Investigators, which includes any individual responsible for the design, conduct, or reporting of the research.

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1 FAQs: Significant Financial Interests-Disclosure and Management (SFI-DMP) The following FAQs help to answer frequently asked questions regarding the University s policies and procedures for Investigator disclosure of Significant Financial Interests (SFIs) and Travel disclosure requirements of the 2011 Public Health Services (PHS) Regulation, Department of Health and Human Services (HHS) 42 CFR Part 50 and 45 CFR Part 94. They may also provide guidance for SFI disclosure by Investigators on other sponsored research. (1) Which forms are used for Investigator financial disclosure on sponsored research? (2) Which financial or fiduciary relationships require reporting? (3) When is a significant financial interest and sponsored or reimbursed travel exempt from reporting? (4) What is a significant financial interest (SFI)? (5) What is the de mimimis for disclosing sponsored or reimbursed travel? (6) Who is required to disclose significant financial relationships on funding proposals? (7) What is the definition of an Investigator? (7a) Do the federal regulations apply to a consultant or a collaborator who is not employed by the University of Illinois? (7b) Do the federal regulations apply to a Post-doctoral Fellow? (7c) Do the federal regulations apply to a graduate student? (8) Who qualifies as senior / key research personnel on PHS sponsored research? (9) Is the investigator required to report the significant financial interests of family members? (10) What time period does the disclose cover? (11) What is the timeframe for disclosing? (12) When should I update the SFI-DMP: Part I form? (13) What is a Financial Conflict of Interest (FCOI)? (14) What happens when a SFI is determined to be an FCOI? When is the SFI-DMP: Part II form required? (15) What if I have a no-cost extension, do I have to continue to disclose and manage FCOIs? (16) Will my disclosure be made publicly available? (17) Am I still required to complete the Report of Non-University Activities (RNUA) form? (18) Where can I find guidance on how to fill-out the SFI-DMP form? (1) Which forms are used for Investigator financial disclosure on sponsored research? Forms Who should use this form? Details Significant Financial Interest Disclosure and Management Plan (SFI- DMP): Part I Investigators, which includes any individual responsible for the design, conduct, or reporting of the research. Senior/Key Research Personnel on HHS/PHS/NIH sponsored research, unless the person is identified by the PI as NOT an investigator. (See guidance in FAQs #7 & 8) In Part I, Investigators provide a listing of their Significant Financial Interests (SFIs) and sponsored or reimbursed travel related to the Investigator s University responsibilities. In some cases, disclosure may be sufficient for management and only Part I will be used to document disclosure and management. Significant Financial Interest Disclosure and Management Plan (SFI- DMP): Part II On determination by University Designated Officials that a SFI is related to a research project and the SFI represents a Financial Conflict of Interest (FCOI), the form should be completed by Investigator(s) with the FCOI. Part II presents management mechanisms for FCOIs. Relatedness of the SFI may be identified by the Investigator, PI/PD, Unit Executive Officer, COI Office, Office of Research Services, IRB, or other University official.

2 (2) Which financial or fiduciary relationships require reporting? The table below includes financial interests that require disclosure. All financial interests with a single entity must be considered in aggregate. Examples to illustrate are included below the table. Financial Interest Examples Thresholds for SFI Remuneration, income, Consulting fees, honoraria, paid $5,000 or more salary, and any payment for services authorship Public equity interest Stock, stock option, or other ownership interest 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 dollar value. Intellectual Property (IP) rights and interests Fiduciary role 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 Executive role, a voting member of the board When profit or remuneration from IP interests meets or exceeds $5,000. 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 minimis for reporting. Examples of scenarios when the SFI threshold is met and the financial interest must be disclosed: Example 1 (Remuneration & Equity): If you receive remuneration from Company A for $2,000 and you have an equity interest in Company A which has a present day value of $3,000, then the SFI $5,000 threshold for Company A is met and you must disclose your activities with Company A. ($2,000 remuneration + $3,000 equity = $5,000 total SFI that must be disclosed) Example 2 (IP & Equity): If you receive royalties directly from Company A for $2,000 and you have publicly traded stock that you control in Company A worth $3,000, then the SFI $5,000 threshold for Company A is met and you must disclose your activities with Company A. ($2,000 direct royalties + $3,000 public equity = $5,000 total SFI that must be disclosed)

3 Example 3 (Travel): If you are sponsored or reimbursed from Company A for travel to Company A s meeting, you must disclose the travel when the amount of the sponsored or reimbursed travel equals or is greater than $5,000. 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. Examples of scenarios when the financial interest does not meet SFI threshold and disclosure of the financial interest to the University is optional: Example 1 (Remuneration & Equity): If you receive remuneration from Company A for $2,000 and you have an equity interest in Company B (a separate entity) which has a present day value of $3,000, then the SFI $5,000 threshold has not been met and disclosure of your relationship with Company A and Company B is optional. Example 2 (IP & Equity): If you receive royalties from Company A for $2,000 paid through the University and you have publicly traded stock that you control in Company A worth $3,000, then the SFI $5,000 threshold has not been met and disclosure of your relationship with Company A is optional. Because the University pays you for the royalties, the income derived from royalties paid by the University of Illinois is not considered to be external income that requires disclosure. Example 3 (Travel): If you are paid by the University for travel to Company A s meeting, then you are not required to disclose the travel. (3) When is a significant financial interest and sponsored or reimbursed travel exempt from reporting? The PHS regulation (42 CFR ) exempts the following significant financial interests and reimbursed or sponsored travel from the reporting requirements: 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 (4) What is a significant financial interest (SFI)? A Significant Financial Interest (SFI) (42 CFR ) is identified when: The value of any remuneration received from an external entity at present or in the 12 months preceding the disclosure that when aggregated for the individual, one s spouse or domestic partner, parents, siblings, and children totals or exceeds $5,000. The $5,000 threshold also applies to salary, royalties, and other payments aggregated for the individual, one s spouse or domestic partner, parents, siblings, and children. Publicly-traded equity if the value of the equity (plus any remuneration) meets or exceeds $5,000. Any level of ownership of privately-held equity regardless of the dollar value. (5) What is the de mimimis for disclosing sponsored or reimbursed travel?

4 For investigators on PHS sponsored researcher, or as required by the sponsor, there is a $5,000 de minimis for disclosing reimbursed or sponsored travel (42 CFR ). The University, through its designated officials, must determine if the travel represents a Financial Conflict of Interest (FCOI). (6) Who is required to disclose significant financial relationships on funding proposals? All investigators, which includes anyone that is responsible for the design, conduct, and reporting of the research, must disclose significant financial interests on funding proposals by completing the COI Certification on the Proposal Approval Form (PAF) at the time of submission to the Office of Research Services. (7) What is the definition of an Investigator? An Investigator is defined as the project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the sponsored research or proposed sponsored research, which may include, for example, collaborators or consultants. The PI must consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases. (7a) Do the federal regulations apply to a consultant or a collaborator who is not employed by the University of Illinois? Yes. If the consultant or collaborator meets the definition of investigator. If the consultant or collaborator is covered by a sub-contract agreement between the University of Illinois and an institution that attests to having a FCOI policy that meets the requirements of the federal regulations; then the consultant or collaborator would follow the FCOI policy at the sub-recipient institution. If the consultant or collaborator is not under any sub-contract agreement with the University of Illinois, then the consultant or collaborator must follow the University of Illinois Policy on Conflict of Commitment and Interest; complete the University of Illinois FCOI training; and submit disclosures of significant financial interests to the University of Illinois. (7b) Do the federal regulations apply to a Post-doctoral Fellow? Yes. If the Post-doctoral Fellow meets the definition of investigator. (7c) Do the federal regulations apply to a graduate student? Yes. If the graduate student meets the definition of investigator. (8) Who qualifies as senior / key research personnel on PHS sponsored research? Senior/Key Personnel means the Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to the HHS/PHS/NIH by the University. All senior/key personnel must be listed of the FCOI Checklist, however, the PI may determine that a senior/key person does not meet the definition of Investigator. (9) Is the investigator required to report the significant financial interests of family members?

5 Yes. According to the University Policy on Conflict of Commitment and Interest, family members include spouse or domestic partner, parents, siblings, and children when the family member s significant financial interest is reasonably related to the investigator s research or University responsibilities; or if the family member has a financial interest in an entity that contracts or does business with the University. (10) What time period does the disclosure cover? Per the PHS regulation, you must report significant financial relationships that exist at present and those that occurred in the 12-month period preceding the date of disclosure. If you anticipate engaging in an external activity that may represent a significant financial interest (SFI), sponsored or reimbursed travel, or a fiduciary role over the next academic year, you may prospectively report the activities. (11) What is the deadline for disclosing? To comply with PHS regulation 42 CRF Part 50 and 45 CRF Part 94, any funding proposal submitted or Notice of Award (new or continuing) issued as of August 24, 2012 must comply with the University s revised disclosure process. The Significant Financial Interest Disclosure and Management (SFI-DMP): Part I must be completed at least annually and updated within 30 days as indicated below. Annual Disclosure HHS/PHS/NIH Investigators and senior/key research personnel must complete the SFI-DMP: Part I form annually based on the academic year (July 1, 2015 to August 15, 2016). For new and pending HHS/PHS/NIH proposals, the SFI-DMP: Part I should be completed by all Investigators and senior/key research personnel at the time of submission of the grant application to the Office of Research Services (ORS). For existing HHS/PHS/NIH awards, the SFI-DMP: Part I should be completed by all Investigators and senior/key research personnel prior to submitting the continuing review application to ORS, whether the study is funded or not (e.g., no cost extension). SFI-DMP: Part I forms that were submitted after July 1, 2015, will apply towards the AY16 disclosure year and you do not need to submit an update to the form. If you submitted your SFI-DMP: Part I prior to July 1, 2015, then you will need to update the SFI-DMP: Part I for AY16. You must update the SFI-DMP: Part I annually and within 30 days of discovering or acquiring a significant financial interest. To check if you have an updated disclosure and FCOI training on file, please consult the Weekly Tracking Report (login is required). You must complete the SFI-DMP: Part I even if you do not have any outside financial interests. Any conflicts identified by the SFI disclosure related to your University responsibilities must be managed prior to the execution of an award. Links embedded in the forms may have changed. Please be sure to download the most recent version of the disclosure form. Download the form and save it to your computer before you fill it in; then submit it to COI@uic.edu. Update within 30 days See Q12. When should I update the SFI-DMP: Part I form? (12) When should I update the SFI-DMP: Part I form? If the prospective activities disclosed on the Significant Financial Interest Disclosure and Management Plan (SFI- DMP): Part I form change during the year so that you have not included sufficient information (e.g., you will earn more than you reported, you will travel more days or to different destinations than reported), then you must

6 update the SFI-DMP: Part I form within 30 days of discovering or acquiring the new or increased financial interest and sponsored or reimbursed travel. (13) What is a Financial Conflict of Interest (FCOI)? A Financial Conflict of Interest ( FCOI ) exists when the University, through its designated official(s), reasonably determines that the SFI could directly or significantly affect the design, conduct, or reporting of the PHS-funded research. All determinations of FCOI must be managed through the Significant Financial Interest Disclosure and Management Plan (SFI-DMP): Part II form. For HHS/PHS/NIH research, the University must report on the management or elimination of FCOIs prior to expenditure of the HHS/PHS/NIH funds or within 60 days of acquiring or discovering a significant financial relationship. (14) What happens when a SFI is determined to be an FCOI? When is the SFI-DMP: Part II form required? When a significant financial interest (SFI) is determined to be reasonably related to an investigator s research or University responsibilities then the Investigator must complete Part II of the Significant Financial Interest Disclosure and Management Plan (SFI-DMP) form. (15) What if I have a no-cost extension, do I have to continue to disclose and manage FCOIs? Yes. You must continue to annually disclose SFI and manage any FCOIs. Your SFI-DMP: Part II will continue to manage the FCOI until the project has concluded. (16) Will my disclosure be made publicly available? All HHS/PHS/NIH investigator and senior/key research personnel disclosures are subject to public disclosure requirements of the PHS regulation (42 CFR ). The University must provide a written response to any requestor within 5 business days of a request. The requestor must complete the University s FCOI Disclosure Request form and submit it to the Conflict of Interest Office. The University is required to indicate if an investigator s disclosure of financial interest meets three criteria: if a Significant Financial Interest (SFI) was disclosed and is still held by the senior/key personnel; if the University determines that the Significant Financial Interest (SFI) is related to the PHS-funded research; and if the University determines that the Significant Financial Interest (SFI) is a Financial Conflict of Interest (FCOI). If the three criteria are present, the PHS regulation requires the University to provide only the following information to the requestor: the Investigator s name; the Investigator s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. The response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the University s identification of a new financial conflict of interest, which may be requested subsequently by the requestor.

7 Information concerning the significant financial interests of an individual subject to the PHS public disclosure requirements shall remain available on the University s records for responses to written requests for three years from the date that the information was most recently updated. Investigators and key research personnel must promptly comply with any further requests for information or clarification from the University. (17) Am I still required to complete the Report of Non-University Activities (RNUA) form? Yes. The Report of Non-University Activities (RNUA) disclosure is mandatory for academic staff as prescribed in the University Policy of Conflict of Commitment and Interest. Academic staff are required to update the RNUA disclosure annually and throughout their contract period if their non-university activities change. The RNUA disclosure is available at START mydisclosures: (18) Where can I find guidance on how to fill-out the SFI-DMP form? Guidelines for completing the SFI-DMP forms are available on the COI website.