PHS/NIH Conflict of Interest Policy


The Department of Health and Human Services amended its regulations related to financial disclosure on 8/25/2011. All institutions applying for U.S. Public Health Service (PHS) funding for research projects are required to have a policy that complies with the updated regulations.

This policy is instituted in addition to St. John Fisher University's General Conflict of Interest Policy, which addresses sponsored projects not funded by the PHS.

Policy Statement

A potential Conflict of Interest (COI) arises where an individual’s personal interests may compromise—or be seen as compromising--his/her professional obligations to the University, including those obligations related to 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 minimize any actual, apparent or potential conflicts of interest. This policy discusses conflicts of interest in relationship to sponsored projects funded by PHS (including the NIH).

Reason for Policy

Uniform Guidance §75.112 stipulates that HHS, NSF and other awarding agencies must establish conflict of interest policies for Federal awards. In addition, institutions applying for PHS-funded research must ensure that their Conflict of Interest policy is aligned with 42 CFR, Part §50, Subpart F, which outlines the responsibility of grant applicants for promoting objectivity in PHS-funded research.

The purpose of this policy is to inform faculty and staff about situations that generate conflicts of interest related to professional obligations—including sponsored projects—as well as to 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).


Each Investigator must complete Conflict of Interest training and submit a PHS/NIH 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. This applies whether Fisher is the prime recipient or the subrecipient of a sponsored project. Recertification in Conflict of Interest training is required every four years.

The PI/PD will work with the Office of Sponsored Programs and Foundation Relations 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.


Investigators provide the following information for all Significant Financial Interests: name of the entity, nature of the financial interest, the monetary value of the financial interest or its approximate value, and any supporting documentation needed to make a determination of whether a FCOI exists.

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.

Annual Disclosures

All Investigators must disclose their Significant Financial Interests to Fisher, through the OSPFR, at least annually during the grant period in conjunction with filing the required annual grant report to the sponsor.

Ad Hoc Disclosures

In addition to annual disclosures, certain situations require ad hoc disclosures.

New Hires

All Investigators involved with PHS-funded research must disclose their Significant Financial Interests to Fisher, through the OSPFR, within thirty (30) days of being appointed or employed.

New Significant Financial Interest

All Investigators must submit an ad hoc disclosure of any Significant Financial Interest they acquire during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.


Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined at the end of this document within the definition of Financial Interest. Such disclosures must be submitted within thirty (30) days of the date of travel and include, at a minimum, the purpose of the trip, the start and end dates, the sponsor/organizer, the destination, and, if known, the monetary value. The provost, in consultation with the Office of Sponsored Programs (OSPFR), will determine if additional information is needed to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s PHS-sponsored research.

Review Process to Determine if a Financial Conflict of Interest Exists

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 OSPFR 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 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;
  • Public disclosure of financial conflicts of interest;
  • Appointment of independent monitor(s) capable of taking measures to protect the design, conduct and reporting of the sponsored research against bias resulting from the financial conflict of interest;
  • Change of personnel or personnel responsibilities;
  • Disqualification from participation in all or a portion of the research funded;
  • Reduction or elimination of the financial interest (i.e., sale of an equity interest); and
  • Severance of relationships that create actual or potential conflicts.

The OSPFR, in conjunction with the provost, will monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded project.

To address complex situations, oversight committees may be established by the provost to periodically review the ongoing activity, to monitor how the activity is conducted, to ensure open and timely dissemination of the project results, and to otherwise oversee compliance with the management plan.

Reporting to PHS

Before expending any funds under an PHS funded grant, cooperative agreement, contract, or subaward under which the prime award is funded by a PHS entity, Fisher must report to the applicable PHS funding agency (or to the prime awardee) the existence of any FCOI or non-compliance as defined above in this policy and assure that the University has implemented a management plan in accordance with the FCOI regulations. If the funding for the research is a subaward from a prime PHS-awardee, reports shall be made to the prime awardee such that they may fulfill their reporting obligations to the PHS.

If an FCOI is identified and eliminated prior to the expenditure of any PHS- awarded funds, Fisher is not required to submit a FCOI report to the respective agency.

Investigator Non-Compliance

Disciplinary Action

In the event of an Investigator’s failure to comply with this Policy, the provost may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the provost is implemented.

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 IRB or IACUC, and will notify the individual of the right to appeal the decision.

Retrospective Review

If the provost determines that a FCOI was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a FCOI, the provost, with the assistance of a committee, will conduct a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in its design, conduct, or reporting. The retrospective review will take place within 120 days of the determination of a case of non-compliance.

Documentation of the retrospective review must include, at minimum, the following elements: Project number; project title; PI/PD; name of Investigator with the FCOI; name of the entity with which the Investigator has the FCOI; reason(s) for the retrospective review; detailed methodology used to conduct the retrospective review; findings of the review; and conclusions of the review.

The OSPFR will update any report previously submitted to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the OSPFR will include a mitigation report in accordance with PHS regulations, including a description of the impact of the bias on the research project and the plan of action to address this impact.

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 final expenditure report is submitted to the PHS or to the prime PHS awardee. Their official repository is the OSPFR.


To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential by the provost, OSPFR, and the University. However, the University or the prime PHS 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 PHS 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.

Public Accessibility

Prior to the expenditure of funds, the Institution will ensure public accessibility of information about any FCOI, via response to any requestor within five business days of a request, information concerning any Significant Financial Interest that meets the following criteria:

  • The Significant Financial Interest was disclosed and is still held by the Investigator;
  • A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and
  • A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.

The information to be made available shall be consistent with the requirements of the PHS federal policy and guidelines, including the following:

  • Investigator's name;
  • Investigator's title and role with respect to the research project;
  • Name of the entity in which the SFI is held;
  • Nature of the SFI; and
  • Approximate dollar value of the SFI (dollar ranges are permissible).

Collaborative Projects/Subagreements

Collaborators/subrecipients/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.


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.

For PHS Investigators, Financial Interest also includes any reimbursed or sponsored travel from international institutions of higher education, professional societies, and businesses undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator rather than reimbursed. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.

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 acquired over the preceding 12 months 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.
Public Health Service (PHS): The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the National Institutes of Health (NIH) and the Centers for Disease Control (CDC).

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