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Research

What to Disclose PHS/DOE

PHS and DOE Investigators: Financial Disclosure and Training Requirements Supplement to University Policy 7.1.1

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, have implemented additional requirements beyond the University’s requirements for disclosure of Significant Financial Interests.

“Investigators” are defined as 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.  Investigators are required to complete training on Financial Conflicts of Interest and disclose Significant Financial Interests. This may include students and subrecipients depending on their role.

Training

The Investigator is required to complete the NIH Tutorial as well as reviewing ISU’s  Significant Interest Disclosure policy prior to completing the Outside Interests Disclosure Form.

Disclosure 

Prior to submission of the grant proposal, all Investigators must complete a disclosure in the Cayuse system.  PHS and DOE Investigators must disclose the following:

  • 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 non-Federal entity responsibilities:
    • With regard to any foreign or domestic publicly traded entity, a significant financial interest exists if the value of any remuneration 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    • With regard to any foreign or domestic non-publicly traded entity, a significant financial interest exists if the value of any remuneration, not otherwise disclosed as current, pending, or other support, 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 (e.g., stock, stock option, or other ownership interest);
    • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities that is not otherwise disclosed in current and pending or other support disclosures, provided that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.
Interests Exempt From This Reporting Requirement

The following do not need to be disclosed:  

  • Salary, royalties, or other remunerations paid by Illinois State University; including intellectual property rights assigned to ISU 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.
Subrecipients

Written agreements with subrecipients must indicate whether the subrecipient complies with FCOI requirements in one of two ways:

  1. I the financial conflict of interest policy of the recipient non-Federal entity and the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the recipient non-Federal entity; or
  2. the financial conflict of interest policy of the subrecipient will apply to the subrecipient's Investigators.  The subrecipient shall certify as part of the agreement referenced above that its policy complies with this DOE Interim COI Policy and the subrecipient shall make such policy available via a publicly accessible website. The agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the recipient non-Federal entity.