Evaluating and Managing Individual Conflict of Interest Disclosures

I. Who Evaluates the Disclosure Forms

1. Review at the Department/Unit Level:

   Chairs, heads, or directors of departments/divisions (unit approvers) typically evaluate Report of External Professional Activities (REPA) forms at the local level. This level of review is optional. Some colleges and administrative units choose to forego local review and have the collegiate or administrative office perform the only level of review of its REPA forms.

   Approval authority at the unit level generally may not be delegated. However, in exceptionally large departments and with the authorization of the responsible Conflict Review Committee (CRC), approval authority for REPA forms may be delegated from a department chair to his or her division heads. This delegation is based on the rationale that each division head would have more personal knowledge of his or her appointees' external activities and interests, and could provide greater oversight of the reporting of these activities and interests and of potential conflicts of interest.

2. Review at the Collegiate Level:

   Review and approval of REPA forms is required at the collegiate level. Different approvers may be involved in the review process depending on the interests reported.

   1. REPAs with No Interests to Report. Approval may be delegated from the dean, vice president, or provost to a 'designated' approver. This delegation is based on the need to process the large numbers of forms received at the collegiate level. Examples of designated collegiate approvers include the associate dean, the senior administrator responsible for the human resources functions of the college or administrative unit, or an executive assistant.
   2. REPAS with Interests to Report. The form is evaluated by the collegiate approver and approved if appropriate (the collegiate approver cannot delegate approval). Where the reported interests present a moderate to high potential for conflict (see situations described under Section VII.B. of Procedure 2.1.16.1, Disclosing Potential Individual Conflicts of Interest), the form is referred to the CRC. Once the CRC has reviewed the REPA and there is an approved plan to manage, reduce, or eliminate the conflict, the collegiate approver may approve the form.

II. Responsibilities of the Approver

The approval process is an opportunity for approvers to perform a local review of activities and interests. Often, the approver has some personal knowledge of the covered individual's external activities and interests and can determine if they were reported fully and accurately. When reviewing the REPA form's data, the approver is responsible for examining the external activities and interests reported and determining if:

• to the best of his or her knowledge, the interests are reported accurately and fully;
• the activities and interests reported either present no potential conflict of interest or represent potential conflicts of interest that have been resolved to the University's satisfaction; and
• the activities comply with University policies on outside commitments and consulting.

To serve as an approver of REPA forms, the unit and collegiate approvers must be set up as 'approvers' in the system. Contact EGMS helpline at (612) 624-1600 for further information.

III. Evaluation of Activities Involving Human Subjects

Research activities involving the participation of human are reviewed with extra scrutiny because of the potential to compromise the welfare of human subjects. Normally, researchers are not permitted to conduct human subjects research at the University when they hold relevant outside financial or business interests related to the research. However, researchers may submit a request to the collegiate approver and the CRC and present the circumstances they believe would justify a departure from this general principle.

IV. Evaluating Forms with No Interests to Report

These forms are reviewed by the unit approver, and if approved, they are sent to the collegiate approver. The collegiate approver can "batch" approve these forms (approve many forms at once).

The unit and collegiate approvers are expected to follow up with the filer if they have questions or believe the information on the form may be inaccurate or incomplete.

V. Evaluating Forms with Reported Interests

1. Activities With a "Minimal To Moderate" Potential for Conflict: These forms are reviewed by the unit approver, and if approved, they are sent to the collegiate approver. The collegiate approver must review each form and, if appropriate, approve it. Collegiate approvers who wish to seek additional administrative review may defer signing a REPA and electronically refer the REPA form to the CRC.

2. The presumption is that these potential conflicts are normally allowable, however the unit and collegiate approvers are expected to follow up with the filer if they have questions or believe the information on the form may be inaccurate or incomplete.

3. Activities With a "Moderate To High" Potential for Conflict:

   These forms are reviewed first by the unit approver and then referred to the collegiate approver. Because of the increased risk of these potential conflicts, each situation requires case-by-case evaluation. Therefore the collegiate approver evaluates the form and refers it to the CRC before it is approved. The collegiate approver may recommend a plan to the CRC to resolve the potential conflict or may rely on the CRC to develop a plan.

   The CRC will review the REPA data for potential conflicts of interests and will obtain input from the individual whose situation is under review before issuing its recommendation. The CRC considers many factors, including the size of the business or significant financial interest, when the relationship commenced, whether the conditions of the relationship have changed during the past year, the likelihood of actual conflict (will the results of the activity likely be compromised by the relevant business or significant financial interest), how closely the University activity is related to the financial or business interest, mechanisms to ensure integrity (peer review, other independent research sites, and independent monitors or controls), the importance of the proposed activity, the participation of human subjects, the availability of alternatives to avoid the conflict or apparent conflict and any other relevant information. The CRC issues its recommendation to the collegiate approver who determines the course of action for handling the proposed conflict.

   Many sponsors require that potential conflicts be reported to them. If so, the Vice President for Research or designee will fulfill these requirements prior to the expenditure of sponsored research funds.

VI. Appeal/Reconsideration Process

If an employee believes the determined course of action is inappropriate, the employee may appeal or ask for the decision to be reconsidered by the CRC. Upon completion of the review, the collegiate approver will act on the recommendation.

VII. Enforcement

Failure to File. If a covered individual fails to file a required REPA, the Vice President for Research or designee will take administrative action. This may involve placing a hold on the covered individual's ability to conduct research or receive salary from the relevant sponsored project until the REPA form is filed and any potential conflicts are resolved.

The University maintains online reports of which individuals in a particular area have filed REPA reports. University compliance officers and the Office of Internal Audits use these reports to monitor compliance with the annual REPA reporting requirement.

Failure to Comply and Disciplinary Actions. Breaches of this policy include, but are not limited to, intentionally filing an incomplete, erroneous, or misleading disclosure form, failing to provide additional information as required by the approving authority, or failing to follow an approved plan for managing, reducing or eliminating a potential conflict. A violation of this policy may be the basis for discipline of an employee. If sanctions are necessary, they will be imposed in accordance with other applicable Board of Regents and administrative policies and procedures. The potential sanctions may include, but are not limited to, the following:

• letter of admonition;
• ineligibility of the employee for grant applications, Research Subjects Protection Programs (RSPP) approval, or supervision of graduate students;
• suspension;
• nonrenewal of appointment; or
• dismissal.

Reporting. If the covered individual fails to comply with this policy, then the dean of the unit must promptly inform the Vice President for Research of the violation and whether it has biased the design, performance, or reporting of research or other scholarly activity. The dean and Vice President for Research will follow the requirements of University Procedure 2.4.4.2, Reporting and Addressing Concerns of Misconduct in determining whether to report the violation centrally to the Office of Internal Audits, Office of Human Resources or the Office of the General Counsel. To the extent required by the sponsor, the Vice President for Research will notify the sponsor of the violation and any corrective action taken or to be taken.

VIII. Conflicts in the Review/Oversight Process

To avoid real or perceived conflicts of interest by participants in the conflict review and oversight process, the following recusal procedures will apply:

1. At meetings of the CRC, individual members will disclose any relationships or conflicts they may have related to the case under review. The CRC will vote as to whether to recuse the committee member from participating in the matter.
2. The Regulatory Affairs Officer (RAO) will recuse him/herself from review and oversight of all potential conflicts of interest involving employees in the RAO’s home department.