Subject: Personnel

Policy: Conflict of Interest Policy

Revised: August 24th, 2012; November 16th, 2012

Effective Date: August 24th, 2012

Review Date: August 2015

Responsible Party: Office of Research Compliance

Printable Version (.docx)

 

Scope

This policy applies to the following MSU Campuses:

  • MSU Bozeman (including MSU Extension, Agricultural Experiment Stations, and Gallatin College)
  • MSU Billings (including City College)
  • MSU Northern
  • Great Falls College MSU.

For the purpose of this policy, the term "University" means all campuses listed.

The Responsible Offical for each campus is:

  • MSU Bozeman - Director of the Office of Research Compliance (or designee)
  • MSU Billings - Director Human Resources (or designee)
  • MSU Northern - Director of Human Resources (or designee)
  • Great Falls College MSU - Director of Human Resources (or designee)

100.00 Introduction

The administration, faculty, and staff of the campuses of Montana State University (MSU or University) all bear the responsibility of serving the respective teaching, research, and service missions of the campuses. That mission is enhanced by the sustained, active interaction of members of the University community with business, government, not-for-profit groups, professional societies, academic institutions, and other individuals and organizations. Therefore, entrepreneurial activites are encouraged that support the University's mission through dissemination of knowledge, enhancement of educational opportunites for students, and economic development.

These many interactions and activities can, however, create the potential for conflict of interest in which University employees' external activities or interests could influence - or could appear to influence - the manner or extent to which those individuals carry out their University responsibilites. Such influences - real or apparent - may undermine public and professional confidence in the campuses, diminish the University's ability to accomplish its mission, and violate state or federal law. Typically, conflicts of interest can be dealt with effectively through disclosure and other steps to resolve or manage the conflict. Thus, an integral part of this Policy is the disclosure and management system detailed in section 500-600 below.

200.00 Policy

The campuses of Montana State University are committed to fulfilling its mission with integrity and in full compliance with state and federal ethics and conflicts of interest laws and regulations and with Montana Board of Regents Policy. A conflict of interest exists when an employee has a financial or personal interest in the outcome of an endeavor such that the employee's actions or decisions could be percieved as subject to influence in favor of the employee's interest, as more fully defined in section 410.

Therefore, it is the policy of the campuses of Montana State University that in all of their activites - the education of students; the design, conduct, and reporting of research; the hiring and supervision of staff; the procurement of materials and services; and all other tasks incident to their mission - each campus and its employees shall endeavor to be free of inappropriate influence or bias that may result from conflicts of interests. This Policy is intended to enable employees to recognize potential conflicting interests and, thus, to protect themselves and the University from inappropriate influence or bias through disclosure, evaluation, and, if required, management or elimination of conflict of interest.

210.00 Applicable Law, Regulation, and Policy

In addition to this Policy, employees' ethical conduct is governed by:

  • Montana law, Standards of Conduct - Title 2, Chapter 2, Parts 1-3, M.C.A
  • Federal regulations governing sponsored research. For example, the National Institutes of Health, governed by the U.S. Department of Health and Human Services (HHS) requires institutions recieving funding to have a conflict of interest policy which complies with its regulations [[insert links]]:
    • Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
    • Responsible Prospective Contractors (45 C.F.R. Part 94)
    • The Board of Regents Policy Section 770, Conflicts of Interest. This Policy is intended to implement the requirements contained therein.
    • The Board of Regents Policy Section 407, Approval of University System Employee Equity Interest and/or Business Participatio. This policy implements Section 20-25-109, MCA insert link.
    • Montana State University's Nepotism Policy

300.00 Applicability

This policy applies to all employees of campuses of Montana State University. Employees are expected to review and understand their obligations under this Policy and to be familiar with their obligations under the laws, regulations and policies referenced in Section 210 of this Policy.

400.00 Definitions

410.00 Conflict of Interest

A Conflict of Interest occurs:

  • When a University employee has a personal interest that could or could appear to compromise or impinge on the employee's obligation to the University to exercise the employee's best judgment in pursuit of the interest of the University and its students;
  • When a non-University activity could or could appear to unreasonably encroach on the time an employee should devote to the affairs of the University;
  • When an employee's non-University activites could or could appear to unreasonably impinge on or compromise the loyalty or commitment to the employee's University duties and responsibilites.
  • In sponsored research, when an Investigator's Significant Financial Interest could or could appear to directly and significantly affect, the design, conduct, or reporting of the research.

In determining whether a Conflict of Interest exists, an important consideration is whether an independent observer might reasonbly question whether the employee's professional actions or decisions are influenced by considerations of personal gain, financial or otherwise.

420.00 Significant Financial Interest

A significant Financial Interest (SFI) consists of one or more of the following interests of the employee (and those of the employee's Immediate Family):

  • An equity interest (including stock, stock options, or other ownership interest) of $5,000 or greater in any publicly traded entity as determined through reference to public prices.
  • Any equity interest (including stock, stock options, or other ownership interest) in any non-publicly traded entity.
  • Remuneration for services including annual salary, royalties, consulting fees, honoraria, paid authorship, or anything of monetary value (regardless of whether its value is readily ascertainable) that amount to $5,000 or more over the 12 months preceding the disclosure.
  • Intellectual property rights and interest (e.g. patents, copyrights), upon receipt of income related to such interests.

Significant Financial Interest does not include:

  • Salary, royalties, or other remuneration received from or through the University.
  • Intellectual property rights assigned to the University and agreements to share in royalties related to such rights.
  • Income from seminars, lectures, or teaching engagements sponsored by governments, institutions of higher education, academic teaching hospitals, medical centers or research institutes affiliated with institutions of higher education.
  • Income form service on advisory committees or review panels for governments, institutions of higher education, academic teaching hospitals, medical centers or research institutes affiliated with institutions of higher education.
  • Investments in and income from investment vehicles, such as mutual funds and retirement accounts as long as the employee does not directly control the investment decisions made in these vehicles.

430.00 Investigator

Principal Investigators, Project Director and all other employees who are responsible for the design, conduct, or reporting of sponsored research.

440.00 Immediate Family

The employee's spouse and dependents.

450.00 Sponsored Research

Research, creative activites, scholarship, training and instructional projects involving funds, materials, or other compensation from outside sources under agreement. Research in this context means a systematic investigation designed to develop or contribute to generalizable knowledge, including behavioral and social-science research.

460.00 Responsible Official

Each campus will designate Responsible Offical(s) or office to oversee the reporting, disclosure and management of potential conflicts of interest.

470.00 Investigator's Institutional Responsibilites

An Investigator's professional responsibilites on behalf of the University, including, but not limited to: research, teaching, service, professional practice, and institutional review board or other institutional committee membership.

500.00 Disclosure

The key mechanism for implementation of this Policy is disclosure. Disclosure allows the campus and the employee to evaluate personal interests to determine if they present Conflicts of Interest and to take appropriate action based on the evaluation. All employees (unless exempted as provided in section 530 below) must annually complete and submit a Conflict of Interest Disclosure Report, (See section 530 below). All employees, including those exempted from the annual disclosure requirements (See 530 below), are required to comply with this Conflict of Interest Policy and to make disclosures of any potential Conflicts of Interest (see section 510 and 520 below) whenever they occur to the designated Responsible Official.

510.00 Sponsored Research Disclosure

In Sponsored Research, all Investigators (including Graduate Research Assistants) must disclose Significant Financial Interests, including those of their immediate family, that would reasonably appear to be related to the Investigator's Institutional Responsibilites.

In addition to the above disclosure, all Investigators proposing or performing research funded by the PHS, must also disclose the following:

  • The occurance of any reimbursed or sponsored travel (i.e. that which is paid on behalf of the Investigator and immediate family) with an estimated value of $5,000 or greater (aggregated for each paying entity), related to his/her Institutional Responsibilites, provided however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by governmental entities, U.S. institutions of higher education, academic teaching hospitals, medical center, or research institutes affiliated with an institution of higher education. The disclosure must include:
    • the purpose of the travel
    • the identity of the sponsor
    • the destination
    • the duration of the travel
    • any additional information requested by MSU in accordance with the Public Health Service Financial Conflict of Interest ("PHS FCOI") regulations.

511.00

Disclosure shall be made before submitting a proposal for funding. On the MSU-Bozeman campus, employees will use the Research Disclosure Form and the Reimbursed or Sponsored Travel Disclosure Form included with the e-Proposal Clearance Form (ePCF) to the Office of Sponsored Programs (OSP), covering the previous 12 month period for income and travel. If the Significant Financial Interest has previously been disclosed on a Conflict of Interest Disclosure form and is up to date, a copy of the most recent disclosure may be attached to the ePCF in lieu of a new Research Disclosure Statement. The Research Disclosure Statement must be updated on the Annual Form as provided in section 530 below.

512.00

In addition, for as long as the Sponsored Research continues, new Investigators and existing Investigators acquiring new interests shall disclose Significant Financial Interests or reimbursed or sponsored travel (as defined in Section 510 above) that would reasonably appear to be related to the Investigator's Institutional Responsibilites. On the MSU-Bozeman campus employees will file a Research Disclosure Form and/or the Reimbursed or Sponsored Travel Disclosure Form with OSP. 

A new Investigator must make such disclosure before engaging in the sponsored research and an existing Investigator acquiring a new interest or receiving reimbursed or sponsored travel must disclose the interest or travel within 30 days.

514.00

The Responsible Official, in consultation with the Investigator, and the employee's supervisor, shall review all Invetigator disclosures to determine whether or not they constitute a financial conflict of interest as defined by the applicable federal regulations. This review shall determine (1) whether the Investigator's interest could be affected by the research or the research could affect the entity in which the Investigator has an interest, and, if so, (2) whether the interest could directly and significantly affect the research. If a financial conflict of interest exists, appropriate action to manage the conflict will be take as provided in this policy.

515.00

The University will provide initial and ongoing reports of Investigator financial conflicts of interest to PHS in accordance with the PHS FCOI regulations:

  • Prior to the expenditure of PHS funds
  • Within 60 days of identifying a new financial conflict of interest of an Investigator on any PHS-funded research
  • Annually

516.00

The University will make information concerning identified Financial Conflicts 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.

517.00

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.

520 Disclosure

All employees must disclose the following whenever they occur:

  • 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.
  • 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 the employee's University responsibilities.
  • 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 responsibilites.
  • The planned direct participation in a University decision which would or could appear to involve a direct benefit or detriment to:
    • A relative as defined in MSU's Nepotism Policy [/policy/personnel/per400.html#430.00]
    • A person in whom or with whom the employee has a financial interest
    • A person with whom the employee has a consensual romantic relationship.

525.00

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 Procurement Services for purchases and to the Property Managment Department for sales.

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 reveive 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.

526.00

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 MSU as provided in Board of Regents Policy Section 407 [http://mus.edu/borpol/bor400/407.pdf].

527.00

The acquisition of any personal or financial interest which creates a Conflict of Interest.

528.00

The disclosures required by this Section shall be disclosed to the Responsible Official for evaluation and possible managment.

530.00 Annual Disclosure

Annually, all employees (unless exempted as provided in Section 533 below) must complete and submit a Conflict of Interest and Consulting Report as follows:

  • Disclosure Forms shall be completed online via MyInfo upon receiving notification via email.
  • The employee's electronic completion of the Disclosure Form certifies that 1) the employee does not have an interest which require disclosure, 2) the employee has a potential conflict of interest which has been duly disclosed previously and there has been no change which requires an updated disclosure, or 3) the employee has new interests which create a potential conflict of interest and has disclosed them.

533.00

The following groups of employees are exempt from the annual disclosure obligation, (although they remain obligated to make disclosures under Section 510 and Section 520 above):

  • Employees working less than one-half time,
  • Classified employees.

540.00 Disclosure Submission

All Disclosures shall be submitted to the Responsible Official or designee. Upon request, records will be made available to the employee's supervisor, the appropriate dean (when applicable) or director, and any other supervisor in the line of authority.

600.00 Disclosure Review and Disposition

610.00 Initial Review

The Responsible Official shall review each form containing a disclosure and determine whether a conflict of interest exists.

620.00 Waiver of Conflict

The Responsible Official, in consultation with Legal Counsel if necessary, may waive the conflict and/or the need for a conflict management plan if they make the following written determinations:

  • That the conflict of interest is so remote that there is no significant probability for inappropriate influence or bias on the employee's University duties and responsibilites,
  • Any resolution of the conflict other than by disclosure and waiver would be ineffective or inequitable and the conflict is not prohibited by statue or regulations,
  • Any bias reasonably expected is outweighed by the interests of scientific progress, technology transfer or the public health and welfare, and the conflict is not prohibited by statute or regulation,
  • The relevant funding agency rules allow this type of conflict, and it is not incompatible with applicable law.

640.00 Conflict Management Plan

If a conflict of interest exists and does not meet the waiver criteria of section 620, the Responsible Official, the employee, Plan Manager and any others deemed helpful in assessing the situation, will develop a written Conflicts Management Plan to manage, reduce, or eliminate the inappropriate influence or bias, or the appearance thereof. The purpose of the plan is to:

  1. Accurately describe the potential conflicts in writing
  2. Create explicit agreements to protect against inappropriate influence or bias
  3. Facilitate oversight

641.00

The conflict management plan may employ safeguard strategies including, but not limited to, the following:

  • Public disclosure of the Significant Financial Interest,
  • Monitoring of the relevant employment duties (e.g. research) by independent reviewers,
  • Modification of duties of the employee, including modification of a research plan,
  • Disqualification from participation in the conflicting employment activity, such as research, procurement, student advising, or employee supervision,
  • Divestiture of the conflicting interest,
  • Severance of relationship that creates the Conflict of Interest.

642.00

Whenever a decision is made to manage rather than eliminate the potential for inappropriate influence or bias in a conflict that has not been waived, the Responsible Official shall make a written statement explaining why management is in the best interest of the University. Such statement may be included in the conflicts management plan.

643.00

Relevant questions to consider in designing an appropriate CMP Conflicts Management Plan include, but are not limited to:

  • What is the magnitude of the financial interest?
  • What is the level of incentive created by the interest?
  • How direct is the link between the interest and the duties of the employee, including research duties?
  • Could the conflict compromise the objectivity of research results or their evaluation and presentation?
  • Could the conflict adversely affect students?
  • Could the conflict unreasonably interfere with the employee's commitment to University responsibilities?
  • What are the relevant Funding Agency rules?
  • Can a reasonably knowledgeable person be identified to satisfactorily monitor the conflict?
    • Any individual identified to monitor a conflict must have the technical knowledge necessary to determine whether there has been inappropriate influence or bias in the results of a project, and must be free from influence of the parties to the conflicts management plan. The plan monitor must not report to the person being monitored.

644.00

A Plan Manager, typically a supervisor or department head, is assigned to monitor the plan and ensure that safeguards are followed. Plan Managers review plans with employees annually in the spring to cover the upcoming fiscal year. Plans are updated as circumstances change, and the annual reviews continue until the conflict no longer exists. Additional monitoring may take place at any other time of year.

700.00 Appeal Procedure

710.00 Appeal to President

If an employee believes the conditions or restrictions in the conflict management plan are inappropriate, the employee may appeal the decision 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 may, in his/her discretion, appoint and convene a Conflict Review Committee to provide advice on an appeal. The President's decision on the appeal shall be the final decision of the University.

720.00 Conflict Review Committee

If the President wishes to have the benefit of advice from a Conflict Review Committee, the President shall appoint a three member committee. The members shall include employees or community members who have had no involvement in the decision being appealed and who have relevant experiences or training to assess the conflict.

730.00 Montana University System Appeal

An employee who disagrees with the final decision of the University may appeal further as provided in the Board of Regents Appeal Policy, Section 203.5.2

800.00 Compliance Reporting and Record Retention

810.00 Sponsored Research

The Responsible Official and the campus office responsible for federal grant management are responsible for the following compliance duties related to conflict of interest in Sponsored Research, if required by the sponsoring agency:

  • Compliance of subgrantees, subcontractors and collaborators,
  • Submission of compliance certifications,
  • Reporting concerning conflicts of interest in research,
  • Notifying the sponsoring agency of financial conflicts of interest as required by the sponsoring agency,
  • Notifying the sponsoring agency if non-compliance with this policy has biased the design, conduct, or reporting of the funded research and identify the corrective action taken or to be taken to address the non-compliance,
  • Records of conflicts disclosure submitted with grant proposals and records of actions related to such disclosures shall be maintained in the grant or contract file for three years from the date of submission of the final expenditure report.

830.00 Records Maintenance

The Responsible Official shall maintain all disclosures and conflict management records (including copies of records kept for sponsored research disclosures) for the period of time required by state and federal laws and regulations. Records will be maintained in a manner to protect sensitive and confidential information consistent with state and federal law.

900.00 Compliance

 910.00

Each campus 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, erroneuous, or misleading disclosure form; failure to provide additional information as required; failure to provide a disclosure form as required by this Policy; failure to comply with University requirements concerning the conflict of interest; or failure to abide by a conflicts management plan.

920.00

A violation of this policy may be the basis for discipline of an employee. Such discipline will be imposed consistent with the discipline policies and procedures applicable to the particular employee.

930.00

Potential sanctions may include, but are not limited to, the following:

  • Letter of warning
  • Suspension or termination of participation in a Sponsored Research grant
  • Removal or suspension of privileges related to the violation, such as suspension of the privilege:
    • to apply for Sponsored Research grants or contracts,
    • to supervise graduate students,
    • to perform research which requires approval of a campus Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC) or Institutional Animal Care and Use Committee (IACUC).
  • Suspension without pay
  • Termination

940.00

If a campus discovers an Investigator conducting PHS-funded research has failed make any disclosure required in section 910 or to comply with a management plan, or if the campus has failed to review or manage a financial conflict of interest as required by the PHS FCOI regulations, the campus shall within 120 days, in accordance with the requirements of the PHS FCOI regulations, complete a retrospective review of the non-compliance and determine whether the research was biased by the non-compliance. Further, MSU will document and report its review in accordance with the PHS FCOI regulations.