POLICY ON RESEARCH CONFLICT S OF INTEREST

Policy Implemented: 31 May 2007

I. PURPOSE AND SCOPE

This policy sets forth the obligations of Oregon State University (“University”) and its employees with respect to conflicts of interest that involve the research mission.

As the University promotes and encourages new and varied collaborations, it is a natural by-product that relationships can appear to become tangled and questionable, regardless of whether this is the case. The design, conduct and reporting of research/scholarly activity should not be biased nor should the interests of students be compromised by any conflicting financial interest or other potential or actual personal gain of an employee. Adherence to the highest levels of professional integrity by faculty, staff and students in all their actions is required to avoid conflicts of interest.

This policy establishes two methods of reporting research conflicts of interest to the University. The first is through the annual reporting process. The second is through reporting on an as needed basis.

What Is a Research Conflict of Interest?

A research conflict of interest may occur when an employee is in a position to make a decision in the conduct of his or her research that may result in personal or family gain, financial or otherwise (see section II for definitions of Family and Significant Financial Interest). These conflicts often arise as a result of the employee’s external activities that are related to their research, teaching or outreach activities.

This policy recognizes that the potential for conflicts exist. The intent is to identify such relationships and to appropriately manage the relationships, if possible, in order to maintain the integrity of actions of all individuals. The primary goal is to maintain objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a Significant Financial Interest of an employee. Intellectual property, as a result of the research process, must be appropriately managed to avoid the appearance of inappropriate financial gain by involved individuals. D isclosing a potential conflict of interest in no way suggests an inappropriate action by an employee but is instead a necessary management process within the University.

What Is the Scope of the Policy?

Within the research mission, this Policy promotes objectivity in research by establishing expectations and disclosure requirements to ensure that the design, conduct and reporting of research will not be biased by a Significant Financial Interest of an employee. This Policy also includes the requirements of two federal agencies, the Public Health Service and the National Science Foundation, because their requirements are specifically established by agency regulation and policy.

Other laws and University policies also apply to interactions between University employees and organizations external to the University. They include the Oregon Government Standards and Practices Act, which addresses receipt of gifts by state employees and financial benefits to state employees that result from the employee’s official position; OSU’s Policy on Outside Professional Activities, which addresses conflicts of commitment to the University that may arise from outside activities; and the OSU Procurement, Contracting and Construction Contracting (PCC) Policy and Procedure Manual, which addresses conflicts that may arise in the University’s purchasing decisions. Other relevant policies also include, for Extension Faculty, Extension Guidelines on Outside Professional Activities, and Extension Service Policy: Service as an Expert Witness. To the extent that this Policy on conflict of interest conflicts with the OSU Policy on Outside Professional Activities, this policy controls. To the extent that this Policy on conflict of interest conflicts with the Extension Service policies, the Extension Service policies control.

What Does the Policy Call For?

Annual reporting by employees with tenure, tenure-track or senior research faculty rank, and others employee s as defined by the Conflict of Interest Officer, college dean or unit head (see Section VI for more information) .

Disclosure by all employees of outside activities create potential or actual conflicts of interest (see Section VI for more information) .

Disclosure by employees to the Office of Research Integrity of outside activities exceeding the significant financial interest threshold before submission of an application to funding agencies (see Sections III and X for more information).

Review of disclosures by appropriate individuals (see Section VII for more information).

Management or elimination of identified potential conflicts of interest (see Section VIII for more information).

 

II. DEFINITIONS

• “Conflict of Interest Officer” means the person appointed by the Vice President for Research to review all financial disclosures and identify and resolve conflicts.
  
• “Significant Financial Interest” means: a) an equity interest when aggregated for employee and family members that exceeds $10,000 in value or is more than a 5% ownership interest in a single entity, or b) salary (other than University salary), royalties or other payments when aggregated for the employee and family members that exceeds $10,000 for the next 12 month period.

• “Family” or “Family Member” means an employee’s spouse and the parents, children, brothers and sisters of either the employee or the employee’s spouse.

 

III. CONFLICT OF INTEREST WITHIN THE RESEARCH MISSION

All research , including all forms of scholarship and creative activities, at the University must be appropriate to the mission of the University (i.e. it must promise significant contributions to scholarship and knowledge and, when possible, provide educational opportunities for students). The independence of research must be maintained. Employees undertaking research should approach it free of bias and influence. When the potential for bias or influence exists due to a Significant Financial Interest of an employee, actions by employees must be managed in a manner that safeguards the integrity of the research process. University interactions with the private sector, including those with entities in which individual employees have a Significant Financial Interest, must be structured in a way that preserves the integrity of the research process.

Interactions between employees and external organizations must be carefully assessed for their possible negative effects on students. Part-time involvement of graduate students in the external or research activities of employees may, under certain conditions, offer the potential for substantial benefits to the education of the student; however they also create the potential for inappropriate decisions or actions that are not in the students’ best interests. In considering such arrangements, employees should be guided by the need to avoid conflicts of interest and to avoid infringement of the student’s academic duties and rights. For example, if the outside work is related to the student’s thesis, special care must always be taken to avoid conflicts that might hinder the student’s progress, delay acceptance of his or her thesis, or lead to altered examination standards. This is not intended to preclude the involvement of graduate research assistants in commercial activities or work that will not be used for evaluation of a student or fulfillment of degree requirements under arrangements otherwise consistent with this and other University policies.

Requirements Specific to Sponsored Research

Before submission of an application for funding, principal investigators and other key personnel (those directly involved in the design, conduct, and reporting of results) must disclose to the University any Significant Financial Interests that would reasonably appear to be affected by the proposed research for which funding is sought. Before funds are spent, the University must review the disclosure, determine whether there is a conflict and, if so, manage, reduce or eliminate.

The Public Health Service of the United States Department of Health and Human Services (PHS) and the National Science Foundation (NSF) have very specific requirements for identification, disclosure and management of conflicts of interest arising in research funded by those agencies (see Section X). See 42 CFR. Part 50; 45 CFR. Part 64. These federal requirements are in addition to - not a substitute for - the other provisions of this OSU policy. The PHS and NSF requirements apply specifically to applications or proposals to, and research conducted with funding from these two federal agencies.

Examples of Potential Research Conflicts of Interest

• Research of an employee that is supported through sponsored research, gift funds, or any other source of funding from an entity in which they have a Significant Financial Interest.
• An employee consulting for an entity in which they have a Significant Financial Interest that supports their research through sponsored research, gift funds, or any other source of funding.
• An employee’s service on the board of directors or major advisory committee of an external entity in which the employee has a Significant Financial Interest, where the entity sponsors the employee’s research or scholarship or provides gift funds or other source of funding for the use of the employee or his or her department.
• Participation as a principal investigator or co-investigator in a research project that evaluates the product of an entity in which the employee has a Significant Financial Interest.
• Research activities involving students that have the potential to benefit a business entity in which an employee has a Significant Financial Interest.

 

VI. REPORTING AND MANAGEMENT PROCESS

Under this Policy, all employee s are required to inform the University of potential conflicts of interest via the Conflict of Interest Reporting Form (hereafter called “Report”). The purpose of the Report is to solicit information that allows the University to determine whether the employee has a potential conflict of interest as described in this Policy. Within the constraints imposed by state law, Reports will be made a part of the employee’s confidential personnel record.

Any employee , who has a potential conflict of interest as described in this Policy, shall submit a Report to the employee ’s unit head when the potential conflict first arises, is recognized, or significant changes occur in the circumstances of a previously reported transaction or activity. In addition, annual reporting is required by employee s with tenure, tenure-track or senior research faculty rank, and other employee s as defined by the Conflict of Interest Officer, college dean or unit head. A unit head, college dean, vice provost, vice president, or Conflict of Interest Officer also has the discretion to require an employee to submit a Report at any time.

 

VII. REVIEW PROCESS

• Unit heads shall review Reports for completeness and accuracy and forward them to the college dean (or vice provost or vice president if not in an academic department).

• The college dean shall review each Report and forward it to the Conflict of Interest Officer.

• The Conflict of Interest Officer shall review submitted Reports, evaluate the nature and extent of potential conflicts, and resolve the case as discussed in Section VIII.

• Any disclosures that involve potential conflicts of interests with graduate students may also involve review by the Dean of the Graduate School or designee.

 

VIII. DECISION MAKING

The Conflict of Interest Officer or designee shall review all Reports and other information the Conflict of Interest Officer considers relevant, to evaluate whether a potential conflict of interest may exist, and to take appropriate action, as outlined below. At the request of the Conflict of Interest Officer, the Conflict of Interest Committee (“Committee”) will advise the Conflict of Interest Officer on any issues of potential or actual conflicts of interest.

The Committee shall be comprised of a minimum of six faculty members and staff from the campus at large representing the diversity of academic and research/scholarship disciplines and administrative functions of the University. Faculty members are appointed to the Committee by the Vice President for Research. The Committee shall include as ex-officio, non-voting members the Director of the Office of Research Integrity and the Director of Technology Transfer. A quorum consists of greater than 50% of voting members. The Office of the General Counsel shall advise the Committee. The Committee shall serve in an advisory capacity to the Conflict of Interest Officer. The Conflict of Interest Officer shall evaluate and make decisions on actual or potential conflicts of interest, taking into account the Committee’s recommendations, if any, in formulating a resolution.

A Committee member shall not participate in the discussion or vote on a particular case if the Committee member has a personal interest in the case under consideration or the Committee member has a Significant Financial Interest in the case under discussion. A Committee member shall not participate in any voting on a particular case if it involves members of their academic unit (department or comparable functional unit) but may be involved in discussions of the case at the discretion of the Committee chair.

The Conflict of Interest Officer shall determine the appropriate resolution of a conflict of interest. Resolution of a conflict may include, but is not limited to: a) determination that no conflict of interest exists, in which case the employee shall be informed and the matter closed, b) determination that a conflict of interest may exist, in which case the Conflict of Interest Officer shall work with the employee and his or her immediate supervisor (and any other administrators who should be involved) on a plan to eliminate or manage the conflict (“Management Plan”). Situations involving complex relationships may take 6 to 12 months for resolution and implementation of appropriate management.

A Management Plan may include a range of actions, for example, modifications to the research plan; appointment of an oversight panel or person to review the research/scholarship; appointment of an oversight person or panel to monitor the use of students and staff; disclosure of significant conflicts at presentations of the results of the research; limitations on the employee’s involvement in personnel decisions on behalf of the University; transfer of purchasing authority; divestiture of financial interests, or severing relationships that constitute actual or potential conflicts. A Management Plan shall be in writing and shall be signed by the Conflict of Interest Officer, the college dean, the unit head, and the employee.

Failure to comply with this policy may subject an employee to sanctions up to and including dismissal, in accordance with OAR 580-21-0320 et seq. The severity of the sanction will depend on the nature of the violation of this policy. Inadvertent, unintentional and minor breaches require lesser sanctions, whereas knowing, deliberate and major violations demand the severest sanctions.

When sanctions involve a conflict of interest that includes an externally funded research or scholarship project, the University will also take any action legally required by the funding sponsor.

 

IX. APPEALS

An employee may appeal a decision of the Conflict of Interest Officer to the Vice Provost for Academic Affairs and International Programs. If the conflict involves externally funded research, the Vice Provost for Academic Affairs and International Programs shall consult with the Vice President for Research.

 

X. SPECIFIC INSTITUTIONAL REQUIREMENTS FOR PHS AND NSF

For the purpose of this Section X of this policy, “Investigator” means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the Public Health Service (PHS) of the National Science Foundation (NSF) or proposed for such funding.

The University shall, for any federal research funding from the PHS or the NSF, or any other federal funding agency that imposes these requirements:

• Include in any sub-grant, subcontract or other sub-award a requirement that the sub-grantee, subcontractor or sub-awardee comply with this policy.
• Maintain for at least three years from the date of submission of the final expenditures report all records of financial disclosures and all actions taken by the University.
• Report any conflicting interest to the awarding component that issued the award prior to expending any funds.
• Report any interest identified as conflicting subsequent to the initial report within 60 days of that identification.
• Make the conflict information available, on request, to the funding agency.
• Promptly notify the awarding component of the funding agency of the corrective action that has been taken, if an Investigator has biased the research.

 

In addition, the University shall:

• For a PHS-funded project to evaluate a drug, medical device or treatment conducted by an Investigator with a conflict that was not disclosed or managed, require Investigators to disclose the conflict in each public presentation of the results of the research.
• For an NSF funded-project, inform NSF’s Office of the General Counsel appropriately informed if it is unable to satisfactorily manage a conflict of interest.

 

XI. REFERENCES

• National Science Foundation Policy, Investigator Disclosure Policy, Grant Policy Manual 510, 60 F.R. 132, pp 35810-823, July 11, 1995.

• U. S. Department of Health and Human Services, Objectivity in Research, Subpart F – Responsibility of Applicants for Promoting Objectivity in Research for Which Funding is Sought, 42 CFR Part 50, Subpart F (for HIH Contracts, Responsible Prospective Contractors, 45 CFR Part 94, Sections 1, 2, 3, 4, 5 and 6)

• OSU Policy on Outside Professional Activities

• OSU Procurement, Contracting and Construction Contracting (PCC) Policy and Procedure Manual, PCC 102-02: Conflicts of Interest policy

• Oregon Revised Statutes, Chapter 244; ORS 351.067

• Oregon Administrative Rules 580-021-0025; State Board of Higher Education Internal Management Directive 4.011 and 4.015

 

XII. ADDITIONAL INFORMATION

Questions about this Conflict of Interest Policy should be directed to the Conflict of Interest Officer.