Policy Approved: August 17, 2017
Policy Effective: August 31, 2017
Last Updated: March 4, 2022

 

I.   POLICY STATEMENT

This policy sets forth the obligations of Oregon State University and its employees, students, and affiliates (“individuals”), with respect to financial conflicts of interest that involve university-affiliated research and sponsored project activities.

The university encourages professional collaborations with individuals, companies, and other entities (“entities”) external to the university. Such external relationships can further the university’s commitment to excellence in research, education, and engagement, but may also result in conflicts of interest.  A conflict of interest arises when an individual’s external interest(s) may, or could appear to, bias or unduly influence their decision-making during university work, or compromise their ability to fulfill their obligations to the university.

This policy seeks to maintain objectivity across the lifespan of university research so that the design, conduct, outcomes, and reporting of university-affiliated research will not be biased, or perceived as biased, because of financial interests held by a researcher or their family members.  Researchers are to conduct their affairs so that they recognize possible financial conflicts of interest, disclose them promptly to the university, and maintain their affairs so that they avoid or minimize conflicts of interest when they could or do exist.

Every researcher has an obligation to become familiar with and abide by the provisions of this policy. Questions about financial conflicts of interest in research should be directed to the Research Conflict of Interest (RCOI) program office.

OSU researchers are to initially manage potential research conflicts of interest by remaining current with the following requirements:

•    Training. Researchers are to complete initial and ongoing training on this policy, their University responsibilities, and the federal regulations covering Financial Conflicts of Interest in Research (see Section V).

•    Disclosures. Researchers are to submit initial, ad-hoc, and annual disclosures of external financial interests that may constitute a Significant Financial Interest (see Section IV).

The Research Office and supervisors are to review isclosures and as appropriate, manage, reduce, or eliminate Research Conflicts of Interest (see Section VI).

 

II. EXPECTATIONS and STANDARDS OF CONDUCT

OSU research is to be conducted with high professional standards and expectations for integrity. The standards of conduct below do not encompass all possible situations that could occur but should underpin the activities of OSU researchers.
 
1.    Individuals should not accept other employment or engage in external professional activities that would:
a.    Unduly influence their independent judgment as they perform university-affiliated work; or
b.    Require them to disclose confidential information acquired during their university work, to an external entity.

2.    Individuals should not disclose or use confidential information acquired during their university work to further their personal or financial interests.

3.    Individuals should not engage with an external entity if they have a financial interest in that entity that could reasonably conflict with their research or university responsibilities.

4.    Individuals should abstain from investing in entities that could benefit from decisions they could make as a representative of the university.

5.    Individuals should not accept benefits, remuneration, gifts, loans, or otherwise engage with an entity, if circumstances would reasonably infer that those benefit(s) could unduly influence or reward decisions that they could make during university work.

 

III.   SCOPE

This policy applies to all individuals (termed “researchers” or “investigators,” see definitions in Sect. IV) who are materially involved with university-affiliated research activities such as those described in protocols, proposals, studies, awards, or other research activity agreements. This policy is based on the requirements of the U.S. Public Health Service regulation and the National Science Foundation policy as they apply to their grantee institutions. These requirements promote objectivity in research by requiring that significant financial interests which arise from relationships with entities external to the university are disclosed to the university by the investigator with the financial interest, and managed, reduced, or eliminated as appropriate to reduce the risk of bias in research and related activities affiliated with the university.

This policy does not address other types of conflicts of interest that may arise for individuals affiliated with the university. Other laws and policies may apply to interactions between OSU employees and entities that are external to the university.

What Is a Research Conflict of Interest at OSU?
A financial conflict of interest in research (“Research Conflict of Interest” or “Research Conflict”) arises when university-affiliated research could be directly and significantly affected by a financial interest held by an investigator or their family member(s) (see Sect. IV for definitions). Such financial interests often arise from collaborations and relationships between extenral entities and university members involved in research.  

Examples of possible research conflicts include, but are not limited to:

  • Provision of funding, materials, products, or other support for university research from an external entity in which investigators or their family members have a financial interest.
  • Receipt of payments from an external entity that may be interested in or related to your research.
  • Holding or selling stock or stock options in an external entity that may be interested in or related to your research.
  • Holding a position in an external entity that may be interested in or related to your research.
  • Using university resources to benefit an external entity.

 

IV.   DEFINITIONS

Aggregate value means the consolidated and summed total, in U.S. dollars, received from a single entity (i.e., remuneration, equity interests, sponsored travel, gifts, etc.) by the discloser and their family member(s).  

Disclosure means submitting a completed or updated university disclosure form for external financial interests related to research.

Equity means owning shares or stock, or receiving or holding any other type of ownership interest in an entity.

Entity means any person, business, company, organization, institution, agency, or government (other than the U.S. federal government). An entity may be U.S.- or non-U.S.-based, privately- or publicly-held, or hold a for-profit or non-profit tax status.

  • “Private entity” refers to a business with stock or other ownership interests which cannot be bought or sold by the public
  • “External entity” refers to any entity other than Oregon State University.
  • “Foreign entity” refers to any business, organization, agency, university, government, or other entity that is not registered or incorporated to do business in the U.S.

Family Member(s) means an Investigator’s spouse or domestic partner, and any dependent child(ren).

Financial Interest means anything of economic value held or received by an Investigator or their Family Member(s), originating from an Entity (other than Oregon State University) regardless of whether the dollar value is readily available or ascertainable.

Financial Interests include, but are not limited to:

a)    Remuneration
b)    Equity or other ownership interests (e.g., stocks, stock options) in an Entity
c)    Intellectual property rights and interests (e.g., patents, trademarks, copyrights)
d)    Sponsorship or reimbursement of travel- and lodging-related expenses

Financial Interests do not include:

a)    Remuneration received directly from Oregon State University for carrying out University responsibilities
b)    Remuneration received for Investigator-provided seminars, lectures, teaching engagements, or services provided to advisory committees or review panels, when provided by: U.S. Federal, state, or local governmental agencies; or, U.S. institutions of higher education and their affiliated research institutes, academic teaching hospitals, and medical centers located within the U.S.
c)    Income or equity held in investment vehicles such as mutual funds or blind trusts, where the Investigator and their Family Member(s) do not directly control the decisions made in those investment vehicles.

Management plan means an appropriately reviewed and signed document that describes actions taken or that must be taken, to address a Research Conflict of Interest.

Outside or External Professional Activities means those activities undertaken and performed, outside of an Investigator’s University responsibilities, that utilizes their professional skills and expertise.

Remuneration includes salary, payments for services, in-kind benefits; or receipt of cash, gifts, sponsorship, reimbursements, advances, loans or loan forgiveness, or other types of compensation.

Research encompasses basic research, applied research, and experimental development; and the education and training of others in basic and applied research and experimental development.

Research Conflict of Interest (RCOI) means the existence of a Significant Financial Interest which could directly and significantly affect the design, conduct, outcomes, or reporting of Research affiliated with the university.  RCOI is the university equivalent to the regulatory definition of Financial Conflict of Interest (FCOI).

Research Conflict of Interest Officer (RCOI Officer) is the Institutional Official who determines whether a Research Conflicts of Interest exists, and directs the implementation of a Management Plan to address it appropriately.

Researcher (or Investigator) means an individual who contributes, or is expected to contribute, to a significant aspect of the design, conduct, outcomes, or reporting of research & development projects affiliated with the university. Principal investigators and senior/key personnel who seek or receive support for OSU-affiliated research activities and programs are always Investigators under this policy, as well as any others who meet the definition above.  An active investigator is one who meets the definition above for one or more OSU-affiliated proposals or awards that have not been closed out, or are otherwise active.

Significant Financial Interest (SFI) means financial interests in an entity that (1) are related, or appear to be related, to the Investigator’s research or university responsibilities; and (2) were received or held by the Investigator or their family members during the 12 months prior to disclosure; and when aggregated across the Investigator and their family members, and for the duration of the previous year, (3) meets one of the thresholds below:

a)    Any amount of Equity in a privately-held Entity
b)    $5,000 USD or more of Equity in a publicly-traded Entity
c)    $5,000 USD or more of Remuneration from an Entity
d)    $5,000 USD or more of Financial Interests and Equity received by or held in an Entity

If there is any question about whether a SFI could be related to an Investigator’s Research or University responsibilities, then that SFI must be disclosed so the RCOI program office can make a determination.

Training means completion of the university-approved RCOI course (1) upon initial identification as an Investigator, (2) least every four years thereafter, and (3) otherwise upon request by the RCOI Officer, a supervisor, or other university official. This fulfills the training standard described in the U.S. Public Health Service regulation on Financial Conflicts of Interest in Research. More information about university-approved RCOI training can be found here.

University responsibilities means the Investigator’s obligations and responsibilities associated with their university appointment; for example, activities involving research and research consultation, teaching, advising, clinical or professional practice, administrative duties, university service on committees and panels, and university-based outreach and engagement.
 

V.   REQUIREMENTS FOR DISCLOSURE OF FINANCIAL INTERESTS

Investigators are required to disclose their external financial interests to the university accurately, completely, and promptly to the RCOI program for review and assessment of any Significant Financial Interests. 

An Investigator must disclose initially:

•    Within 30 days of university appointment, when the investigator expects to contribute to one or more active research proposals or awards within the first year, or
•    Prior to submission of their first research proposal as an Investigator, or
•    Upon request by the RCOI Program Office or the RCOI Officer, their supervisor, or other university official.

Thereafter, Investigators must complete their research disclosure to the university:

•    Within 30 days of discovering or acquiring a new SFI,
•    On an annual basis, whether or not they have any financial interest(s) to disclose, and
•    Upon request by the RCOI Program Office or the RCOI Officer, their supervisor, or other university official.

Investigators are to disclose their external financial interests to the RCOI program using the university’s online disclosure form, available here.

During review, additional information may be requested in order to determine whether an SFI or RCOI exists, and if so, determine how to reduce, manage, or eliminate the conflict(s). Additional information may be gathered from the Investigator, and from other sources such as university websites, research-related websites, external entity websites, and publicly available databases, on an as-needed basis.   

Some conflict of interest information must be made publicly accessible per PHS requirements. Upon written request, the university will provide necessary information regarding Significant Financial Interest(s) held by Investigators of NIH-funded research projects when the university determines that (1) the SFI(s) are related to NIH-funded projects, and (2) the SFI(s) are Research Conflicts of Interest.

 

VI.   TRAINING

All Researchers must complete university-approved training on this policy and the underlying federal regulations:

•    Initially upon appointment or qualification as an active Investigator, and
•    At least once every four years thereafter.

This training describes regulatory and policy requirements, Investigator responsibilities to the university and to research sponsors, and provides examples of conflict of interest scenarios.  The current Research COI training module is available online, and a link is provided for convenience here.

 

VII.   REVIEW AND MANAGEMENT

Review. The RCOI program office initially reviews Investigator disclosures and their research activities, on behalf of the university, to reasonably determine whether an Investigator has an SFI that could:

1.    Be affected by their university research,
2.    Affect the external entity’s financial interests, or
3.    Unduly affect or bias university research.

The RCOI Officer may identify additional individuals to advise on complex or novel issues of actual, potential, or perceived Research Conflicts of Interest, such as representatives from OSU Advantage, Sponsored Research and Award Administration (OSRAA), Faculty Affairs and Human Resources, Export Control, the Graduate School, or other relevant units. If there is a possible conflict of interest but the conflict is not a Research Conflict of Interest, the review will be referred to the individual’s supervisor and appropriate administrative unit, as applicable.  

When the RCOI program identifies an actual or potential Research Conflict of Interest, the scenario is further reviewed to determine what conditions or restrictions may be required to reduce, manage, or eliminate the research conflict.

Management. The RCOI program office drafts a management plan, when necessary, that describes how the Researcher is to manage, reduce, or eliminate the Research Conflict of Interest.

Examples of conditions that could be applied include but are not limited to:
1.    Disclosing the potential conflict to appropriate audiences;
2.    Monitoring of research for undue influence or bias from financial interests;
3.    Modification of research plans that reduces or eliminates the ability of financial interests to affect the research;
4.    Reduction or modification of a researcher’s participation in affected research;
5.    Reduction or modification of a researcher’s duties or appointment;
6.    Partial or complete divestiture of the researcher’s significant financial interest(s); or
7.    Severance of relationships that create the conflict(s).

The management plan is reviewed and signed by the Researcher, their academic supervisor and dean, and the RCOI Officer. Supervisors oversee the implementation of a management plan for researchers who report to them, and Researchers are responsible for managing their conflict(s) in accordance with the terms of their current conflict management plan.

VIII.   ENFORCEMENT

Failure to comply with this policy may lead to disciplinary action, up to and including termination of appointment in accordance with applicable disciplinary procedures. Possible violations that may lead to disciplinary action include, but are not limited to:


1.    Failure to complete required training or disclose in a timely manner;
2.    Failure to fully disclose a potential conflict;
3.    Failure to fully comply with a required conflict management plan;
4.    Failure to respond to inquiries from the RCOI program office or Officer.

Researchers will receive automated reminders to submit their disclosures and complete their training. The RCOI program office may notify researchers with significantly delinquent disclosures or trainings and request that they complete their obligations. The RCOI Officer will provide a final notification of delinquency and indicate the potential consequences of inaction. The RCOI Officer may, as the Institutional Official, suspend relevant activities or impose other sanctions to help resolve the Research Conflict of Interest(s), or noncompliance with policy and program obligations.

Examples of actions or sanctions that could be applied include but are not limited to:


1.    Requiring the completion of additional training or coursework regarding conflicts of interest
2.    Involvement of a relevant supervisor
3.    Review of whether the research was biased in its design, conduct, outcomes, or reporting
4.    Review of whether information about the research was inappropriately shared with one or more external entities
5.    Notification of Research sponsor(s) regarding policy noncompliance and university plan to resolve the issue(s)
6.    Suspension of researcher from participating on one or more Research project(s)
7.    Suspension of a researcher from submitting additional Research funding applications
8.    Recommendation of disciplinary action(s), including postponement of promotion activities, suspension of employment, or termination from the university

If sanctions are imposed on an Investigator because they failed to comply with: (1) this policy, (2) their current RCOI management plan, or (3) a decision made by the RCOI Officer, then a written explanation will be provided to the Researcher and their supervisor(s).
 

IX.   INSTITUTIONAL REQUIREMENTS FOR PHS and NSF

The Public Health Service (PHS) of the U.S. Department of Health and Human Services (DHHS) and the National Science Foundation (NSF) have specific requirements regarding identification, disclosure, and resolution of financial conflicts of interest that arise in research. The university will meet these sponsor requirements as defined in 42 CFR Part 50, Subpart F (Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, or “FCOI Regulations”) and in NSF’s current Proposals and Award Policies and Procedures Guide (PAPPG) by the implementation and enforcement of this policy.

 

X.   RECORDS


The RCOI program office is responsible for the receipt, processing, review, and retention of RCOI disclosures and related records, and follows the university’s policies for Data Management and Classification and Records Retention.  


XI. CONTACT INFORMATION


Research Conflict of Interest program office: https://research.oregonstate.edu/coi
coi@oregonstate.edu

University Ethics and ethics advisor: https://leadership.oregonstate.edu/oarc/ethics

Accountability and Integrity Hotline: https://leadership.oregonstate.edu/oarc/report-concerns-hotline


XII. ADDITIONAL RESOURCES


Additional information on financial conflicts of interest in research, and other types of conflicts of interest may be found here:
•    Ethics and Conflicts of Interest: https://leadership.oregonstate.edu/oarc/ethics
•    University Code of Ethics: https://policy.oregonstate.edu/policy/university-code-ethics
•    Faculty Appointments and Service, 0200 HRM, Conflict of Commitment and Conflict of Interest:  https://hr.oregonstate.edu/manual/200-faculty-appointments-and-service
•    Conflicts of Interest in Research at OSU: https://research.oregonstate.edu/coi
•    Procurement Ethics and Conflicts of Interest at OSU: https://fa.oregonstate.edu/pacs-manual/100-purchasing-and-contract-ethics
•    Global Engagement Compliance at OSU: https://research.oregonstate.edu/global-engagement-compliance
•    Employing Household Members: https://policy.oregonstate.edu/policy/employing-household-members-faculty
•    Oregon Government Ethics Law, Oregon Revised Statutes, Chapter 244
https://oregon.public.law/statutes/ors_chapter_244
•    Oregon Government Ethics Commission: Guide for Public Officials, based on ORS 244
Updated 04/30/2021: https://www.oregon.gov/ogec/Pages/Guide-for-Public-Officials.aspx
•    Oregon Public Universities, Sources of compensation for officers and employees, potential conflict of interest, Oregon Revised Statutes, 352.232
https://oregon.public.law/statutes/ors_352.232
•    NSF Proposals and Award Policies and Procedures Guide (22-1) – Grantee Standards
https://www.nsf.gov/pubs/policydocs/pappg22_1/pappg_9.jsp
•    Federal regulations regarding project funding from the Public Health Service (PHS)
42 CFR Part 50, Subpart F (Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, or “FCOI Regulations”),
45 CFR Part 49 (Responsible Prospective Contractors)