Disclosing Potential Individual Conflicts of Interest

1. INDIVIDUALS REQUIRED TO COMPLETE THE DISCLOSURE FORM

Covered individuals are required to complete the disclosure form annually, even if they have no external activities or interests to report. Covered individuals are:

A. Paid academic employees: all academic employees holding a paid appointment, at any percent time in the faculty (94xx) or academic professional or administrative (93xx, 96xx, 97xx) appointee groups.

B. Individuals with research responsibilities (responsible for the design, performance, or reporting of research), including:

• unpaid academic employees;
• adjunct, temporary, clinical, or visiting academic employees;
• any employee (academic or civil service) or student, paid or unpaid, who serves as principal investigator, co-investigator, or key personnel on a sponsored project;
• principal investigators or co-investigators on Research Subjects Protection Program (RSPP) protocols (projects using animal or human subjects).

See Appendix A for further clarification of reporting requirements for particular appointment situations.

II. INDIVIDUALS EXEMPT FROM COMPLETING THE DISCLOSURE FORM

Paid academic appointees in the following classifications who do not have research responsibilities are exempt:

• a primary appointment of appointment type Adjunct (A), Temporary (T), Clinical (U), or Visiting (V);
• a primary appointment with an employment status code other than A (Active), L (Leave of Absence), P (Leave with Pay), S (Suspended), W (Short Work Break), or X (Retired-Pension Administration);
• a primary appointment of appointment term Z (hourly, summer term, lump sum) or 0 (not applicable; temporary or casual); or
• a part-time appointment solely for the purpose of classroom instruction, with responsibility for no more than two courses annually

III. WHERE TO FIND THE DISCLOSURE FORM

The disclosure form, also know as the Report of External Professional Activities (REPA) form, is located at http://egms.umn.edu/REPA. This website also provides secure access to previous disclosures.

IV. WHEN DISCLOSURE IS REQUIRED

1. Disclosure is required annually (at the start of the academic year).

   Each fall, covered individuals must submit annual REPA forms even if they have no external activities or interests to report. This annual REPA is in addition to any REPA that they file during the year. The reporting period runs from approximately September 1 to August 31 of each year (specific dates are determined each year by the Office of Regulatory Affairs).

2. Disclosure also is required under these circumstances:
   1. When substantial changes in financial or business interests take place.

      An updated REPA disclosure must be completed within 30 days of the time that the change occurs. "Substantial change" includes, but is not limited to, an increase in the value of an existing financial interest to a value that qualifies it as a significant financial interest.

   2. Before initiating an activity or external relationship that has a potential for a conflict of interest

      Any time a covered individual plans to initiate an activity that may be classified as having a potential for conflict of interest, the individual must complete a REPA form and all potential conflicts of interest must have an approved plan that manages, reduces or eliminates the conflict before initiating the activity .

   3. When submitting a proposal for sponsored project.

      All principal investigators, co-investigators, and key personnel must have a current REPA on file at the time of proposal submission (for internal and external sources of support). If the last REPA form was filed over 12 months from date of submission, or if the most recently filed REPA does not reflect current information, the covered individual must update the previous disclosure.

      Also, covered individuals must complete a REPA when they have a potential conflict of interest with the sponsor of the research.

      The principal investigator will not be able to spend award funds until the REPA is reviewed and approved, and a management plan is implemented (if necessary).

   4. When submitting a new or continuation application form to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), or Institutional Biosafety Committee (IBC).

      All principal investigators and co-investigators must have a current REPA on file at the time of application submission. If the last REPA form was filed over 12 months from date of submission, or if the most recently filed REPA does not reflect current information, the covered individual must update the previous disclosure.

      Note: read these applications carefully. Disclosure requirements may be more stringent for research involving humans, animals or potentially hazardous materials.

      The IRB, IACUC, and IBC committees will not give final approval until all potential conflicts of interest have been resolved.

   5. When receiving a contribution that has the potential of creating or appearing to create a conflict of interest.

      Covered individuals must complete REPA forms within 30 days of receiving contributions from businesses in which they have a business or significant financial interest if:

      1. the contribution exceeds a value of $1,000 in a given year; and
      2. the individual knows or reasonably should know that any portion of the contribution will be used to benefit his or her teaching, research, outreach, or public service activities.

   6. When involved in review or advisory activities.

      Covered individuals must temporarily excuse themselves from any University committee or review process that is considering an activity in which they have a business or significant financial interest. An example is serving in an executive position for any organization that does business with the University or sets policies or rules that affect the University's activities.

      These individuals must disclose potential conflicts of interest in writing (a REPA is not necessary) to committee chairs or the appropriate administrator.

   7. When involved with technology transfer.

      The Office for Technology Commercialization checks for potential conflicts of interest when they evaluate invention disclosures.

      Covered individuals must complete REPA forms and all potential conflicts of interest must be resolved before any licensing agreement is signed.

   8. When communicating with external entities

      Covered individuals must disclose relevant business or significant financial interests to sponsors of research as required by the sponsor.

      When submitting a paper for publication, a covered individual must disclose to the editor any business or significant financial interest that may be affected by publication. This provision also applies to release of information to news media.

      Covered individuals must also disclose relevant business or significant financial interests when they make an appearance, either in person or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issue or matter up for consideration, discussion, or action.

V. DELEGATING THE TASK OF COMPLETING THE DISCLOSURE FORM

A covered individual may delegate to a University employee the task of completing the disclosure form. However, the covered individual must be set up in the system to approve the form. Call the EGMS helpline at (612) 624-1600 to establish this authority. If this task is delegated, the covered individual must review the data on the form and approve it before it is sent to the departmental and collegiate approvers.

VI. ACTIVITIES EXEMPT FROM DISCLOSURE

The following activities do not create a potential conflict of interest and are exempt from disclosure. They are allowable if they are consistent with other University policies.

1. Receiving income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
2. Receiving income by serving as a special reviewer or on a review panel for a public or nonprofit entity.
3. Receiving royalties under the University's royalty-sharing policy but not having any other relationship with the royalty-granting entity that could result in a conflict of interest.
4. Participating in a private practice plan pursuant to Regents policies.

VII. DISCLOSURE OF CONFLICT OF INTEREST SITUATIONS

The following list of conflict of interest situations is only representative. Any combination of activity and external relationship not specifically represented here that a covered individual reasonably believes constitutes a potential conflict of interest must be reported in the "comments" section of the REPA. The department approver will determine whether the relationship represents an activity requiring further review. In addition, the assigned level of risk is a general guideline, and the department approver has the authority to require additional review and oversight for any low-risk situation.

A. Activities with a Minimal to Moderate Potential for Conflict: These activities are normally allowable but the departmental or collegiate approver may request oversight or other management.

1. Research Activities.
   1. A covered individual participating in research on a technology, process, or product developed in whole or in part by that individual in which the individual, an immediate family member, or an associated entity is entitled to receive royalties from an existing agreement with a business under another academic institution's royalty-sharing policies, but has no other business or significant financial interests in the project.
   2. An covered individual assigning students, postdoctoral fellows, or other trainees to research projects in which the covered individual, an immediate family member, or an associated entity is entitled to receive royalties from an existing agreement with a business under the University's or another academic institution's royalty-sharing policies, but has no other business or significant financial interests in the project.

2. Instructional Activities. A covered individual assigning students or other trainees to instructional projects, for example, design projects, in which the covered individual, an immediate family member, or an associated entity has a business or significant financial interest.

B. Activities with Moderate to High Potential for Conflict: These activities require case-by-case review. They are reviewed by the departmental and collegiate approver but must be referred to the Conflict Review Committee for evaluation and management

1. Research Activities.
   1. A covered individual participating in clinical trials or evaluation or development of a technology, process, or product owned or controlled by a business in which the individual, an immediate family member, or an associated entity has a business or significant financial interest.
   2. A covered individual assigning students, postdoctoral fellows, or other trainees to projects supported by a business (through sponsored research or a contribution) in which the covered individual, an immediate family member, or an associated entity has a business or significant financial interest, other than royalty income or the entitlement to future royalty income under University royalty-sharing policies.
   3. A covered individual receiving University-supervised sponsored research support or contributions (whether in dollars or in kind) for research from a business in which the individual, an immediate family member, or an associated entity has a business or significant financial interest, other than royalty income or the entitlement to future royalty income under University royalty-sharing policies.

2. Business Interests.
   1. A covered individual receiving research support (sponsored research or a contribution) from a business in which the individual or an immediate family member serves on the board of directors or advisory board.
   2. A covered individual or immediate family member holding an executive position in a business engaged in commercial or research activities directly related to the individual's University responsibilities

3. Administrative Responsibilities.
   1. A covered individual taking administrative action on behalf of the University with respect to the University or any University-affiliated organization that is beneficial to a business in which the covered individual, an immediate family member, or an associated entity has a business or significant financial interest.
   2. A covered individual taking administrative action on behalf of the University with respect to any supported research activity (sponsored research or a contribution) in which the covered individual, an immediate family member, or an associated entity has a business or significant financial interest in the sponsor or donor.

4. Professional Referrals. With the exclusion of consulting activities that conform to the consulting policy, covered individuals while acting in the context of their University duties making professional referrals to a business in which they, immediate family members, or associated entities have a business or significant financial interest of which they are aware or reasonably should be aware. Only in special situations should full-time employees be permitted to engage in this type of activity, for example, when the function is not generally available from other sources and the covered individual fully discloses relevant business or significant financial interest to prospective clients.