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Conflict of Interest

Introduction

Faculty and staff are encouraged to participate in outside activities, share expertise, and transfer intellectual property to the private sector. Sometimes, your participation in outside activities may generate conflicts between the needs of the institution and the outside entity. UW-Green Bay understands that these conflicts are common, frequently unavoidable, and can often be appropriately managed. To avoid or appropriately manage any potential conflicts of interest (COI) when the outside activities or collaborations are funded with extramural funds, Universities of Wisconsin, the federal government, and UW-Green Bay have policies and procedures that project key personnel must follow.

Overview of Requirements

  1. Policies of the University of Wisconsin Board of Regents, federal government, and UW-Green Bay require disclosure of all outside activities related to your institutional responsibilities. All faculty, regardless of appointment, all academic staff with 50% or greater appointment, and all individuals listed as participants on human subject protocols or on federal grants are required to fill out an annual Outside Activities and Interests Form and update whenever new outside activities are undertaken.
  2. In practice, all project key personnel employed at UW-Green Bay who are submitting proposals through the OGR, federal or otherwise, need to complete the Collaborative Institutional Training Initiative (CITI) COI training on an interval of no less frequently than once every four years. Key personnel are defined as those individuals essential to the project who would be named in the agency Notice of Grant Award.
  3. In practice, all key personnel on federal grant submissions must have a completed and signed the Outside Activities and Interests Form.

UW-Green Bay Compliance Guidelines for Contracts with Research Companies and Financial Conflicts of Interest

UW-Green Bay faculty and staff are encouraged to participate in outside activities, share expertise, and transfer intellectual property to the private sector. As a result of this engagement conflicts of interest may arise. UW-Green Bay understands that these conflicts are common, frequently unavoidable, and can be appropriately managed. These conflicts are particularly common in sponsored programs, such as research and fee for service agreements, where funds are received for work or services provided.  To avoid, remediate, and appropriately manage any conflicts of interest, the Universities of Wisconsin, the federal government, and UW-Green Bay have policies and procedures that personnel must follow.

Any University employee who, within the scope of his or her work, contracts with any organization in the private sector, must be aware and adhere to the following requirements:

  1. Reporting of outside activities. The University employee must submit annual and updated reports of outside activities consistent with institutional requirements and processes.
  2. Use of University facilities and services. Any activity involving the use of University facilities or services for the benefit of a third-party company (e.g., a research company or organization) must be conducted in accordance with all institutional and system policies and state and federal laws pertaining to the use of University facilities and services. Except with respect to use of facilities and services made available for general public use in accordance with established rates and conditions applicable to all users, any such activity must be approved by the University and an approved contract is required before the activity begins.
  3. Contract negotiation, approval and signature. The University employee may not negotiate or sign any contract with a third-party company on behalf of their institution. In addition, any such contract’s terms and budget must be approved by the University.
  4. Invoicing and billing. The University employee may not be responsible for invoicing or billing the third-party company, nor for institutional decision-making should any issue regarding the third-party company’s performance under a contract.
  5. Purchases. The University employee may not be directly involved in decision-making involving the purchase of items or services from the third-party company. Any such decisions must be made by an impartial party, and accordingly, any such purchases from the third-party company must be referred to the Purchasing Office.

If I am working with an Outside Agency in the Private Sector, what are my Obligations?

Policies of the University of Wisconsin Board of Regents, federal government, and UWGB require disclosure of all outside activities related to your institutional responsibilities. All faculty, regardless of appointment, all academic staff with 50% or greater appointment, and all individuals listed as participants on human subject protocols or on federal grants are required to fill out an annual Outside Activity Report.

In addition to that annual requirement, employees who submit federal or non-federal sponsored work proposals through the Office of Grants and Research and are essential to the project and named in the agency Notice of Grant Award must complete the Collaborative Institutional Training Initiative (CITI) COI training not less than once every four years.

UW-Green Bay understands that in business transactions where sec. 946.13 Wis. Stats. may apply, elements of the agreement must be reviewed. UW-Green Bay further understands there may be occasions where a necessary employee may be required to enter into a management plan issued by the OGR and confirmed by University Administration. In matters where the combination of: the outside organization, the work being performed by the employee with that organization, and research or deliverable creates a potential conflict of interest, it should be reported to the Office of Grants and Research for further review.

Review:

What is reviewed?

All investigators are required to submit an Outside Activity Report within the Universities of Wisconsin. An evaluation will be done at that time to identify any business for which the reporter has a “significant” financial interest. It is the responsibility of the employee to identify any financial interest they may have in a research project for which they have a significant financial interest.

What is a Significant Financial Interest (SFI)?

Financial interests and research projects become associated when a University employee has a personal financial interest (personal compensation, royalties, ownership, fiduciary duty, etc.) in an organization or company that also seeks to sponsor research at the University. If a significant financial interest is determined to exist, the Office of Grants and Research must determine if it intersects directly with a research project. When these two circumstances converge, then a financial conflict of interest in research is created. 42 CFR 50.603

The below listed interests in an organization by the employee, their spouse or their dependent children, constitute an SFI:

  • For publicly traded entities:
    • The value of remuneration received from an entity in the twelve months preceding disclosure, in combination with the value of any equity interest in the company as of the date of disclosure, equals $5,000 or more;
  • For non-publicly traded entities:
    • The value of any remuneration received from the entity in the twelve months preceding disclosure equals $5,000 or more;
    • Any equity interest in the company;
  • Any income from intellectual property rights that are not assigned to UW-Green Bay;
  • Service in positions with fiduciary responsibility. This includes executive positions, senior management positions, or membership on boards of directors; and
  • For those that receive federal funding, reimbursed or sponsored travel.

Who does the reviewing?

When a possible conflict is identified, the employee should report the possible conflict to the Office of Grants and Research (OGR). The OGR is responsible for reviewing disclosure reports and determining all instances of significant financial interest. If a conflict is confirmed, the OGR will provide additional processes to determine whether the conflict will prevent the agreement from being completed.

Review of SFIs

If an activity meets the definition of a SFI, the OGR will next make a recommendation that the matter requires or does not require a management plan. If a management plan is required, a staff member will review the reported activity to:

  • Determine whether there is a nexus between an investigator's research and the significant financial interest. A significant financial interest is a financial conflict of interest if the interest could directly and significantly affect the design, conduct, or reporting of research;
  • Determine whether a financial conflict of interest (FCOI) exists; and
  • Discuss possible management plans to mitigate any conflict of interest under applicable policy.

Management Plans

If it is determined that the employee's financial interests constitute a conflict of interest, a management plan will be developed for the employee by the OGR to minimize or eliminate the conflict. The employee will receive notice from the OGR with further instructions if a management plan is assigned.

If a management plan is implemented:

The employee is responsible for all of its terms and conditions and must cooperate with the University's efforts to monitor compliance with the management plan. Additionally, if the program is subject to IRB review, the employee must inform the IRB of any changes or updates to the management plan(s). Funding that is related to a management plan will not be available for spending until the employee has electronically accepted the management plan.

Retrospective Review

If an employee does not report a significant financial interest in a timely manner or if a conflict is discovered after the work has begun, a retrospective assessment of financial interests will still need to occur to determine if there is a conflict of interest. The retrospective review must determine whether any work conducted during the period of noncompliance was biased in its design, conduct, or reporting.

If the retrospective review determines possible conflict or bias, the OGR will notify the sponsor of its findings, along with a mitigation report that includes: (1) the key elements documented in the retrospective review; (2) a description of the impact of the bias on the research project; and (3) UW–Green Bay’s plan of action for eliminating and mitigating the effects of the bias.

References and Resources

42 CFR 50.603
UW-Green Bay Faculty Handbook
UWSA Conflict of Interest and Outside Activities
RPD 13-6
UWS 8 Wis.Adm.Code.