1. Financial Conflict of Interest Requirements
UW Oshkosh Grants & Research Workshop
November 28th, 2017
Updated July 18, 2018
Kurt McMillen
Interim Assistant Director, Grants & Proposals
Office of Research & Sponsored Programs
University of Wisconsin – Madison
Kelly Schill
Associate Director of Research Compliance
Office of Sponsored Programs and Faculty Development
University of Wisconsin Oshkosh
1/1/2019

2. Today’s Agenda Financial Conflict of Interest
What is conflict of interest (COI) and/or financial conflict of interest (FCOI)?
Policies & regulations governing COI on sponsored programs
UW System policies
Federal regulations
FCOI regulation/policy requirements
Investigator Responsibilities
Training, disclosure, etc.
Institutional Responsibilities
Policy implementation, Disclosure review, monitoring, etc.
FCOI Process on Sponsored Programs
Few other items to keep in mind
FCOI on non-federal projects
FOCI on subawards
Questions?
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3. What is a Conflict of Interest?
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4. What is a Financial Conflict of Interest?
Exists when an investigator has a significant financial interest that could lead an independent observer to reasonably question whether the design, conduct or reporting of research might be influenced by the possibility of personal gain.
It represents a state of affairs, not behavior.
Frequently involve perceptions
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5. Where do Financial Conflict of Interests come from?
Outside Activities
UW System Faculty & Staff are encouraged to participate in outside activities, share expertise and transfer intellectual property to the private sector.
Importance of such outside activities is captured in the ‘Wisconsin Idea’. Where knowledge gained from academic enterprise is shared to benefit society
Participation in outside activities may generate the perception of a conflict between the needs of the institution and the outside entity.
Financial
Professional
Others
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6. Recognize that Conflicts of Interests are…
Common and frequently unavoidable
Not necessarily “bad”
Can often be appropriately managed
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7. Polices and Regulations
Federal Regulations
Public Health Service (NIH, CDC, etc…)
Grants: 42 CFR Part 50, Subpart F
Contracts: 45 CFR Part 94
Sponsor Policies/Requirements
Section of the NIH GPS
State of Wisconsin Statutes
Admin Code, Section UWS 8.025
UW Board of Regent Policy
Regent Policy Document 20-7
UWO FCOI Policy
UWO
UW System
Individual Sponsor Policies
Federal Regulations
State of Wisconsin Admin Code
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8. What is the Purpose of these Regulations?
“promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.”
Ensure the public’s trust that federally-supported research is conducted with the highest scientific and ethical standards
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9. Public Health Service Regulations 42 CFR Part 50, 45 CFR Part 94
Who does this apply to?
Establishes standards to be followed by institutions that apply for or receive research funding from PHS Awarding Components (NIH), for grants, cooperative agreements, and research contracts.
Any Investigator planning to participate in or participating in the research.
Investigator – “Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of a research project that is federally funded or proposed for such funding.”
What's Required?
Investigators are informed (i.e. training).
Investigators engaging in, or proposing to engage in, federally funded research are required to report all significant financial interests held by themselves or their immediate families.
Institutions must review disclosures and manage potential conflicts.
Institutions must report to funding agencies when a conflict does exist.
Institutions should monitor investigators with federal funding at least annually.
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10. PHS FCOI Regulations Framework
Implement FCOI Policy
Evaluate Disclosures
Identification of FCOI & Management if needed
Report to Federal Agency
Institution
Take training
Disclosure of significant financial interests
Comply with Institutional Policy
Investigator
Oversight
Federal Agency (NIH)
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11. Institutional Responsibilities Public Accessibility
Institution must implement an FCOI policy that is in compliance with 42 CFR Part 50.
FCOI policy must be made available via a publicly accessible Web site.
UWO FCOI Policy:
Requirements outlined in the UWO Policy:
How training should be completed.
When/How disclosure should be completed.
How disclosures will be evaluated.
Overall FCOI Process on sponsored projects.
Before spending funds for PHS-supported research, an Institution shall ensure public accessibility of information on certain significant financial interests (SFIs) that the Institution has determined are related to the PHS-funded research and are FCOI.
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12. Investigator Responsibilities Training
Investigators must complete training on conflict of interest regulations prior to engaging in research related to any federally funded sponsored project.
Completed through the CITI Program which includes a module with UW Oshkosh specific guidelines.
CITI FCOI training:
Training must be renewed at least every four years.
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13. Investigator Responsibilities Disclosure
Who?
Investigators (PI, Co-PI, Key Personnel) engaging in, or proposing to engage in, federally funded research are required to report all significant financial interests held by themselves or their immediate families that reasonably appear to be related to the investigator's institutional responsibilities.
When? - Disclosure is required:
At the time of application for a federally sponsored project
Annually – For investigators with federal funding
Ad Hoc - within 30 days of discovering or acquiring any new or additional Significant Financial Interest
How?
Disclosure is completed by completing a Financial Disclosure Form and submitting it to the Office of Sponsored Programs
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14. Investigator Responsibilities Disclosure
Financial Interest
A financial interest that is held: (1) by an individual or a member of an individual’s immediate family; or (2) by a business entity that is controlled or directed by an individual or a member of an individual’s immediate family.
Exclusions:
Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education.
If the individual does not directly control the investment decisions made in these vehicles.
Excludes income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator
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15. Investigator Responsibilities Disclosure
Significant Financial Interest
To be significant, the financial interest has to reasonably be related to the individual’s institutional responsibilities at UWO, AND also needs to meet at least one of the follow criteria:
For publicly traded entities: The value of payments received from the entity in the twelve months preceding the disclosure in combination with the value of any equity interest in the entity as of the date of disclosure exceeds $5,000.
If Payment + Equity ≥ $5,000, It’s significant
For non-publicly traded entities: The value of any payment received from the entity in the twelve months preceding disclosure, when aggregated, exceeds $5,000. Or, The investigator holds any equity interest in the entity.
Payments ≥ $5,000, It’s significant
Any equity interest = Its significant
Service in positions with fiduciary responsibility. This includes executive positions, senior management, or membership on boards of directors; and
Reimbursed or sponsored travel.
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16. Investigator Responsibilities Disclosure
Significant Financial Interest
A financial interest that is held: (1) by an individual or a member an individual’s immediate family; or (2) by a business entity that is controlled or directed by an individual or a member of an individual’s immediate family.
Related to the individual’s institutional responsibilities.
Entity Type:
Publically traded company:
Payment + Equity ≥ $5,000, It’s significant
Non-publically traded company:
Payments ≥ $5,000, It’s significant
Any equity interest = Its significant
Service in positions with fiduciary responsibility; Its significant. This includes executive positions, senior management, or membership on boards of directors.
Intellectual property rights and interests (e.g., patents, copyrights, and royalties from such rights)
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17. Investigator Responsibilities Disclosure
Additional disclosure resource
UW-Madison developed a table of common reportable and non-reportable financial interests.
This table can be accessed via this link:
located in section 1.3 “What to Report”
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18. Institutional Responsibilities Evaluation of SFI
Office of Sponsored Programs will preform a cursory review of disclosure.
If a significant financial interest is disclosed, the Provost (Institutional Official for Research) will conduct a review to determine if a possible FCOI exists.
If so, an Ad Hoc Research Responsibility Committee is formed to:
Verify that an FCOI exists and
Recommend a management plan
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19. Institutional Responsibilities Management Plan
If a FCOI exists, committee will recommend a management plan to manage, reduce, or eliminate the COI.
Key elements that have to be addressed in a management plan:
Publication and presentation disclosure.
Disclosure to students, staff and co-investigators.
Cannot have oversight of any purchases from outside entity.
Complete annual review of management plan with Department Chair and/or Dean.
The investigator must agree to the management plan before research can move forward.
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20. Institutional Responsibilities Reporting
If a FCOI is found to exist, the institution must report back to the granting agency.
Elements of this report must include:
Name of PD/PI
Name of Investigator with the FCOI
Name of the entity with which the Investigator has a FCOI
Value of the financial interest
Nature of FCOI, e.g., equity, consulting fees, honoraria
A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
Key elements of the Institution’s management plan
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21. Institutional Responsibilities Monitoring & Non-compliance
Investigators with federal funding must submit an annual disclosure, at a minimum.
If an Investigator submits and ad-hoc disclosure, the institution will review the SFI within 60 days and determine if a FCOI truly exists.
Compliance with management plans will be monitored. If a non-compliance is found…
Institution will report to the agency.
Institution may suspend all relevant activities and/or take disciplinary action.
Research Responsibility Committee will complete a Retrospective Review to determine if the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research.
If bias is determined during the Retrospective Review, the Institutional Official will create an action plan and update any reports as required by the funding agency.
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22. FCOI Process on Sponsored Projects
When submitting a new proposal, all ‘investigators’ need to complete a financial disclosure from.
Must be submitted to Sponsored Programs with proposal
Completion and documentation of the CITI training is also required at that time
Disclosures are reviewed by Institutional Official for Research (Provost)
If it is determined that no FCOI exists, no further action is necessary
If FCOI appears to exist, Research Responsibility Committee reviews disclosures
A management plan is crafted to manage, reduce or eliminate FCOI
If proposal is funded, UWO will report the applicable FCOIs to the funding agency
Award is set-up when all FCOI requirements are completed
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23. FCOI Process on Sponsored Projects
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24. FCOI Requirements for Non-Federal Funding
Some non-federal sponsors have applied the federal regulations to their award terms and conditions.
The FDP maintains a list of these non-federal entities:
Just because its non-federal funding doesn’t mean you are exempt from these requirements.
Review each funding announcement for FCOI requirements.

25. FCOI on Subawards
If receiving a sub-award where the primary sponsor is a federal entity, federal FCOI requirement do apply.
Same requirements and process as if we were receiving the funding directly from the federal agency.
If issuing an outgoing sub-award, its UWO’s responsibility to ensure that the subrecipient has/does:
An up to date FCOI policy that is in compliance with the FCOI regulations
If they don’t, they can agree to use UWO’s policy and process.
If they determine an FCOI exists, with the subrecipient investigator(s), they must report that to UWO.
Its then UWO’s responsibility to report back to the federal funding agency
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26. Questions?
Kurt McMillen Interim Assistant Director, Grants & Proposals Office of Research & Sponsored Programs University of Wisconsin – Madison Kelly Schill Associate Director of Research Compliance Office of Sponsored Programs University of Wisconsin Oshkosh
1/1/2019