FCOI Policy for Extramural Sponsored Projects

1. Financial conflict of interest (FCOI): A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of funded research
2. Immediate family: Refers to the investigator's relations as defined by federal FCOI regulations (42 CFR Part 50, Subpart F), which state that a significant financial interest (SFI) must be disclosed when it is held by an investigator and/or "an investigator's spouse and dependent children." For the purposes of this FCOI policy, at minimum, "spouse" and "dependent children" refer to the terms as presently defined by the Internal Revenue Service (IRS).
3. Investigator: Any individual responsible for the design, conduct, or reporting of research proposed to or funded by a federal sponsor. This always includes all principal investigators (PIs)/project directors (PDs), co-investigators, and senior/key personnel from all participating institutions. It may also include graduate students, undergraduate students, and other collaborators. For help in determining whether an individual meets the definition of an investigator, please refer to the FCOI: Identifying Investigators guidance document.
4. Public Health Service (PHS): The Public Health Service (PHS) of the US Department of Health and Human Services (HHS) and any awarding components of the PHS to which the authority involved may be delegated, including but not limited to agencies such as the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources & Services Administration (HRSA), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
5. Research company: An entity engaged in commercial or nonprofit activity that is related to research conducted by an employee or officer of the UW System or to a product of such research, as defined by Wis. Stat. § 946.13.
6. Significant financial interest (SFI): Remuneration and equity interests of an investigator and/or investigator's immediate family (valued alone or in aggregate) that are listed in the table below and are related to the investigator’s institutional responsibilities (e.g., consulting, research, teaching, writing), field of professional interest, or the sponsored project:

Items that are not considered SFIs, and thus do not need to be reported, include:

1. Payments or equity interests not related to the investigator’s institutional responsibilities, field of professional interest, or the sponsored project
2. Salary, royalties, or other payments from the investigator’s institution, including intellectual property rights assigned to the university and agreements to share in royalties related to such rights
3. Income from investment vehicles (e.g., mutual funds, retirement accounts) so long as the investigator does not directly control the investment decisions made in these vehicles
4. Income from seminars, lectures, or teaching engagements sponsored by US public or non-profit organizations
5. Income from service on advisory committees or review panels for US public or non-profit organizations
6. Any equity interests in an organization that is applying to an SBIR or STTR program (if the investigator is disclosing SFIs for the same proposal)

All investigators on proposals to or awards from any federal sponsor must complete a Significant Financial Interest (SFI) Disclosure Form before an application can be submitted or, in the case of new investigators joining a project already underway, before they begin work on a federal sponsored project. Investigators on proposals to or awards from any non-federal sponsor with FCOI requirements, or contracts with a research company subject to Wis. Stat. § 946.13, are also subject to this requirement. An investigator is responsible for disclosing all of their SFIs (and those of their immediate family) that meet the definitions in this policy (valued alone or in aggregate) that would reasonably appear to be related to the investigator's institutional responsibilities, field of professional interest, or the sponsored project. SFIs are reported through the online SFI Disclosure Form, which must be completed before a proposal can be submitted or, for new investigators joining a project already underway, before an investigator can begin work on a project. Investigators are responsible for disclosing the following information:

1. Remuneration from US business(es)/organization(s) for outside activities related to investigator's institutional responsibilities, field of professional interest, or the sponsored project
   • Name of business/organization associated with the SFI
   • Type of activity (e.g., consulting, research, teaching, writing)
   • Value or estimated value (in USD)
2. Remuneration from a non-governmental US sponsor of university research, teaching, or training for which investigator or a member of their immediate family is an investigator
   • Sponsor name
   • Value or estimated value (in USD)
3. Equity/ownership interests in a US business/organization related to investigator's institutional responsibilities, field of professional interest, or the sponsored project
   • Name of business/organization
   • Present market value or estimated value (in USD)
   • Percentage interest
4. Intellectual property rights & interests
   • Name of rights or interests
5. Travel support
   • Entity providing reimbursement or sponsorship
   • Country of entity’s headquarters
   • Purpose of the trip
   • Destination
   • Duration
   • Value or estimated value received (in USD)
6. Remuneration from a foreign entity related to investigator's institutional responsibilities, field of professional interest, or the sponsored project
   • Name of business/organization associated with the SFI
   • City & country of headquarters
   • Type of activity (e.g., consulting, research, teaching, writing)
   • Value or estimated value (in USD)
7. Financial interests in a foreign entity related to investigator's institutional responsibilities, field of professional interest, or the sponsored project
   • Name of business/organization
   • City & country of headquarters
   • Present market value or estimated value (in USD)
   • Percentage interest

In determining the value of SFIs, investigators should aggregate the values of payments received or equity held by themselves as individuals in addition to those received or held by their immediate family members. Investigators should use standard financial documents to establish the present market value or estimated value in US dollars (USD) of financial interests in determining SFIs that need to be disclosed. For example, this may include, but is not limited to, recent account statements, pay statements, W-2s, 1099s, reimbursement documentation, service contracts, equity documents, stock certificates, purchase agreements, articles of incorporation, balance sheets, income statements, cash flow statements, tax returns, and license agreements. Investigators may be asked to provide copies of such documents to ORSP and the UWL FCOI Committee to substantiate valuations and aid the review process. To calculate the values of financial interests involving foreign entities, investigators should use the OANDA currency converter to establish the values in USD: https://www1.oanda.com/currency/converter/. Use an exchange rate for a date within two weeks of the SFI Disclosure Form submission date.

The SFI Disclosure Form must be completed and signed by the investigator. It is then routed to the UWL Office of Research & Sponsored Programs (ORSP). This process must be completed before the proposal for funding is submitted. Thereafter during the period of the award, an updated SFI Disclosure Form must be submitted to ORSP annually by June 30 and within 30 days of when new SFIs are discovered or acquired. Subsequent SFI Disclosure Forms should disclose newly acquired SFIs and should provide updated information regarding any previously disclosed SFIs (e.g., the updated value of a previously disclosed equity/ownership interest).

Investigator(s) who are new to participating in an ongoing sponsored project must also complete the SFI disclosure process described above. Before a new investigator may begin work on the project, the SFI Disclosure Form must be completed, submitted to ORSP, and reviewed to determine whether a potential FCOI may exist. If a potential FCOI is identified, the review process described below must be completed and a FCOI Management Plan implemented before a new investigator may begin work on the project.

Mississippi Valley Archaeology Center (MVAC) SFI Disclosures: Due to a high volume of research contract activity within MVAC, MVAC investigators engaged in research contract work will complete an SFI Disclosure Form annually by June 30 for all current and anticipated contracts with research companies. The annual disclosure will be submitted in lieu of a separate disclosure for each individual contract. Thereafter, an updated SFI Disclosure Form must be submitted to ORSP within 30 days of when new SFIs are discovered or acquired.

In accordance with federal regulations (42 CFR Part 50, Subpart F), all UWL investigators applying to or receiving awards from a Public Health Service (PHS) agency must successfully complete the institutional FCOI training course and assessment (with a score of at least 80%) in Canvas before an application is submitted to the funding agency. Thereafter, training must be completed every four years. Examples of PHS agencies include, but are not limited to, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources & Services Administration (HRSA), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SMHSA). See the PHS website for a full list of agencies. The training requirement also applies to non-PHS agencies that follow the PHS regulations (e.g., American Heart Association, American Cancer Society).

The training course provides instruction regarding FCOI regulations, UWL's FCOI policy, and investigators' SFI disclosure responsibilities and other obligations related to the policy. Completion of the FCOI training requirement is satisfied by achieving a score of 80% or higher in the course's assessment. Individuals may take the assessment an unlimited number of times. Canvas documents satisfactory completion of the module. Training records are maintained by the Office of Research & Sponsored Programs in accordance with the requirements of the Wisconsin Open Records Law (State Statutes 19.31 through 19.39) and FCOI regulations (42 CFR Part 50, Subpart F).

Additionally, under the following circumstances, training must be completed by investigators working on projects subject to PHS FCOI regulations within 30 days of the occurrence:

1. The university revises its FCOI policy or procedures in any manner that affects the requirements of investigators
2. When an investigator newly affiliated with UWL has an existing sponsored project they will be transferring to and continuing work on at UWL
3. When a new investigator begins work on an ongoing sponsored project at UWL
4. The university finds that an investigator is not in compliance with the university's FCOI policy or a prescribed FCOI Management Plan

Incoming subawards (i.e., UWL is the subrecipient): UWL employees serving as investigators for projects subject to FCOI requirements and led by other institutions are subject to UWL's FCOI policy. UWL has certified its compliance with federal FCOI regulations via the publicly searchable FDP FCOI Clearinghouse: http://thefdp.org/default/fcoi-clearinghouse/compliant-entities/. If additional certification is required by the lead institution, investigators should contact the UWL Office of Research & Sponsored Programs (ORSP) to request documentation.

Outgoing subawards (i.e., UWL is the lead institution): When a project subject to FCOI requirements for which UWL is the lead institution includes an external investigator (whose primary affiliation is with an entity other than UWL), the external investigator is also subject to FCOI regulations. To ensure compliance, an authorized organizational representative (AOR) of the external institution must certify in writing whether the external investigator(s) will follow UWL's FCOI policy or the compliant FCOI policy of the external institution. If the external institution's FCOI policy will apply, the certification must verify that the policy complies with the applicable federal FCOI regulations and/or indicate if the institution is listed in the FDP FCOI Clearinghouse. If needed, a template for this certification is available upon request from ORSP. The certification must be signed by the external institution's AOR. UWL’s subrecipient commitment form or subrecipient letter of intent template can be used for this purpose.

External investigators who are subject to UWL's FCOI policy must fulfill all requirements for UWL investigators as described in this policy – e.g., completion of the SFI Disclosure Form and FCOI training and assessment for the project subject to Public Health Service (PHS) FCOI regulations.

For external investigators who are subject to their affiliated institution's FCOI policy, external institutions must report all identified FCOIs to the UWL ORSP as soon as possible following internal review of disclosed SFIs and prior to the expenditure of funds. Early reporting will help to ensure timely commencement of funding following a notice of award. For subsequently identified FCOIs, external institutions must provide a FCOI report to UWL within 30 days of when a new FCOI is discovered or acquired. FCOI reports made to UWL for external investigators must include the following information:

1. Name of the entity with which the investigator has a FCOI
2. Nature of the FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria)
3. Value or estimated value of the financial interest
4. Description of how the financial interest relates to federally funded research and the basis for the determination that it conflicts with the research
5. Key elements of the management plan
   • Role and principal duties of investigator in the research project
   • Conditions of the management plan
   • How the management plan will safeguard objectivity in the research project
   • Confirmation of the investigator's agreement to the management plan
   • How the management plan will be monitored to ensure compliance
   • Other pertinent information

In the event an external investigator has a FCOI to report, UWL will provide a FCOI report with the above information to the applicable sponsor prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

Once a SFI Disclosure Form is submitted, if any SFIs are disclosed, the form is then reviewed by the Associate Vice Chancellor for Academic Affairs who determines whether a potential FCOI may exist. Forms with no disclosures will be filed in the Office of Research & Sponsored Programs (ORSP) with no further review required. If the Associate Vice Chancellor determines there is a potential FCOI, a FCOI committee will be convened that is comprised of the following members:

1. Associate Vice Chancellor for Academic Affairs
2. Dean or appointed designee of College of Business Administration
3. Dean or appointed designee of College of Arts, Social Sciences, & Humanities
4. Dean or appointed designee of College of Science and Health
5. Dean or appointed designee of School of Education
6. Human resources representative (as a non-voting member acting in an advisory capacity)

Prior to initial committee service, all voting committee members will have successfully completed the UWL FCOI training course and assessment within the past four years. The voting members should begin the initial meeting by selecting a chair who is a voting member. The FCOI committee will determine whether a FCOI exists. If a FCOI is identified, the committee will develop a plan to manage, reduce, or eliminate each conflict using the FCOI Management Plan Form. Investigators may be invited to participate in their FCOI Management Plan development process. In reviewing potential FCOIs, the FCOI committee will be guided by the committee operating guidelines and will accomplish the following:

1. Assure adherence to relevant state law and university policies, including but not limited to the Unclassified Staff Code of Ethics (Chapter UWS 8), including Outside Activities and Interest (UWS 8.025 and UWL 8.025), Standards of Conduct (UWS 8.023 and UWL 8.023), and Action to Avoid Possible Conflict (UWS 8.04 and UWL 8.04); Wis. Stat. § 946.13; and UW System Policy 13-6: Contracts with Research Companies.
2. Consider the nature and extent of the financial interests in the relationship of the investigator and their immediate family and the external organization.
3. Give special consideration to the terms and conditions of sponsored project agreements that may mitigate or complicate the given situation.
4. Consult with and obtain information from the investigator as either the FCOI committee or the investigator feels may be helpful in resolving actual or potential conflicts.
5. Act in a timely manner so as not to delay unduly the conduct of a sponsored project.
6. Determine whether the SFI is related to the sponsored project research. If so, the committee will determine if a FCOI exists (i.e., whether the SFI could directly and significantly affect that design, conduct, or reporting of the sponsored project).
7. If a FCOI is identified, the committee will develop and document a FCOI Management Plan to appropriately manage, reduce, or eliminate the conflict.

Any substantive actions and/or determinations require the majority support of the committee per the committee operating guidelines. All committee meetings will begin in open session and then move into closed session to discuss personal financial matters in accordance with Wisconsin Public Records Law (Wis. Stat. §§ 19.31-19.39). Following FCOI Management Plan development, the plan will be signed by the investigator to indicate their acceptance of the prescribed plan or their intent to appeal to the Chancellor.

Based on the outcomes of the FCOI Management Plan development process, the university may take one of the following actions:

1. Accept the award
2. Not accept the award
3. Accept the award subject to the prescribed actions/modifications prescribed in the FCOI Management Plan

The SFI review and FCOI Management Plan development and approval will be completed before the university's acceptance of the award and commencement of funding. Whenever, during the course of an ongoing sponsored project, an investigator discloses a new SFI, the review process described above will take place within 60 days of the disclosure. Depending on the nature of the SFI, the university may determine that interim measures are necessary regarding the investigator's participation in the sponsored project between the date of disclosure and the completion of the review process.

In the event a satisfactory FCOI Management Plan cannot be developed and approved by all parties, it is UWL’s policy that the associated award will not be accepted. In such an occurrence, ORSP will promptly notify the sponsor of the declined award and provide any required supporting documentation.

After a FCOI Management Plan is developed and approved by all parties, UWL will provide a FCOI report to the sponsor with the following information prior to the expenditure of funds:

1. Project number
2. Principal investigator (PI)/project director (PD) or designated contact in the case of multiple PIs/PDs
3. Name of the investigator with the FCOI
4. Name of the entity with which the investigator has a FCOI
5. Nature of the FCOI (e.g., equity, consulting fees, travel reimbursement, honorarium)
6. Value of the financial interest or statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value
7. Description of how the financial interest relates to sponsored project and the basis for the determination that it conflicts with the project
8. Description of the key elements of the management plan:
   • Role and principal duties of investigator in the project
   • Conditions of the management plan
   • How the management plan will safeguard objectivity in the project
   • Confirmation of the investigator's agreement to the management plan
   • How the management plan will be monitored to ensure compliance
   • Other pertinent information as needed

Following the submission of the initial FCOI report, UWL will provide annual and, when necessary, revised reports to the sponsor regarding the status of the FCOI (i.e., whether the FCOI is still being managed or to explain why the FCOI no longer exists) and changes to the management plan. Annual FCOI reports will be provided to the sponsor concurrently with annual progress reports and at the time of a requested extension (if applicable). In the event of any subsequently identified FCOI held by existing investigators or by new investigators joining an ongoing sponsored project, the university will provide a FCOI report to the sponsor within 60 days of when the FCOI is identified. If a retrospective review is conducted, at the review's conclusion, UWL will provide the sponsor with an updated FCOI report.

For the reporting responsibilities required of external institutions and investigators, please refer to the "External Investigator Requirements" section of this policy. In the case of external investigators who have an identified FCOI, both those subject to the external institution's FCOI policy and those subject to UWL's FCOI policy, UWL will provide the sponsor with a FCOI report prior to the expenditure of funds and within 60 days of subsequently identified FCOIs.

Compliance with a prescribed FCOI Management Plan will be monitored in an immediate and ongoing manner. Following the completion of action(s) described within a FCOI Management Plan, the investigator will notify the Office of Research & Sponsored Programs (ORSP) via email of the action(s)' completion. The prescribed actions and notification must be completed before the sponsored project begins. Additionally, an investigator will certify their ongoing compliance with a prescribed FCOI Management Plan in revisions and annual updates of their SFI Disclosure Form.

Examples of noncompliance with the FCOI policy may include but are not limited to failure by an investigator to disclose a SFI in accordance with policy guidelines or failure to comply with a FCOI Management Plan. In the event noncompliance is identified, the investigator will be expected to cooperate with university efforts to resolve the noncompliance. Upon determination of noncompliance with the university's FCOI policy, the sponsor will be promptly notified.

SFIs that are not disclosed in a timely manner will be evaluated to determine whether the SFI is a FCOI. The SFI review process will be completed within 60 days of when the previously undisclosed SFI is discovered. Depending on the nature of the potential FCOI, the university may determine that additional interim measures are necessary regarding the investigator's participation in the sponsored project between the date that the potential FCOI is determined and the completion of the evaluation process and possible retrospective review (as described below). If the FCOI committee determines an investigator's FCOI may have biased the design, conduct, or reporting of the funded research, the university will promptly notify the sponsor of the corrective action taken or to be taken.

If a FCOI is identified during the above review process or an investigator is found to be noncompliant with a prescribed FCOI Management Plan for an ongoing sponsored project, within 120 days of the determination, a retrospective review will be completed by the university:

1. The FCOI committee will be convened.
2. The FCOI committee will complete a retrospective review of the investigator's activities and the sponsored project to determine whether any sponsored activities, or portion thereof, conducted during the period of the investigator's noncompliance was biased in the design, conduct, or reporting of such activities.
3. The committee will document the following information during the retrospective review:
   • Project number
   • Project title
   • Principal investigator (PI)/project director (PD) (or primary PI/PD if multiple PIs/PDs are noted)
   • Name of the investigator with the FCOI
   • Name of the entity with which the investigator has a FCOI
   • Reason(s) for the retrospective review
   • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
   • Findings of the review (i.e., facts and observations)
   • Conclusions of the review (i.e., determination and recommended actions)
4. If bias is found during the retrospective review, the university will promptly notify the sponsor. Additionally, the committee will complete a mitigation report, which will be submitted to the sponsor. The mitigation report will address the following elements:
   • Key elements documented during the retrospective review
   • Description of the impact of the bias on the project
   • University's plan of action(s) taken to eliminate or mitigate the effect of the bias (i.e., impact on the project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the project is salvageable)
5. Thereafter, the university will submit FCOI reports to the sponsor annually.
6. Depending on the nature of the noncompliance, the university may determine that additional interim measures are necessary with regard to the investigator's participation in the sponsored project between the date that the noncompliance is determined and the completion of the retrospective review.

Investigators have the right to appeal the findings and decisions of the FCOI committee according to the procedures described in the Appeals section of this policy.

Additional sanctions will apply to violations of the policy by investigators conducting clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment. Such investigators who have a FCOI that was not managed or reported in a timely manner according to the guidelines of this policy will be required to disclose the FCOI in each public presentation of the research results. For previously published presentations, investigators will be required to request an addendum to disclose the FCOI.

If noncompliance with this policy is determined, then an investigator may be required to complete additional training, research funding can be withheld, and/or other appropriate enforcement mechanisms (including suspension/termination of employment) can be recommended to the appropriate university administrator. Per Section B: Code of Ethics in the UWL Employee Handbook, "Employees have responsibilities under the Wisconsin Code of Ethics and UW System Chapter 8 Unclassified Staff Code of Ethics. […]  Violation of any provision under the Code of Ethics could result in disciplinary action, up to and including termination." Additionally, an investigator may be subject to sanctions and penalties imposed or directed by the sponsor in accordance with applicable FCOI regulations (e.g., 42 CFR Part 50 Subpart F, NIH Grants Policy Statement Chapter 8.5 Special Award Conditions and Enforcement Actions, NSF PAPPG), other applicable federal regulations (e.g., 45 CFR parts 74.61, 74.62, and 92.43), and state regulations (e.g., Wis. Stat. § 946.13). Depending on the severity and duration of the noncompliance, in addition to actions taken by the university, the sponsor may take actions including but not limited to the following: imposing special conditions on an award to allow the investigator to take corrective action, action to wholly or partly suspend the award pending corrective action, or termination of the award.

If the investigator is dissatisfied with the outcomes of a prescribed FCOI Management Plan, retrospective review findings, or prescribed mitigation report, within 30 days, the investigator may make a written appeal to the Chancellor, also directing a copy of the appeal to the Associate Vice Chancellor for Academic Affairs. The Chancellor will consult with the investigator and the FCOI committee as deemed necessary and appropriate to the particular circumstances. The decision of the Chancellor upon appeal shall be final.

The Office of Research & Sponsored Programs shall maintain all FCOI-related records as follows:

1. Grants or cooperative agreements: for four years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42(b) for different situations; or five years following the resolution of any agency action involving the associated records (whichever period is longer)
2. Research contracts: for four years after final payment or, where applicable, for other time periods specified in 48 CFR Part 4, subpart 4.7; or five years following the resolution of any agency action involving the associated records (whichever period is longer)

The Office of Research & Sponsored Programs shall maintain records pertaining to each financial disclosure in accordance with the requirements of the Wisconsin Open Records Law, State Statutes 19.31 through 19.39. In accordance with federal FCOI regulations, information concerning identified significant financial interests (SFIs) held by investigators will be publicly accessible via written request if the interests meet all of the following criteria:

1. The SFI was disclosed and is still held by the investigator for the sponsored project identified by UWL in the application, progress report, or any other required report submitted to the sponsor.
2. UWL determines that the SFI is related to the sponsored project.
3. UWL determines that the SFI is a financial conflict of interest (FCOI).

To obtain information concerning a SFI that meets all of the above criteria, a written request should be submitted to the UWL Assistant to the Vice Chancellor for Administration and Finance. The information will be made available within five business days of such a request and will include the following information:

1. Investigator's name
2. Investigator's title and role with respect to the sponsored project
3. Name of the entity in which the SFI is held
4. Nature of the SFI
5. Approximate dollar value of the SFI (with the exception of interests whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value)

In the case of external investigators who are required to comply with an external institution's FCOI policy, the external institution will be responsible for making SFI information for its affiliated investigators publicly available in accordance with federal FCOI regulations. If external investigators are required to comply with UWL's FCOI policy, identified SFI information is subject to UWL's policy on public accessibility. Information described above will remain publicly available for three years from the date the information was most recently updated.