PHS and DOE Investigators: Financial Disclosure and Training Requirements

FCOI Compliance

The Department of Health and Human Services, through its regulation 42 CFR Part 50 Subpart F, and the Department of Energy, through its Interim Conflict of Interest Policy Requirements for Financial Assistance, require additional compliance steps relative to Financial Conflicts of Interest.

All “investigators” – the PI, co-PI, senior/key personnel, and anyone—regardless of title or position—who is responsible for the purpose, design, conduct, or reporting of the sponsored research – are required to complete training on Financial Conflicts of Interest and disclose Significant Financial Interests.

DOE Interim Policy on Conflicts of Interest Overview PPT

How to Comply

FCOI Training

Investigators on Public Health Service or Department of Energy awards must complete a university-approved Financial Conflict of Interest training prior to engaging in research and thereafter, every four years and immediately when any of the following circumstances apply:

  • The university revises the Policy of Conflict of Commitment and Interest and procedures in any manner that affects the requirements of the investigator to comply with the regulation;
  • An investigator is new to the University of Illinois;
  • The university finds that an investigator is not in compliance with the university’s Policy on Conflicts of Commitment and Interest or with the university-approved management plan.

If you are an investigator on an existing award, training must be completed prior to the continuing review of the award. Online training can be completed at START myDisclosures.

FCOI Compliance: Who Does What When and Where
Compliance Who What When Where
General Investigators Train Before working on the project and every four years thereafter STARTmyDisclosures
or
Live training from OVCRI
General Investigators Disclose Before working on the project
Annually
Within 30 days of a new SFI
STARTmyDisclosures
Project-specific PI Certify that personnel are compliant or will be before award Proposal submission myResearch Portal
Project-specific Anyone with IPN/Review ID Document T&D compliance Award setup and each increment of funds myFCOI Checklist
Project-specific COI office Identify and report FCOIs At award setup and as new disclosures are filed myFCOI Checklist

Disclosure of Significant Financial Interests

You must disclose your significant financial interests (SFIs) and SFIs of your family when your funding proposal is submitted to the university or before you work on an award subject to additional FCOI compliance. You must update your disclosure annually and within 30 days of any newly acquired or discovered SFIs or changes in the reported SFIs on awarded grants (regardless of the type of award, including federal flow-through) and extensions (with or without funding).

Go to START myDisclosures to complete the Sponsor Specific Questionnaire.

Examples of Significant Financial Interests Required to be Reported

Financial Interest Examples Thresholds for SFI
Remuneration, income, salary, and any payment for services Consulting fees, honoraria, paid authorship. $5,000 or more.
Public equity interest Stock, stock option, or other ownership interest. The present-day market value of $5,000 or more.
Private equity interest Stock, stock option, or other ownership interest. Any ownership interest regardless of percentage or the dollar value.
Intellectual property (IP) rights and interests Patents not assigned to the University of Illinois; licenses from the University of Illinois to an external entity; copyrights; royalties that are not paid by the University of Illinois. When profit or remuneration from IP interests meets or exceeds $5,000.
Fiduciary role The executive role is a voting member of the board. Report fiduciary relationships (even if unpaid) that may be reasonably related to your research or university responsibilities; or with an entity that does business with the university.
Sponsored or reimbursed travel Travel paid by an external entity (including airfare, gas, car rental, hotel room meals, stipends, etc.). Travel must be reported from any entity unless the travel is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined by 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. $5,000 de minimize for reporting.
Foreign financial interests Financial interests are received from a foreign institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country). $5,000 or more.


Interests Exempt From This Reporting Requirement

Exemptions

You do not need to disclose:

  • Salary, royalties, or other remunerations paid by the University of Illinois; including intellectual property rights assigned to the University of Illinois and agreements to share royalties related to such rights.
  • Income from investment vehicles (mutual funds or retirement accounts that are not managed directly by the individual).
  • Income from seminars, lectures, or teaching engagements sponsored by a US federal, state, or local government agency, a U.S. Institution of higher education as defined by 20 U.S.C. 1001(a); an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education.
  • Income from service on advisory committees or review panels for a US federal, state, or local government agency, a U.S. institution of higher education as defined by 20 U.S.C. 1001(a). (e.g., NIH review panel).
  • Travel that is reimbursed or sponsored by a US federal, state, or local government agency, a U.S. institution of higher education as defined by 20 U.S.C. 1001(a); an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education.

Documenting Compliance

"Just in Time" Disclosure, FCOI Management and Training for Awards and Renewals

Prior to initial award, renewal, or continuation, principal investigators will be asked to certify that financial disclosures, travel disclosures, and training are up to date for all investigators participating in the project using the myFCOI Checklist.

If between the time of proposal and the time of award an investigator has acquired a significant financial interest, he or she should use the Sponsor Specific Questionnaire within the START myDisclosures system to disclose the unreported interests.

Reopening an FCOI Checklist

MyFCOI checklist documents compliance with sponsor-specific financial conflict of interest regulations and policies throughout the life of an award. The system allows users to reopen and revise an approved checklist throughout the year. Checklists should be updated when new personnel join the project and when the PI, co-I, or senior/key personnel leave the project.

Guide to Reopening the FCOI Checklist
 

Ongoing Disclosures and Training

  • All PHS and DOE-funded investigators must be trained concerning the FCOI requirements and the University of Illinois Policy on Conflicts of Commitment and Interest prior to initiating work on a project.
  • PHS and DOE-funded investigators must continue to disclose significant financial interests within 30 days of acquiring a new interest.
  • Investigators who join a project must complete training and disclose significant financial interests upon joining the project and then continue to disclose significant financial interests on an ongoing basis.
  • Any financial conflicts of interest that are identified must be managed or eliminated within 60 days.
  • Externally sponsored or reimbursed travel must be disclosed by PHS and DOE investigators within 30 days of travel.

If you have questions please contact COI office staff (coi@illinois.edu, 217-333-0034).