General Conflict of Interest (COI) Policy for Grant-Funded Proposals

Policy Statement

A potential Conflict of Interest (COI) arises where an individual’s personal interests may compromise—or be seen as compromising—any externally funded research or activities. The University has an expectation that faculty and staff will carry out sponsored projects in a way that avoids or minimizes any actual, apparent or potential conflicts of interest.

Reason for Policy

The purpose of this policy is to inform faculty and staff about situations that generate conflicts of interest related to sponsored projects, provide mechanisms for faculty/staff and the University to manage those conflicts of interest that arise, and describe situations that are prohibited. The greater purpose is to protect the reputation of faculty/staff and preserve public trust in sponsored activities.

Who Must Comply

Each Investigator must comply with this policy. For the purposes of this document, the term Investigator means anyone responsible for the design, conduct or reporting of the activities funded, or proposed for funding, by an external sponsor, including the Primary Investigator (PI)/Project Director (PD), co-PI(s)/co-PD(s), and key personnel. The PI/PD is responsible for identifying the individuals who meet this definition with support from the Office of Sponsored Programs and Foundation Relations (OSPFR).

Responsibilities

Each Investigator must complete Conflict of Interest training offered through CITI and submit a General Financial Conflict of Interest (FCOI) disclosure form before an application for external funding can be submitted to the relevant agency/sponsor, as well as on an annual and ad hoc basis. Recertification in Conflict of Interest training is required every 4 years.

The PI/PD will work with the OSPFR to determine who fits the definition of Investigator and therefore needs to complete a COI training course and the disclosure form. Per federal guidelines, all Investigators are also responsible for disclosing any relevant financial interests of his/her spouse or domestic partner and/or dependent children on the FCOI disclosure form. It is the responsibility of the PI to ensure that all key personnel complete COI training.

Release of funding for successful grant applications will be contingent upon all Investigators complying with the above guidelines. In addition, if a situation later arises that raises questions of conflict of interest, the Investigator must inform the OSPFR, who will inform the provost.

For research sponsored by the U.S. Public Health Service (PHS), Fisher’s PHS/NIH Financial Conflict of Interest policy will apply.

Disclosure

Each Investigator (as defined above) is required to disclose the following Significant Financial Interests:

Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.

Regardless of the minimum disclosure requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

Each Investigator who has a Significant Financial Interest requiring disclosure shall submit all required supporting documentation to the OSPFR, who will then forward it to the provost for review. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential.

As required by Federal regulation, all Significant Financial Interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

Review Process

A Significant Financial Interest (SFI) is not automatically determined to be a conflict of interest. If an SFI is identified in the disclosure form, the OSP will forward the form and any accompanying confidential documentation to the provost or designee and the University's legal counsel as needed. As the University's designated financial disclosure officer, the provost will review the form and the accompanying documentation, as well as the legal counsel’s recommendations, to determine whether any SFI relates to the sponsored project and whether a financial conflict of interest exists. If the provost must consult with administrative colleagues, he or she will take steps to protect the confidentiality of the information.

A conflict of interest exists when the review reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. If a financial conflict of interest exists, the provost and Investigator will develop conditions or restrictions that should be imposed by the University to manage, reduce or eliminate it (collectively, a “management plan”).

Managing Conflicts of Interest

Actual or potential conflicts of interest will be managed, reduced or eliminated in accordance with the above guidelines.

Following a review of the Disclosure materials, the provost, with guidance from legal counsel as needed, may impose additional conditions or restrictions, including, but not limited to, the following:

Modification of the research plan;
Disqualification from participation in all or a portion of the research funded;
Divestiture of significant financial interests; or
Severance of relationships that create actual or potential conflicts.

The provost may require that a plan for reducing or eliminating conflicts of interest be incorporated into a Management Plan between the University and the Investigator. All reports regarding the conflict of interest (if required) will be submitted to the sponsor prior to the expenditure of funds under an award.

The OSPFR, in conjunction with the provost, will monitor Investigator compliance with the management plan on an ongoing basis until the completion of the funded project. Generally, if a financial conflict of interest cannot be resolved, the agency/sponsor must be notified.

Investigator Non-Compliance

If it is determined that an Investigator has violated this policy or the terms of any resolution plan (including failure to file or knowingly file incomplete, erroneous or misleading disclosure forms), the provost will be responsible for the provision of sanctions in accordance with University and Board of Trustees policies. These sanctions will be in addition to any penalties that may be imposed by a Federal or State agency for infractions that also violate the terms or conditions of award.

The provost’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the provost, will be described in a written explanation of the decision to the Investigator and, where applicable, the individual will have the right to appeal the decision.

Record Retention

To comply with both federal and University policy, financial disclosure forms and all actions taken by the University with respect to each conflicting interest will be kept for three (3) years after the report is submitted for the sponsored project or until resolution of any action by the sponsor, whichever is longer. Their official repository is the OSPFR.

Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be kept confidential by the Office of Sponsored Programs and Foundation Relations, the Office of the Provost, and the University. However, the University or the prime awardee may make such information available to an agency funding an Investigator’s research, to a requestor of information concerning financial conflict of interest related to funding or to the primary entity that made the funding available to the University, if requested or required. If the University provides any of this information to an outside entity, the Investigator will be informed.

Collaborative Projects/Subagreements

Collaborators/sub-recipients/subcontractors from other organizations must either comply with this policy or provide a certification that their organizations are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies.

Definitions

Family: Any member of the Investigator’s immediate family, specifically spouse or partner and/or any dependent children.

Financial Conflict of Interest (FCOI): A Significant Financial Interest (or, where the provost requires disclosure of other Financial Interests, a Financial Interest) that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of sponsored projects.

Financial Interest: Anything of monetary value over $100 received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.

Financial Interest does NOT include:

Salary, royalties or other remuneration from the University; or
Income from seminars, lectures or teaching engagements sponsored by public or non-profit entities; or
Income from service on advisory committees or review panels for public or nonprofit entities; or
Equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions.

Significant Financial Interest (SFI): Anything of monetary value over $100 that would reasonably appear to affect the sponsored project or its results, including, but not limited to:

Salary or other payments for services from an outside entity (e.g., consulting fees or honoraria). This does not include grant funds paid to you through St. John Fisher University.
Equity interests (e.g., stocks, stock options or other ownership interests), valued, as of the date of disclosure combined with any remuneration in the past 12 months, at more than $100.
Intellectual property rights (e.g., patents, copyrights, trademarks, trade secrets, and/or any royalties from such rights), valued, when aggregated for the Investigator (including his/her spouse and dependent children), at more than $100.
A fiduciary or management role (e.g., as a board member, director, officer, partner, trustee, employee, or consultant) for a sponsor, vendor, or (sub)contractor related to the sponsored project.

Institutional responsibilities: The Investigator’s responsibilities on behalf of St. John Fisher University, which are defined by the University as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards (e.g., IACUC, IRB, etc.).

Investigator: Any individual who is responsible for the design, conduct, or reporting of a project or project proposal, including the principal investigator, co-principal investigator, key personnel, and any other person who may be independently responsible for or significantly influences the design, conduct or reporting of the project. For the purposes of the Financial Conflict of Interest disclosure form and Conflict of Interest policy, “Investigator” includes the Investigator’s spouse or domestic partner and/or any dependent children.

Key Personnel: Individuals who contribute to the scientific development or execution of a project in a substantive measurable way. The principal investigator/program director (PI/PD) is always considered senior/key personnel.

Research: A systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).

This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.

Approved May 2019
Last Updated July 2021
Next Review Fall 2023