I. Policy Statement

Federal regulations require universities to manage, reduce, or eliminate any actual or potential conflict of interest that may be presented by compensated outside activities and other financial interests of Investigators (as defined below) involved in cooperative agreements with, or sponsored research projects funded by, the National Science Foundation (NSF) and the Public Health Service (PHS). This policy is intended to fulfill those requirements.

Maintaining the public’s trust in research is of the utmost importance. It is vital that Investigators, the university, and federal agencies work together to promote and maintain objectivity in research. Responsibilities defined in this policy should be thoughtfully fulfilled and in compliance with all federal and institutional requirements. To this end, the identification and management of Investigators’ financial conflicts of interest is vital.

II. Coverage

This policy applies to all Investigators at the University of Puget Sound who apply for, or who receive research support or funding from, the NSF, agencies of the PHS, and any other research funder who incorporates PHS regulations into their policies. Provisions of this policy that apply to subrecipients of research support or funding from these same agencies can be found in Section VIII, Subrecipients.

III. Definitions

Designated Official. The Provost, Grant Manager, and/or other institutional designees as may be determined by the Provost, will serve as the individual(s) appointed by the university to solicit and review disclosures of Significant Financial Interests, including any related management plan, as applicable, from each Investigator who is planning to participate in, or is participating in, Federally Funded Research.

Family Member. An Investigator’s spouse, domestic partner, and/or dependent children.

Federally Funded Research. Research support or funding from the NSF, agencies of the PHS, and any other research funder who incorporates PHS regulations into their policies.

Financial Conflict of Interest. A Significant Financial Interest that the university reasonably determines could directly and significantly affect the design, conduct, or reporting of Federally Funded Research.

Investigator. The project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or educational activities under the terms of a federal grant or contract. This may include collaborators or consultants.

Institutional Responsibilities. An Investigator's professional responsibilities on behalf of the university, such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards.

Significant Financial Interest. The term Significant Financial Interest means:

  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of any Family Member) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
    1. Publicly Traded Entities. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    2. Non-Publicly Traded Entities. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or any Family Member) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
    3. Intellectual Property. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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. Disclosure shall include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
  3. Exclusions. Significant Financial Interest does not include:
    • Salary, royalties, or other remuneration paid by the university to the Investigator if the Investigator is currently employed or otherwise appointed by the university, including intellectual property rights assigned to the university and agreements to share in royalties related to such rights;
    • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
    • Income from seminars, lectures, or teaching engagements sponsored by 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
    • Income from 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.
    • Specific to grants awarded by the NSF, a Significant Financial Interest also does not include:
      • an equity interest that, when aggregated for the Investigator and the Investigator’s Family Member, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
      • salary, royalties, or other payments that, when aggregated for the Investigator and the Investigator’s Family Member, are not expected to exceed $10,000 during the prior twelve-month period.

IV. Disclosure Requirements for Investigators

  1. Initial Disclosures. Investigators must disclose any Significant Financial Interests (and those of any Family Member) to the university by completing the Federally Sponsored Research Financial Conflict of Interest Disclosure Form (“Disclosure Form”) no later than at the time of application for any Federally Funded Research. As further defined by NSF, such disclosures should include any Significant Financial Interests:
    1. That would reasonably appear to be affected by the research or educational activities funded or proposed for funding by a federal agency; or
    2. In entities whose financial interests would reasonably appear to be affected by such activities.
  2. Annual and Revised Disclosures.  During the period of the Federally Funded Research award, Investigators must also disclose any Significant Financial Interests (and those of any Family Member) to the university by completing an updated Disclosure Form:
    1. During the period of the award, at least annually by the anniversary of the submission of the original Disclosure Form; or
    2. Within 60 days of identification of a new Investigator participating in the project; or
    3. Within 30 days of discovering or acquiring a new Significant Financial Interest.

Such disclosure shall include any information that was not disclosed initially to the university pursuant to paragraph (IV)(1) of this section, or in a subsequent disclosure of Significant Financial Interests, and shall include updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest).

V. Review and Management of Financial Disclosures

1. Disclosure Review.
All Disclosure Forms completed by Investigators in accordance with sections IV (1) and (2) above shall be submitted to the Grant Manager for review as part of the initial grant application. Prior to the grant application being submitted, the Grant Manager shall review Disclosure Forms to determine whether a possible Financial Conflict of Interest exists, and notify the Provost of any possible conflict. If the Provost concurs with the Grant Manager’s determination that a conflict exists, the Grant Manager will determine what conditions or restrictions, if any, should be imposed by the university to manage, reduce or eliminate such Financial Conflict of Interest. This process is shown in more detail in the associated Federal Financial Conflict of Interest Policy Flow Chart for Responsibilities of the Designated Institutional Officials in Determining Whether a Financial Conflict of Interest Exists.

A Financial Conflict of Interest exists when the Designated Official reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of Federally Funded Research or educational activities. An Investigator's Significant Financial Interest is related to Federally Funded Research when the university, through its Designated Official, reasonably determines that the Significant Financial Interest:

  • Could be affected by the Federally Funded Research; or
  • Is in an entity whose financial interest could be affected by the research.

Training requirements to aid the Designated Official in determining whether a Financial Conflict of Interest exists are outlined in Section VII, Training.

2. Management of Financial Conflicts of Interest.
If the Designated Official determines that a Financial Conflict of Interest exists, the Grant Manager, together with the Investigator, will develop a proposed management plan to mitigate, reduce, or eliminate the conflict, which the Provost will review and approve. A management plan might include:

  • Public disclosure of Significant Financial Interests;
  • Monitoring of research by independent reviewers;
  • Modification of the research plan;
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
  • Disqualification from participation in the portion of the Federally Funded Research that would be affected by Significant Financial Interests;
  • Divestiture of Significant Financial Interests; or
  • Severance of relationships that create conflicts.

The Provost, or the institutional official designated by the Provost, will monitor Investigator compliance with the management plan on an ongoing basis until completion of the Federally Funded Research project.

3. Retrospective Review.
If the university determines that a Financial Conflict of Interest was not identified or managed in a timely manner, or if an Investigator has failed to comply with a management plan, the university will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the project to determine whether the activity conducted during the period of non-compliance was biased in the design, conduct, or reporting of the sponsored project. As part of its retrospective review, the university will document:

  • Project number;
  • Project title;
  • Project director or principal investigator;
  • Name of the Investigator with the Financial Conflict of Interest;
  • Name of the entity with which the Investigator has a Financial Conflict of Interest;
  • Reason(s) for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  • Findings of the review; and
  • Conclusions of the review.

Based on the results of the retrospective review, if appropriate, the university shall update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.

4. Sanctions.
Noncompliance or non-disclosure by an Investigator under this policy may initiate disciplinary proceedings in accordance with the university’s Faculty Code and Faculty Bylaws, and any other campus-wide policies or other applicable policies as appropriate.

 

VI. Reporting

  1. If the Designated Official determines that a Financial Conflict of Interest exists, they will report the Financial Conflict of Interest to the sponsoring agency within 60 days of identifying the Financial Conflict of Interest in accordance with guidelines provided by the sponsoring agency.
  2. If the Designated Official determines that bias exists within the design, conduct, or reporting of Federally Funded Research, they will notify the sponsoring agency promptly and will submit a mitigation report in accordance with relevant regulations.
  3. If the Designated Official determines that an Investigator’s failure to comply with this policy or a management plan as described in Section V(2) appears to have biased the design, conduct, or reporting of Federally Funded Research, they will notify the sponsoring agency promptly and take corrective action for noncompliance with the university’s policy and/or management plan.

 

VII. Training

Investigators covered by this policy are required to complete Financial Conflict of Interest training prior to engaging in sponsored research projects and every four years thereafter. Investigators may fulfill the training requirement by reviewing this policy and completing the Financial Conflict of Interest Training Module offered by CITI and providing a certificate of completion to the Designated Official via the grant submission process. An Investigator may also be required to repeat this training as part of a management plan. Investigators will be required to complete this training immediately if:

  • The university’s Financial Conflict of Interest policy changes in a manner that affects Investigator requirements;
  • The Designated Official finds an Investigator noncompliant with the university's Financial Conflict of Interest policy or management plan; or
  • An Investigator is new to the university.

The Designated Official as defined in this policy will also complete the CITI training and any other training as determined to assist them in determining what qualifies as a Financial Conflict of Interest.

VIII. Subrecipients

If the university carries out Federally Funded Research through a subrecipient, the subrecipient must have in place a Financial Conflict of Interest policy that complies with NSF and PHS regulations.

The university will incorporate, as part of a written agreement with the subrecipient, terms establishing that the subrecipient’s Financial Conflict of Interest policy applies to subrecipient Investigators. The agreement must specify time periods for the subrecipient to report all identified subrecipient research Financial Conflicts of Interest to the university, which shall be sufficient to allow the university to meet its reporting obligations to the sponsoring agency.

IX. Records Retention

The Grants Manager will retain all records created under this policy, including financial disclosures, conflict management plans, and related documents, for three years from the date the grant or contract to which they relate is terminated or completed, or until the resolution of any federal action involving those records, whichever occurs later.

X. Effective Date

This policy is effective as of January 5, 2022.

XI. Related Statutes, Regulations, and Policies

Policy Owner: Office of Finance

Date Adopted: January 5, 2022