Policy on Research Conflicts of Interest
Policy Approved: 15 August 2012
Policy Effective: 24 August 2012
I. PURPOSE AND SCOPE
Oregon State University (“University”) promotes and encourages new and varied collaborations with entities outside of the University. The University recognizes that as a result of such external relationships conflicts of interest may occur when an individual is in a position to make a decision in the conduct of his or her research, teaching or outreach activities that may result in personal or family gain, financial or otherwise. Adherence to the highest levels of professional integrity by faculty, staff, students and associated personnel in all their actions is required to avoid or minimize conflicts of interest.
This policy sets forth the obligations of Oregon State University and its employees, students and associated personnel with respect to conflicts of interest that involve University research.
What Is the Scope of the Policy?
This policy promotes objectivity in research by establishing expectations and disclosure requirements to ensure that conflicts of interest in research arising from external relationships will be identified and managed or eliminated. This Policy also reflects the requirements of two federal agencies, the U.S. Public Health Service (PHS) and the National Science Foundation (NSF), because their requirements are specifically established by agency regulation and policy.
In the event that ethical concerns or conflicts of interest not related to research are identified as a result of this Policy’s requirements, the Conflict of Interest Officer may refer the issue and relevant information to appropriate University officials.
Other laws and University policies also apply to interactions between University employees and entities external to the University; a list of such policies and their jurisdiction can be found under Additional Information in Section IX.
What Is a Research Conflict of Interest at OSU?
A research/financial conflict of interest (“Conflict of Interest”) occurs when the design, conduct or reporting of research could be directly and significantly affected by a Significant Financial Interest of an investigator (see Section II for definitions).
The university recognizes that members of our community encounter many types of conflicts of interest. Two examples of commonly encountered conflicts include procurement conflicts in which material goods are obtained non-competitively from a family business and professional conflicts in which one might be asked to provide an objective review of a manuscript or proposal prepared by a colleague, student, mentor, or recent collaborator. This policy does not apply to these types of conflicts. This policy pertains strictly to research/financial conflicts of interest.
This policy recognizes that relationships exist that could result in a Conflict of Interest. The intent of this policy is to identify such relationships and manage them by defining the boundaries within which Conflicts occur while allowing investigators to proceed with their research. The primary goal is to maintain objectivity in research by establishing standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a Significant Financial Interest of an investigator.
What Does the Policy Call For?
- Disclosure by investigators of outside activities and financial interests that create or appear to create Conflicts of Interest (see Section III).
- Review of disclosures by appropriate individuals and management or elimination of identified Conflicts of Interest (see Section VI).
- Training of investigators on this Policy, their responsibilities regarding disclosure, and federal regulations on Conflicts of Interest (see Section V).
- “Conflict of Interest” or “Conflict” means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of funded research.
- “Investigator” means any individual who is responsible for the design, conduct or reporting of University research.
- “Investigator” is not defined by faculty rank or title and can include any individual affiliated with University research.
- “Conflict of Interest Officer” or “COI Officer” means the person appointed by the Vice President for Research to review all disclosures and identify and resolve Conflicts of Interest.
- “Conflict of Interest Committee” or “COI Committee” means a committee made up of OSU faculty and staff appointed by the Vice President for Research and serving in an advisory capacity to the COI Officer.
- “Family” or “Family Member” means:
- the individual’s spouse or domestic partner
- the parents, children, and siblings of the individual or the individual’s spouse or domestic partner
- any person for whom the individual has a legal support obligation
- “Significant Financial Interest” means a financial interest consisting of one or more of the following interests of the individual and his or her family:
- Remuneration (salary and any other payment for service, e.g., consulting fees, honoraria, paid authorship, etc.) received from a single entity in the last 12 months valued at $5,000 or more;
- Any equity (stock, stock options or other ownership interest) valued at $5,000 or more in a single publicly traded entity;
- An aggregate of (a) and (b) that is $5,000 or more for a single publicly traded entity;
- Any equity in a non-publicly traded entity;
- Intellectual property rights and interests upon receipt of income related to such rights or interests.
Significant Financial Interest does not include (i) salary, royalties, or other remuneration from the University; (ii) income from investment vehicles, such as mutual funds or retirement accounts, where the individual or family members do not directly control the investment decisions; (iii) income from seminars, lectures, teaching engagements sponsored by, or service on advisory committees or review panels for, a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or (iv) the interests held by family members that are unknown to the individual.
On an annual basis, disclosure of outside activities and Significant Financial Interests via the Conflict of Interest Declaration Form (“Declaration”) is required by:
- Professorial faculty, Research Associates, and Post-Doctoral Fellows/Scholars
- Individuals who serve or intend to serve as an investigator on a sponsored project, including but not limited to Professional Faculty, Faculty Research Assistants, Senior Faculty Research Assistants, Instructors, and Emeritus, Courtesy and Visiting Faculty
- Other individuals as identified by the Conflict of Interest Officer, a college dean or unit head
The Declaration will solicit information that allows the University to determine whether the individual has a Conflict of Interest. Within the constraints imposed by state law, Declarations will be made a part of the employee’s confidential personnel record.
Individuals required to report annually must also update their Declaration within 30 days of discovering or acquiring a new Significant Financial Interest and when significant changes occur in the circumstances of a previously reported activity. In addition, any other individual engaged in research or with the intent to engage in research who has a Conflict of Interest must disclose the activity that gives rise to the Conflict of Interest when it first arises or is discovered.
Requirements Specific to Sponsored Research
Before submission of an application for funding, principal investigators must disclose to the University any Significant Financial Interests of any investigators on the project 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 or eliminate it.
Investigators who receive funding from the Public Health Service (PHS), including funding from the National Institutes of Health (NIH), must also report to the COI Officer the occurrence of any reimbursed or sponsored travel that is related to their institutional responsibilities unless the travel is reimbursed or sponsored by Federal, state or local government, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. The COI Officer may determine that additional information is needed, including a determination or disclosure of monetary value.
IV. REVIEW AND MANAGEMENT
The Conflict of Interest Officer or designee will review Declarations and other information considered relevant to evaluate whether a Conflict of Interest exists and to manage or eliminate the conflict. The COI Officer shall determine the appropriate resolution of a Conflict of Interest. In cases where a Conflict of Interest exists, a plan to eliminate or manage the Conflict will be created by the COI Officer with input by the investigator.
At the request of the COI Officer, the Conflict of Interest Committee or other individuals as identified by the COI Officer will advise the COI Officer on any issues of actual, potential, or perceived Conflicts of Interest.
The COI Committee will serve in an advisory capacity to the COI Officer and represent the diversity of academic and research/scholarship disciplines and administrative functions of the University. An Executive Committee of the COI Committee will be comprised of the Chair, Vice Chair, COI Officer and COI Administrator and will provide leadership for the COI Committee. Faculty members are appointed to the COI Committee by the Vice President for Research.
All individuals required to submit a Declaration on an annual basis must complete training on this Policy, their responsibilities regarding disclosure, and federal regulations on conflicts of interest. Investigators who receive funding from PHS must complete such training every four years; immediately when the University revises its Conflict of Interest Policy; when an investigator is new to the University; and when the University finds an investigator is not in compliance with this policy or an applicable management plan. All other individuals required to submit a Declaration on an annual basis must complete training at least once.
An employee may appeal a decision of the Conflict of Interest Officer to the Vice Provost for Academic Affairs. If the Conflict involves externally funded research, the Vice Provost for Academic Affairs will consult with the Vice President for Research.
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.
When sanctions result from a Conflict of Interest that includes an externally funded research or scholarship project, the University will take action legally required by the funding sponsor.
VIII. INSTITUTIONAL REQUIREMENTS FOR PHS AND NSF
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. The University will meet the requirements as defined in 42 CFR Part 50, Subpart F (Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought), 45 CFR Part 49 (Responsible Prospective Contractors), and the NSF Conflict of Interest Policies, Chapter V: Grantee Standards, Policies and Procedures Guide.
IX. ADDITIONAL INFORMATION
Questions about this Research Conflicts of Interest Policy should be directed to the COI Officer.
Other policies relating to conflict of interest that are applicable to University employees and investigators include:
- Employment & Supervision of Immediate Family Members Policy, OSU Office of Human Resources
- Employment of More than One Member of a Household Policy, OSU Office of Human Resources; Oregon Administrative Rules 580-022-0055
- Consulting, Overload and Outside Employment (Conflict of Commitment Policy), OSU Academic Affairs
- 104-001: Declaration of Conflict or Potential Conflict of Interest, OSU Procurement and Contract Services (PaCS) Policy & Procedure Manual
- Oregon Government Ethics Law, Oregon Revised Statutes, Chapter 244
- Higher Education potential conflict of interest, Oregon Revised Statutes, 351.067
- Outside Employment and Activities; Conflict of Interest, Oregon Administrative Rules 580-021-0025; State Board of Higher Education Internal Management Directive 4.011 and 4.015