Conflict of Interest and Financial Disclosure

See UM's Conflict of Interest and Financial Disclosure Policy 

I. Disclosure Requirements

The key mechanism for implementation of this Policy is disclosure.  Disclosure allows the University and the employee to evaluate personal interests to determine if the interests present Conflicts of Interest and to take appropriate action based on the evaluation.  All full-time University faculty and other employees must annually complete and submit a Conflict of Interest Disclosure Form ("Disclosure Form") as noted below.  Faculty members or other  employees working less than half-time are  exempt from submitting the annual Disclosure Form, but nonetheless are required to comply with UM conflict of interest policies and to make disclosures of any potential Conflicts of Interest whenever they occur.

A. Disclosure by all UM Faculty and Employees. All employees must disclose the following when they occur:

1. The acquisition by the employee, or a member of his/her Immediate Family, of a  Significant Financial Interest in an entity engaged in commercial or research activities directly related to the employee’s University responsibilities.
2.  The holding of an executive or officer position in or serving as a member of the board of directors of an entity engaged in commercial or research activities directly related to the employee’s University responsibilities.
3. An immediate family member holding an executive or officer position in or serving on the board of directors of an entity engaged in commercial or research activities directly related to the employee’s University responsibilities.
4. The planned direct participation in a University decision which would involve a direct benefit or detriment to: A relative as defined by UM’s Nepotism Policy; A person in whom or with whom the employee has a financial interest; or A person with whom the employee has a consensual romantic relationship.
5. Any financial interest of the employee or an Immediate Family member in an entity involved in a University purchase or sale whenever the employee is in a position to recommend or approve the purchase or sale.  Such interests must be disclosed to the Procurement Department in Business Services.  NOTE: This disclosure requirement does not include textbook adoptions when the employee is clearly identified as an author, contributor, or editor of the textbook under consideration.  However, faculty members should not receive a profit as a result of recommending a specific vendor for the purchase of texts or course materials by their students, whether on-line or from other sources.
6. Participation as an employee, officer, board member, or owner in an entity which has (or wishes to have) rights to intellectual property for which you were an inventor or creator in your work for UM as provided in Board of Regents Policy § 407.
7. The acquisition of any personal or financial interest which creates a potential Conflict of Interest.
8. The disclosures required by this Section shall be submitted on the Conflict of Interest Disclosure Statement and Certification Form.

B. Disclosures by Principal Investigators of Sponsored Research

1. In Sponsored Research, all Investigators (including Graduate Research Assistants) must disclose Significant Financial Interests, including those of their Immediate Family:
         a. That would reasonably appear to be affected by the Sponsored Research; or
         b. In entities whose financial success would reasonably appear to be affected by the research.
2. Before submitting a proposal for funding, an investigator shall make any real or potential conflict of interest known to UM by submitting a Disclosure Form to the Office of Research and Sponsored Programs(ORSP) along with the Checklist via E-Prop.  If the Significant Financial Interest has previously been disclosed on a Disclosure Form and is up to date, a copy of the most recent disclosure may be attached.
3. In addition, for as long as the Sponsored Research continues, Investigators shall disclose any new acquisition of a Significant Financial Interest by filing an updated Disclosure Form with the Office of Legal Counsel, with a copy to ORSP, within 30 days of acquiring such Interest. 
4. Legal Counsel, in consultation with the Investigator, the Vice President for Research and the Investigator's supervisor, shall review all Investigator disclosures to determine whether or not the disclosures constitute a financial conflict of interest as defined by the PHS FCOI regulations.  If a financial conflict of interest exists, appropriate action to manage the conflict will be taken as provided by this policy.
5. The University will provide initial and ongoing reports of Investigator financial conflicts of interest to PHS in accordance with the PHS FCOI regulations:
   1. Prior to the expenditure of PHS funds; 
   2. Within 60 days of identifying a new financial conflict of interest of an Investigator on any PHS-funded research; and 
   3. Annually 
6. The University will make information available concerning identified Financial Conflict of Interest held by senior/key personnel on PHS-funded research (as defined in the  PHS FCOI regulations) to any requestor within five business days of a request in accordance with the requirements of the PHS FCOI regulations. 
7. All Investigators performing research on any PHS-funded projects shall complete financial conflict of interest training prior to engaging in such research and at least every four years thereafter and as otherwise required by PHS FCOI regulations.  Online training is available at CITI Collaborative Institutional Training Initiative. 

C. Annual Disclosure. Annually, all employees (.5 FTE and greater) must complete and submit a Disclosure Form as follows:

1. Disclosure Forms must be completed and filed by September 30 of each year AND any time a new potential conflict of interest arises.
2. The employee’s signature on the Disclosure Form certifies that the employee has read and understands this Policy; and that either 1) the employee does not have a conflict of interest and is in compliance, or 2) that the employee has appropriately disclosed any interests which create a conflict of interest.

D. Disclosure Submission. Disclosures shall be submitted to the employee's Academic Dean or Director for signature; the Academic Dean or Director shall forward the disclosure to the Office of Legal Counsel for review and evaluation.

E. Submission to President.  All disclosure forms of executive employees reporting directly to the President shall be submitted to the President of the University and the Office of Legal Counsel.

F. Optional Conflict Management Plan Submission.  Any of the above disclosures may be accompanied, at the employee's option, by a proposed conflict management plan; a plan template is available from the Office of Legal Counsel (243-4742), and that office is available to answer questions or provide help with a plan.

II. Disclosure Review and Disposition

A. Initial Review

The Office of Legal Counsel shall review each Disclosure Form containing a disclosure and determine, in consultation with the Responsible Vice President or the President, whether a conflict of interest exists.

B. Waiver of Conflict

The Office of Legal Counsel, in consultation with the Responsible Vice President or the President for disclosures made under Section I.E. above, may waive the conflict and the need for a conflict management plan if they make the following written determinations:

1. The conflict of interest is so remote that there is no probabiloty for bias in the overall conduct of the sponsored activity, or
2. Any resolution of the conflicts other than by disclosure and waiver would be ineffective or inequitable, or
3. Any bias reasonably expected is outweighed by the interests of scientific progress, technology transfer, or the public health or welfare.

C. Conflict Management

If a Conflict of Interest exists and is not waivable, the Office of Legal Counsel, in consultation with the Responsible Vice President, or the President, the employee, and any others deemed helpful in assessing the situation, shall determine if any restrictions should be imposed on the faculty member or other employee in order to manage, reduce, or eliminate the conflict of interest.  These conditions and restrictions should be described in a Conflict Management Plan.

D. Examples of Conditions or Restrictions

Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest include but are not limited to:

1. public disclosure of significant financial interests;
2. monitoring of research by independent reviewers;
3. modification of the research, educational, or public service activities plan;
4. disqualification from participation in all or a portion of the research;
5. divestiture of significant financial interests; or,
6. severance of relationships that create potential conflicts of interest.

E. Questions

Relevant questions to consider in designing an appropriate conflict management plan include, but are not limited to:

1. What is the magnitude of the financial interest?
2. What is the level of incentive created by the interest?
3. How direct is the link between the interest and the duties of the employee, including research duties?
4. Could the conflict compromise the objectivity of research results or their evaluation and presentation?
5. Could the conflict adversely affect students?
6. Could the conflict unreasonably interfere with the employee’s commitment to University responsibilities?
7. Can a reasonably knowledgeable person be identified to satisfactorily monitor the conflict?

III. Appeal / Reconsideration Procedure

A. Appeal to President

If an employee believes the conditions or restrictions in the conflict management plan are inappropriate, the employee may appeal to the President, unless the President was involved in the decision appealed, in which case the President’s decision is the final decision of the University.  The President will then refer the appeal to a Conflict of Interest Review Committee (CIRC) (see Section VI below for membership and guidelines) to have the activity reconsidered.

 Upon completion of the review, the President will consider the CIRC recommendation(s), if any, and render a decision.

B. Montana University System Appeal 

An employee who disagrees with the President’s decision may appeal to the Montana Commissioner of Higher Education under Board of Regents Policy 203.5.2 and exercise any applicable rights permitted by Article 19 of the UM University Faculty Association Collective Bargaining Agreement or the Regents appeal policy and procedure.   No grant award will be accepted by UM while any appeal is pending.

IV. Reporting and Record Retention

A. The Vice President for Research will report to external sponsoring agencies as required by the agencies 1) the existence of any conflict of interest found by UM; and 2) actions taken to manage, reduce, or eliminate the conflict.

B. The Vice President for Research will maintain records of all Checklists via E-Prop, Disclosure Forms, and all actions taken by UM, on an award-by-award basis, for at least three (3) years beyond the termination of the award or until resolution of any action by UM or governmental agencies involving the records. All records will be maintained in a manner to protect sensitive and confidential information consistent with state and federal law.

C. To the extent required by law or requested by the sponsor, the President or Vice President for Research will also inform the Office of UM Legal Counsel of any external sponsor of UM research activity whenever UM finds itself unable to manage and satisfactorily resolve any conflict of interest related to the sponsor’s UM activities.

V. Compliance

A. UM expects all employees to comply fully and promptly with all requirements of this policy.  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, or failure to provide a Disclosure Form to the Vice President for Research as required.

B. A violation of this policy may be the basis for discipline of a faculty member or other employee. If sanctions are necessary, they will be imposed in accordance with applicable MUS policies and the UM University Faculty Association Collective Bargaining provisions.

C. The potential sanctions may include, but are not limited to, the following:

1. Letter of admonition;
2. Ineligibility of employee to submit grant applications;
3. Withholding Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval, or supervision of graduate students;
4. Suspension;
5. Non-renewal of probationary appointment;
6. Termination

VI. Conflict of Interest Review Committee (CIRC)

A. Formation and Membership

1. The President will determine whether a CIRC should be organized to assist in reviewing (or upon appeal by the employee) the potential for conflicts of interest regarding research and gifts.
2. In consultation with Faculty Senate and appropriate Deans and other administrators, the President will be responsible for appointing committee members to one or more CIRCs.
3. A CIRC may be organized by school (multiple departments) or for a particular department if the number of such cases or their nature justifies a separate committee.
4. Three-quarters of the voting membership of each CIRC will be faculty members or other employees from the area or department(s) to be served. The remaining one-quarter of the voting members will include faculty from outside the department(s).
5. At least one of the members should be an individual who has participated or is currently participating in approved external relationships.
6. Each CIRC will also include non-voting representation by the Director of the Office of Technology Transfer.

B. Guidelines

1. The principal objective for the CIRC is to help guard UM employees and UM from engaging in activities where the risk to integrity and reputation as a result of an external relationship outweighs the value of the activity to academic and societal goals.
2. Relevant factors to consider are the nature of the financial interest, where and when the relationship commenced, whether the conditions of the relationship have changed during the past year, the likelihood of a conflict of interest (will the results of the activity likely effect or be effected by the significant financial or other interests), mechanisms to ensure integrity (peer review, other independent research sites, and independent monitors and controls), the importance of the proposed activity, and the availability of alternatives to avoid the conflict of interest.

Reference:  

Effective date: August 24, 2012:  HHS Final Rule on Objectivity in Research (Federal Register Vol.  76, No. 165, August 25, 2011;  Revised Rule Changes 

Effective date:  October 1, 1995:  On July 11, 1995 , the final notice for implementation was published in the Federal Register with NSF and HHS working in tandem