Financial Conflict of Interest (FCOI)

I. Policy

Consistent with federal regulations, beginning on August 24, 2012, all faculty and academic staff at the University of Wisconsin-Eau Claire who plan to participate in, or are participating in, Public Health Service (PHS)-funded research must fully disclose potential financial conflicts of interest and successfully complete financial conflict of interest training. The purpose of this policy is to comply with PHS regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). These regulations promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest.

II. Procedures

A.  Disclosure
According to the National Institutes of Health, a potential financial conflict of interest exists when an investigator has significant financial interests 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 to the individual or his or her immediate family (i.e., spouse and dependent children). As a result, all faculty and academic staff who plan to participate in, or are participating in, PHS-funded research must submit a Financial Conflicts of Interest Disclosure Form no later than at the time of application, within 30 days of discovering or acquiring a new significant financial interest, and at least annually during the period of award.

Examples of significant financial interests that must be disclosed include the following:

• When the value of any remuneration received from an entity in the twelve months preceding the disclosure and the value of any equity interest (e.g., stocks, stock options, or ownership interests) in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
• When any equity interest in a non-publicly traded entity is held.
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
• Any reimbursed or sponsored travel (i.e., paid by an outside entity directly to a provider on behalf of the investigator) that is related to institutional responsibilities.

Significant financial interests do not include the following types of financial interests:

• Salary, royalties, or other remuneration paid by UW-Eau Claire to the investigator if the investigator is currently employed or otherwise appointed by UW-Eau Claire, including intellectual property rights assigned to UW-Eau Claire and agreements to share in royalties related to such rights;
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;
• Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 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 at 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.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to PHS-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a management plan, including appropriate compliance monitoring.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, including discipline, loss of privilege to serve as an investigator on PHS-funded research projects, and dismissal. Instances of noncompliance trigger obligations for UW-Eau Claire to conduct a retrospective review of the research conducted during the period of noncompliance to ensure that it was not biased in its design, conduct, or reporting. If bias is found, the sponsor must be notified and a mitigation report submitted. Financial conflict of interest reports must be submitted annually thereafter.

If the NIH determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an investigator with a financial conflict of interest that was not managed or reported by UW-Eau Claire, the investigator involved will be required to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Information concerning financial conflicts of interest held by investigators will be made accessible consistent with federal regulations. Records relating to all investigator disclosures of financial interests and UW-Eau Claire’s review of, or response to, such disclosures (whether or not a disclosure resulted in a financial conflict of interest determination), and all actions under UW-Eau Claire’s policy or retrospective review, if applicable, will be maintained for at least three years from the date the final expenditures report is submitted.

B. Training
The investigator is responsible for successfully completing financial conflict of interest training on the federal regulation, on disclosure responsibilities, and on this UW-Eau Claire policy prior to engaging in PHS-funded research and at least every four years thereafter. Investigators who come to UW-Eau Claire from other institutions must undergo UW-Eau Claire’s training prior to the expenditure of funds on a PHS-funded research project. Should UW-Eau Claire find that an investigator is not in compliance with the policy or a financial conflict of interest management plan, retraining will be necessary. In the event UW-Eau Claire revises its financial conflict of interest policy and procedures in any manner that affects the requirements of investigators, retraining will be necessary.

Instructions for completing HSP Training via CITI:

Visit the CITI training website: https://about.citiprogram.org/en/homepage/
Create an account using your UWEC email address
Click "ADD a Course" in the "My Learner Tools for University of Wisconsin-Eau Claire"
Choose the appropriate course-Conflicts of Interest (COI)

Complete all modules required for your course. Successful completion requires a composite score of 80% on the quizzes. Quizzes may be repeated in order to achieve this score. A completion report will be generated when all modules are complete and a composite score of 80% has been achieved.

C. Treatment of Subcontractors, Subrecipients, and Collaborators
When UW-Eau Claire carries out a PHS-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict of interest management and reporting in the agreement between the parties.

Last updated: November 3, 2023

III. Definitions

The PHS regulations provide the following key definitions of terms.

• Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution.
• Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
• FCOI report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.
• Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
• HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
• Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.
• Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
• Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
• Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
• PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
• PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
• PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
• Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
• Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
• Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.

Significant financial interest means:
(1) 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 institutional responsibilities:

(i) With regard to any 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;

(ii) With regard to any non-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, 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); or

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) 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; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 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. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 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; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 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.

The National Science Foundation (NSF) requires the University of Wisconsin-Eau Claire to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced, or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

NSF requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF or in entities whose financial interests would reasonably appear to be affected by such activities. NSF requires UW-Eau Claire to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. Disclosures must be updated during the period of the award, either on an annual basis or as new reportable significant financial interests are obtained.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to NSF-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a plan to manage, reduce or eliminate conflicts of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to: public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in the portion of the NSF-funded research that would be affected by significant financial interests; divestiture of significant financial interests; or severance of relationships that create conflicts.

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, such as discipline, loss of privilege to serve as an investigator on NSF-funded research projects, and dismissal. UW-Eau Claire must keep NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest. Grantee notifications of conflict of interest that cannot be managed, reduced, or eliminated and awardee notifications of situations where research will proceed without the imposition of conditions or restrictions when a conflict of interest exists, must be signed and submitted by the Executive Director for Research via use of NSF’s electronic systems.

UW-Eau Claire must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

Treatment of Subcontractors, Subrecipients, and Collaborators

When UW-Eau Claire carries out a NSF-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict of interest management and reporting on the agreement between the parties.

Last updated: November 3, 2023

The term “investigator” means the principal investigator, co-principal investigators/co-project directors, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.

As specified by NSF, the term “significant financial interest” (SFI) means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term does not include:

·         salary, royalties, or other remuneration from the applicant institution

·         income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities

·         income from service on advisory committees or review panels for public or nonprofit entities

·         an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity

·         salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the twelve month period

NOTE: Although current NSF regulations specify a higher threshold for SFI, UW-Eau Claire policy identifies $5,000 as the monetary threshold. Similarly, in non-publicly traded companies, UW-Eau Claire policy identifies any equity amount as the threshold.

Last Updated: January 2024

The National Aeronautics and Space Administration (NASA) requires the University of Wisconsin-Eau Claire to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced, or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

NASA requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF or in entities whose financial interests would reasonably appear to be affected by such activities. NASA requires UW-Eau Claire to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NASA. Disclosures must be updated during the period of the award, either on an annual basis or as new reportable significant financial interests are obtained.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to NASA-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a plan to manage, reduce or eliminate conflicts of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NASA-funded research or educational activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to: public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in the portion of the NASA-funded research that would be affected by significant financial interests; divestiture of significant financial interests; or severance of relationships that create conflicts.

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, such as discipline, loss of privilege to serve as an investigator on NASA-funded research projects, and dismissal. UW-Eau Claire must keep NASA’s Grant Officer appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest.

UW-Eau Claire must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

Treatment of Subcontractors, Subrecipients, and Collaborators

When UW-Eau Claire carries out a NASA-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict of interest management and reporting on the agreement between the parties. 

See NASA definitions.

For the purposes of section 3.3, the following definitions apply:

The term “conflict of interest,” or “COI,” means a situation in which an investigator, or the investigator’s spouse or dependent children, has a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NASA-funded research.

The term “significant financial interest” means anything of monetary value, including, but not limited to, salary and any payment for services not otherwise identified as salary (e.g., stock, stock options, private equity, or other ownership interest), venture or other capital financing, and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). The term does not include the following:

Salaries, royalties, or other remuneration paid by the proposing institution to the investigator if the investigator is currently employed or otherwise appointed by the institution;

Any ownership interests in the proposing institution if the institution is a commercial or for-profit organization;

Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;

Income from seminars, lectures, or teaching engagements sponsored by a public or nonprofit entity;

Income from service on advisory committees or review panels for a public or nonprofit entity;

An equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: (1) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and (2) does not represent more than a 5 percent ownership interest in any single entity; or

Salaries, royalties, or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the prior twelve-month period.

The term “institution’ means any domestic or foreign, public, or private, entity or organization that is applying for, or that receives, a NASA research grant or cooperative agreement.

The term “investigator” means the principal investigator, project director, and any other person, regardless of title or position, identified on the proposed project who is responsible for the design, conduct, or reporting of research funded or proposed for funding by NASA.

The U.S. Department of Justice (DOJ) awards federal funds and requires the recipients of those funds to use them in the best interest of the award program. The decisions related to the awarded funds must be free of undisclosed personal and organizational conflicts of interest. All faculty and academic staff at the University of Wisconsin-Eau Claire who participate in DOJ funded projects must fully disclose potential financial conflicts of interest and successfully complete financial conflict of interest training. See DOJ Guide Sheet. 

A. Disclosure

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to DOJ-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a plan to manage, reduce or eliminate conflicts of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of DOJ-funded research or educational activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to: public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in the portion of the DOJ-funded research that would be affected by significant financial interests; divestiture of significant financial interests; or severance of relationships that create conflicts.

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, such as discipline, loss of privilege to serve as an investigator on DOJ-funded research projects, and dismissal. UW-Eau Claire must keep DOJ appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest. Grantee notifications of conflict of interest that cannot be managed, reduced, or eliminated and awardee notifications of situations where research will proceed without the imposition of conditions or restrictions when a conflict of interest exists, must be communicated by the Executive Director for Research to DOJ.

UW-Eau Claire must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any DOJ action involving those records, whichever is longer.

B. Training

The investigator is responsible for successfully completing financial conflict of interest training on the federal regulation, on disclosure responsibilities, and on this UW-Eau Claire policy prior to engaging in DOJ-funded research and at least every four years thereafter. Investigators who come to UW-Eau Claire from other institutions must undergo UW-Eau Claire’s training prior to the expenditure of funds on a DOJ-funded research project. Should UW-Eau Claire find that an investigator is not in compliance with the policy or a financial conflict of interest management plan, retraining will be necessary. In the event UW-Eau Claire revises its financial conflict of interest policy and procedures in any manner that affects the requirements of investigators, retraining will be necessary.

Instructions for completing HSP Training via CITI:

Visit the CITI training website: https://about.citiprogram.org/en/homepage/
Create an account using your UWEC email address
Click "ADD a Course" in the "My Learner Tools for University of Wisconsin-Eau Claire"
Choose the appropriate course-Conflicts of Interest (COI)

Complete all modules required for your course. Successful completion requires a composite score of 80% on the quizzes. Quizzes may be repeated in order to achieve this score. A completion report will be generated when all modules are complete and a composite score of 80% has been achieved.

C. Treatment of Subcontractors, Subrecipients, and Collaborators

When UW-Eau Claire carries out a DOJ-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict of interest management and reporting in the agreement between the parties.

See DOJ Guide Sheet. 

The Department of Energy (DOE) requires the University of Wisconsin-Eau Claire to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced, or eliminated prior to the expenditure of the award funds. If an institution conducts agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

These regulations promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under DOE grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest or organizational conflicts of interest.

The Department of Energy (DOE) interim Conflict of Interest Policy and Financial Assistance Letter can be found at https://www.energy.gov/management/financial-assistance-letter-no-fal-2022-02. The applicant is subject to the requirements of the interim COI Policy and within each application for financial assistance, the applicant must certify that it is, or will be by the time of receiving any financial assistance award, compliant with all requirements in the interim COI Policy. The applicant must flow down the requirements of the interim COI Policy to any subrecipient non-Federal entities.

A.  Disclosure
According to the Department of Energy, a potential financial conflict of interest exists when an investigator has significant financial interests 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 to the individual or his or her immediate family (i.e., spouse and dependent children). As a result, all faculty and academic staff who plan to participate in, or are participating in, DOE-funded research must submit a Financial Conflicts of Interest Disclosure Form no later than at the time of application, within 30 days of discovering or acquiring a new significant financial interest, and at least annually during the period of award.

Examples of significant financial interests that must be disclosed include the following:

• When the value of any remuneration received from an entity in the twelve months preceding the disclosure and the value of any equity interest (e.g., stocks, stock options, or ownership interests) in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
• When any equity interest in a non-publicly traded entity is held.
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
• Any reimbursed or sponsored travel (i.e., paid by an outside entity directly to a provider on behalf of the investigator) that is related to institutional responsibilities.

Significant financial interests do not include the following types of financial interests:

• Salary, royalties, or other remuneration paid by UW-Eau Claire to the investigator if the investigator is currently employed or otherwise appointed by UW-Eau Claire, including intellectual property rights assigned to UW-Eau Claire and agreements to share in royalties related to such rights.
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles.
• Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 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 at 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.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to DOE-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a management plan, including appropriate compliance monitoring.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, including discipline, loss of privilege to serve as an investigator on DOE-funded research projects, and dismissal. Instances of noncompliance trigger obligations for UW-Eau Claire to conduct a retrospective review of the research conducted during the period of noncompliance to ensure that it was not biased in its design, conduct, or reporting. If bias is found, the sponsor must be notified, and a mitigation report submitted. Financial conflict of interest reports must be submitted annually thereafter.

Information concerning financial conflicts of interest held by investigators will be made accessible consistent with federal regulations. Records relating to all investigator disclosures of financial interests and UW-Eau Claire’s review of, or response to, such disclosures (whether or not a disclosure resulted in a financial conflict of interest determination), and all actions under UW-Eau Claire’s policy or retrospective review, if applicable, will be maintained for at least three years from the date the final expenditures report is submitted.

B. Training
The investigator is responsible for successfully completing financial conflict of interest training on the federal regulation, on disclosure responsibilities, and on this UW-Eau Claire policy prior to engaging in DOE funded research and at least every four years thereafter. Investigators who come to UW-Eau Claire from other institutions must undergo UW-Eau Claire’s training prior to the expenditure of funds on a PHS-funded research project. Should UW-Eau Claire find that an investigator is not in compliance with the policy or a financial conflict of interest management plan, retraining will be necessary. In the event UW-Eau Claire revises its financial conflict of interest policy and procedures in any manner that affects the requirements of investigators, retraining will be necessary.

Instructions for completing HSP Training via CITI:

Visit the CITI training website: https://about.citiprogram.org/en/homepage/
Create an account using your UWEC email address
Click "ADD a Course" in the "My Learner Tools for University of Wisconsin-Eau Claire"
Choose the appropriate course-Conflicts of Interest (COI)

Complete all modules required for your course. Successful completion requires a composite score of 80% on the quizzes. Quizzes may be repeated in order to achieve this score. A completion report will be generated when all modules are complete and a composite score of 80% has been achieved.

C. Treatment of Subcontractors, Subrecipients, and Collaborators
When UW-Eau Claire conducts a DOE-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict of interest management and reporting on the agreement between the parties.

As used in this Policy can be found in the Department of Energy’s Financial Assistance Letter.

The Department of Education (DOEd) requires the University of Wisconsin-Eau Claire to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced, or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

DOEd requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by the DOEd or in entities whose financial interests would reasonably appear to be affected by such activities. DOEd requires UW-Eau Claire to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to DOEd. Disclosures must be updated during the period of the award, either on an annual basis or as new reportable significant financial interests are obtained.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to DOEd-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a plan to manage, reduce or eliminate conflicts of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of DOEd-funded research or educational activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to: public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in the portion of the DOEd-funded research that would be affected by significant financial interests; divestiture of significant financial interests; or severance of relationships that create conflicts.

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, such as discipline, loss of privilege to serve as an investigator on DOEd-funded research projects, and dismissal.

UW-Eau Claire must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate.

The Environmental Protection Agency (EPA) requires the University of Wisconsin-Eau Claire to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced, or eliminated prior to the expenditure of the award funds. All faculty and academic staff at the University of Wisconsin-Eau Claire who participate in EPA funded projects must fully disclose potential financial conflicts of interest at the time of application. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution. Disclosures must be updated during the period of the award, either on an annual basis or within 10 days of new reportable financial interests are obtained.

Financial Conflicts of Interest Disclosure Forms will be reviewed first by the investigator’s department Chair or equivalent, then by the appropriate Dean or equivalent, and finally by the Executive Director for Research. When reviewing the forms, should a potential or actual conflict be identified, the Executive Director for Research may convene an ad-hoc committee to explore the situation further. The committee will make a recommendation about whether the significant financial interest is related to the investigator’s institutional responsibilities, whether it relates to EPA-funded research, and whether it is a financial conflict of interest. If the committee concludes that a financial conflict of interest exists, they will also make recommendations for development and implementation of a management plan, including appropriate compliance monitoring.

Deliberate misrepresentation of information provided on Financial Conflicts of Interest Disclosure Forms or failure to comply with the terms of this policy may result in sanctions, including discipline, loss of privilege to serve as an investigator on EPA-funded research projects, and dismissal. Instances of noncompliance trigger obligations for UW-Eau Claire to conduct a retrospective review of the research conducted during the period of noncompliance to ensure that it was not biased in its design, conduct, or reporting. If bias is found, the sponsor must be notified, and a mitigation report submitted. Financial conflict of interest reports must be submitted annually thereafter.

Information concerning financial conflicts of interest held by investigators will be made accessible consistent with federal regulations. Records relating to all investigator disclosures of financial interests and UW-Eau Claire’s review of, or response to, such disclosures (whether or not a disclosure resulted in a financial conflict of interest determination), and all actions under UW-Eau Claire’s policy or retrospective review, if applicable, will be maintained for at least three years from the date the final expenditures report is submitted.

Treatment of Subcontractors, Subrecipients, and Collaborators

When UW-Eau Claire carries out an EPA-funded grant or cooperative agreement through subcontractors, subrecipients or collaborators, UW-Eau Claire must take reasonable steps to ensure that the subrecipient investigator is in compliance with federal regulations. UW-Eau Claire fulfills this requirement by setting forth the obligations of each party with respect to conflict-of-interest management and reporting on the agreement between the parties. 

EPA's Financial Assistance Conflict of Interest Policy