Guidelines to develop the Significant Financial Interest – Disclosure and Management Plan (SFI-DMP)
Disclosure & Management Heading link
Significant financial interest must always be disclosed. Once disclosed, potential or actual financial conflicts of interest (FCOI) must be managed or eliminated. Having a FCOI is a function of the situation, and does not imply improper behavior.
1.Elimination of the Conflict Heading link
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1.Elimination of the Conflict
For situations in which the elimination of the potential FCOI is desired (e.g. where management is insufficient to protect the objectivity of the research), several options are possible. For example:
- the conflicted Investigator may elect to cease consulting for the study sponsor or to divest his/her ownership interests in the company sponsoring the study.
- the conflicted Investigator may choose not to participate in the study, and have the study conducted by an non-conflicted investigator.
- Modification of the research plan.
- Change of research personnel or personnel responsibilities.
- Reduction or elimination of the financial interest. (e.g., sale of any equity interest)
- Severance of relationships that create financial conflicts of interest.
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2. Management of the Conflict
For situations in which the management of the potential FCOI is desired, then the Investigator is required to disclose and manage activities using (i) the Report of Non-University Activities (RNUA) and (ii) the Significant Financial Interest-Disclosure and Management Plan (SFI-DMP) form.
SFI-Disclosure Heading link
The Significant Financial Interest-Disclosure and Management Plan (SFI-DMP) includes the following sections:
1. Definition of Significant Financial Interest (SFI) Heading link
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1. Definition of Significant Financial Interest (SFI)
Significant Financial Interest (SFI) (42 CFR 50.603) consists of one or more of the following interests of the Investigator (and those of the Investigator’s family) that appear to be reasonably related to the Investigator’s University responsibilities:
- With regard to any publicly traded entity, a significant financial interest (SFI) 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 measure of fair market value;
- With regard to any non-publicly traded entity, a significant financial interest (SFI) exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator or Investigator’s family holds any equity interest (e.g., stock, stock options, or other ownership interest);
- Any other relationships that might present a conflict of interest, such as fiduciary interests (paid or unpaid positions as director, officer, or other management role in a for-profit or not-for-profit entity sponsoring or related to the research) or interests in which compensation or the value of equity or property rights or the combination of interests might affect the outcome of the research.
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators must also disclose the occurrence of any reimbursed or sponsored travel. There is a $5000 de minimis for reporting sponsored or reimbursed travel.
- With regard to any publicly traded entity, a significant financial interest (SFI) 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.
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2. Exempt from the significant financial interests and reimbursed or sponsored travel from the reporting requirements are:
- 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 account that are not managed directly by the individual);
- Income from seminars, lectures, or teaching engagements 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;
- Income from service on advisory committees or review panels for a Federal, state, or local government agency, an 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 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.
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3. Relationship with the external entity
- Remuneration
Remuneration includes salary and any payment for services (e.g., consulting fees, honoraria, paid authorship, or other supplemental income), which are not exempted from the disclosure requirements as described in the definition of significant financial interest (SFI). You must indicate the level of the financial interest according to the range categories listed on the form; if the value is greater than the range options, then you must specify the amount; or you must indicate that the value cannot be determined by reference to public prices or other reasonable measures of fair market value.
- Equity
Equity interests include any stock, stock options, or other ownership interest. If you have equity interest in the external entity, you must indicate that total percentage of equity owned; specify if the equity is publicly or privately traded; if the equity is publicly traded, then you must indicate the level of the financial interest (e.g., the current market value at the time of disclosure) using the range values listed on the form; if the value is greater than the range options, then you must specify the amount; or you must indicate that the value cannot be determined by reference to public prices or other reasonable measures of fair market value.
- Intellectual property rights and interests
You must disclose the ownership of intellectual property rights and interests when earning from the intellectual property rights reach the significance threshold of $5,000 or if the intellectual property is licensed from the University of Illinois. Intellectual property also includes patents not assigned to the University of Illinois; licenses from the University of Illinois to the external entity; copyrights; royalties that are not paid to the academic staff member by the University of Illinois.
- Fiduciary role
You must disclose if you have a fiduciary role (e.g., executive role, a voting member of the board), even if unpaid, with the external entity.
- Sponsored or reimbursed travel
You must indicate if the external entity sponsors or reimburses you for travel. There is a $5000 de minimus for disclosing sponsored or reimbursed travel. If you indicate that the external entity sponsors or reimburses your travel, then you must provide additional explanation in your SFI-Disclosure.
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4. Reimbursed or sponsored travel
Travel that is reimbursed or sponsored by an external entity (including airfare, gas, car rental, hotel room, meals, stipends, etc) must be disclosed when it reaches the $5,000 de minimus for any single external entity. Investigators that receive reimbursement for travel from an external entity or are sponsored by an external entity for travel must provide the following information:
- purpose of the travel
- destination(s)
- duration (total # of days in the 12 months preceding the disclosure)
- aggregate value of travel expenses. You must indicate the level of the financial interest according to the range categories listed on the form; if the value is greater than the range options, then you must specify the amount; or you must indicate that the value cannot be determined by reference to public prices or other reasonable measures of fair market value.
Exempt from the disclosure requirement is travel that 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.
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5. SFI related to the Investigator’s research
The process for assessing if the SFI is related to the Investigator’s research requires the cooperation and self-disclosure of the Investigator. The Investigator should consider if the SFI is or could be reasonably related to the Investigator’s sponsored research. An SFI would be considered reasonably related if:
- the entity is or may be the sponsor of the research.
- the entity’s products (including drugs or devices) or service(s) is or may be utilized, tested, evaluated, or otherwise in any sponsored research projects for which you serve as an investigator.
- entity does/will license University intellectual property utilized, tested, evaluated, or otherwise in any research projects for which you serve as an investigator.
- the Investigator’s institutional responsibilities may involve or require interacting with the external entity (e.g, Investigator serves on a University formulary committee, the Investigator makes purchasing decisions, the Investigator reviews contracts between the University and the external entity).
If the Investigator identifies that the SFI is reasonably related to the Investigator’s sponsored research, then the Investigator should list award, or institution number(s) or study title(s).
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6. Continuation of the relationship
The Investigator should identify if the relationship with the external entity will continue over the next 12 months from the date of disclosure.