?

Federal Regulation 42 CFR Part 50, Subpart F defines Significant Financial Interest as a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

• With respect to any publicly traded entity, SFI exists if the value of any remuneration (other than remuneration described in SBIR, STTR and general exclusions) received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are salary, consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure of fair market value.

• With respect to any non-publicly-traded entity, SFI exists if the value of any remuneration (other than remuneration described in SBIR, STTR and general exclusions) received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse, or dependent children) holds any equity interest.

• Intellectual property rights and interests, upon receipt of income, during the twelve months preceding disclosure from such rights and interests.

• In the case of travel, investigators must disclose the occurrence of any sponsored travel or reimbursements made to or on behalf of, the Investigator, regardless of amount, by a for-profit or non-profit entity related to the Investigator’s Institutional Responsibilities. However, SFIs do not include travel reimbursed or paid by a federal, state, or local government agency, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with an institution of higher education. 

The following are not considered as SFI.

• Financial interests of any amount in, or income from, investment vehicles, such as mutual funds or retirement accounts so long as the Investigator does not directly control the investment decisions made in these vehicles.

• Payments to the University, or via the University to the individual, that are directly related to reasonable costs incurred in the conduct of research as specified in the research agreement(s) between the sponsor and the University.

• Salary and other remuneration from the University, including approved faculty practice plan earnings and the distribution of those earnings that may be established by departmental or other similar agreements provided that those agreements and departmental/divisional group plans are approved by an authorized University Official.

• Income from seminars, lectures or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

• Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

• Reimbursed or sponsored travel that is reimbursed or sponsored by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, or a research institute that is affiliated with an institution of higher education. 

How To Submit A FCOI Disclosure

All FCOI disclosures must be submitted and processed in the iRIS electronic compliance platform. Visit the iRIS page for information on how to access the platform.

Research studies that involve a regulatory compliance component and are submitted in iRIS automatically request key personnel to complete a FCOI disclosure form in the iRIS platform.

Key personnel of sponsored projects that do not include a regulatory compliance component (animals, human participants, biohazardous material, investigational drugs or devices, etc.) will have to complete the Grant-Related Conflict of interest Disclosure Form in the iRIS platform. Once the disclosure is processed by the ORRC and COIRC, an outcome letter will be provided. This letter may be included in the initial sponsored project submission. Annual disclosure updates may be completed in iRIS and included in annual project reports.