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Research Development and Compliance

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IV. PROCEDURES

This policy uses disclosure as the key mechanism to bring conflicts of interest to light for further evaluation and, when necessary, for oversight. Personnel are required to take the initiative to report promptly all activities or situations that may involve a conflict of interest. If changes occur in an employee’s activities, situation, or financial status that are relevant to the initial report, the employee is required to inform the University of these changes. Finally, conflicts span a wide spectrum, from minor and inconsequential to those that have such a serious impact that they cannot be permitted; therefore, existence of a conflict, real or potential, will not necessarily exclude a particular activity.

A. Financial Disclosure

 

1.

On an annual basis, all personnel are required to disclose information relevant to conflicts of interest. Personnel, for the purposes of this policy only, are all persons who are employed by the University on a full-time, part-time, or contract basis. It also includes graduate students who hold research, service, or teaching appointments; or persons serving as volunteers who may have a potential conflict of interest.

 

2.

Principal Investigators must also assure that personnel listed in a proposal or potential contract have filed appropriate documentation as described in section IV.B.

   
B. Documentation (Forms 1-4 are attached)
 

1.

All University Personnel

    a. Annually, all personnel must file with the Executive Head of the unit, a Financial Interests Disclosure Document (Form 1) and a Conflict of Commitment Document (Form 2).
      i. If any employee declares a significant financial interest on Form 1, a Description of Financial Interest Activity (Form 3) must be completed for each entity or activity and submitted to the Executive Head of the unit.
      ii. The director of purchasing will be given a list of those authorized to enter into financial transactions on behalf of the University, or those who are in a position to influence those transactions.
    b. If the employee’s status changes during the year regarding financial/business interests and/or time commitment, Forms 1, 2, and 3 must be revised at the time of the change.
   
 

2.

Principal Investigators

    a. In addition to the documentation required for all personnel, Principal Investigators submitting an external grant proposal must have on file with the Office of the Vice President for Research a current Certification of Filing of Financial Interests Disclosure Document (Form 4). Form 4 remains valid for a one year period.
    b. Extramural proposals cannot be submitted until all conflict of interest issues have been resolved and documented. Therefore, it is incumbent on the investigator to have the appropriate documentation and approval(s) prior to submission of a proposal for University review.
    c. If the employee’s status changes during the year regarding financial/business interests and/or time commitment, such that it affects the design, conduct, or reporting of the research or educational activities of a proposal, Forms 1, 2, and 3 must be resubmitted to reflect the change.
   
C. Evaluation

 

1.

Executive Heads of units have the responsibility to evaluate, document, and manage all potential conflict situations.

 

2.

The office of the Vice President for Research is the office of record for all conflict of interest documentation.

 

3.

The employee has the responsibility to respond to inquiries from the University in connection with any report.

 

4.

The Executive Head must review all relevant forms and complete Section II of the Financial Interests Disclosure Document (Form 1) and/or Conflict of Commitment Document (Form 2). The review has two possible designated outcomes:

    a.

No conflict of interest exists:

The requested activity may then take place, provided it is in compliance with other University policies and procedures.

    b.

A conflict of interest may exist:

The requested activity may then take place, provided it is in compliance with other University policies and procedures.

   
  In all cases, completed and signed original documents must be forwarded to/retained by the office of the Vice President for Research.
     

 

5.

The Vice President for Research or his/her designee has the responsibility to evaluate and render a decision regarding all potential conflict of interest cases that have been forwarded to him/her. The Vice President for Research or his/her designee may consult outside experts before reaching a decision. The Vice President for Research or his/her designee must review all relevant forms and complete Section III of the Financial Interests Disclosure Document (Form 1) and/or Conflict of Commitment Document (Form 2). The evaluation has four possible designated outcomes:

    a.

No conflict of interest exists:

The requested activity may then take place, provided it is in compliance with other University policies and procedures.

    b.

A minor conflict of interest exists but it does not place the University at risk.

Therefore, the activity is permitted with no conditions imposed.

    c.

A conflict of interest exists and the activity is limited by conditions detailed in a Memorandum of Understanding between the Investigator and the Vice President for Research or his/her designee.

    d.

A significant conflict of interest exists that cannot be managed by imposition of conditions, and involvement in the activity is prohibited.

 

 

Upon completion, the signed original will be retained in the office of the Vice President for Research and copies will be sent to the Executive Head and employee. If a Memorandum of Understanding is required, the Vice President for Research or his/her designee shall draft the document and forward it to the Executive Head and employee for signatures. The signed original Memorandum of Understanding must be retained by the office of the Vice President for Research and a copy must be sent to the Executive Head and employee.

D. Conflicts Involving Administrators

 

1.

In actual or potential conflicts of interest involving administrators at the level of Dean, Director, or higher, initial disclosure will be made to the Vice President for Research or his/her designee, who will make a recommendation consistent with this policy. Appeals will be handled as stipulated in section IV.E of this policy.

 

2.

In actual or potential conflicts of interest involving Vice Presidents, disclosures will be reviewed by the President, who will have final approval authority. Appeals will be handled as stipulated in section IV.E of this policy.

 

Following review, the signed original must be retained in the office of the Vice President for Research and the Administrator will be notified of the decision in writing. If a Memorandum of Understanding is required, the Vice President for Research or his/her designee or President shall draft the document and forward it to the Administrator for his/her signature. The signed original Memorandum of Understanding must be retained in the office of the Vice President for Research and a copy sent to the Administrator.

 

   
E. Appeals

 

An appeal of the decision by the Vice President for Research or his/her designee or by the President in the case of conflicts of interest involving Vice Presidents may be initiated by the employee.

 

1.

The employee must submit a written appeal to the Vice President for Research or his/her designee within 30 working days of receiving written notification of the decision. The appeal will then be forwarded to the Conflict of Interest Committee, which will evaluate it and make a determination within 30 working days.

 

2.

In the case of a vice president, she/he must submit a written appeal to the President within 30 working days of receiving written notification of the decision. The appeal will then be forwarded to the Conflict of Interest Committee, which will evaluate it and make a determination within 30 working days.

 

3.

The Committee’s decision will be binding and will be conveyed in writing to the employee and the Executive Head. The original document will be retained by the office of the Vice President for Research.

   
F. Management of Conflict of Interest

 

1.

If a conflict of interest is deemed to exist and the activity is permitted, the Executive Head will monitor the situation to ensure compliance with the Memorandum of Understanding.

 

2.

Prior to expending any funds, and if required to do so by funding agency policy, the Vice President for Research or his/her designee will notify the funding agency and provide written assurance that the conflict of interest is being managed, reduced, or eliminated in accordance with agency requirements.

 

3.

The University of North Dakota will maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for ten years after: the termination of the award, completion of the award, or the resolution of any government action involving those records.

     
G. Other Situations Subject to Review and Approval

 

1.

For situations not involving a financial conflict of interest or a conflict of commitment (e.g., significant use of University facilities or resources, student involvement in research with a publication restriction, technology transfer, etc.), the employee will submit a request in writing, explaining all pertinent circumstances, to the Executive Head of the unit.

 

2.

The Executive Head of the unit will provide a decision and reasons for the decision in a timely fashion. The Executive Head will have the option of referring the matter for consultation or final decision-making to a higher level, such as a Vice President.

 

3.

The official file for all requests and determinations will be located in the office of the Vice President for Research.

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Research Development and Compliance
Twamley Hall Room 105
264 Centennial Drive Stop 7134
Grand Forks, ND 58202-7134
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