Policy

Conflict of Interest Policy for External Funding

1.00 Purpose

The purpose of this policy is to outline an institutional approach (applicable to the University and its auxiliaries) to the identification and management of conflicts of interest related to institutional responsibilities and external funding, in a fashion which will foster both the conduct of scholarly activities and ensure compliance with federal and state regulations. Throughout scholarly activities there is the potential to encounter possible conflicts of interest, real or reasonably perceived by others, which when disclosed to the University can further improve credibility and trust with sponsors, the research community, and within our local community. 

This policy is deemed to be consistent with the University's commitment to the principles, goals, and ideals described in the Cal State Monterey Bay Founding Vision and its core values.

2.00 Introduction

Cal State Monterey Bay encourages campus personnel to engage in a variety of scholarly and creative activities, including those leading to external funding or income from public agencies, private entities and individuals, and entrepreneurial ventures. At times, such activities may create situations that lead to potential or real instances of conflict of interest. The University recognizes the obligation of individuals and the institution to ensure that instances of conflict of interest do not improperly affect university activities, including those conducted through auxiliary organizations. Cal State Monterey Bay shall identify and address potential conflicts of interest that may arise among campus personnel proposing or engaging in externally funded activities. This policy applies to awards received directly from the designated sponsors or as a pass-thru award.   

This policy conforms to State of California (CA Government Code 87300) and federal government laws and regulations relating to conflicts of interest. In addition, this policy seeks to align with research standards established by organizations such as the Council on Governmental Relations (COGR), the American Medical Association (AMA), and the Office of Research Integrity (ORI) which include non-monetary conflicts and foreign support in their consideration of potential conflicts of interest.

3.00 General Principals

Cal State Monterey Bay has a responsibility to manage, reduce, and/or eliminate any actual or potential conflicts of interest involving activities conducted under the authority of the University or its auxiliary organizations. Therefore, Cal State Monterey Bay requires personnel to disclose any interests, as defined below, that may present an actual or potential conflict of interest in the conduct of any sponsored activity--meaning all activities conducted through such mechanisms as grants, contracts, and other means. Specifically, the University seeks to ensure that such activities will not be compromised by any interests that will or may be reasonably expected to bias the design, conduct, or reporting of any such activities.

4.00 Definitions

Business: Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint-stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.

Conflict of Interest (COI): A conflict of interest occurs when a divergence develops between an individual's private interests and their professional obligations to the University or its auxiliary organizations such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. Reviewer(s) of disclosure statements may identify actual or potential conflicts of interest when it is determined that a private interest of the investigator could directly or significantly affect the design, conduct, or reporting of activity(ies) funded or proposed for funding. Each investigator shall disclose all interests of personal gain that would reasonably appear to affect or be affected by the proposed activities. 

Institutional Official (IO): The individual within the University that is responsible for ensuring that the University complies with all research requirements, including the review of disclosures of potential conflicts of interests. The IO may designate the review of compliance activities to the Compliance Officer or Ad Hoc Independent Review Committee (IRC) as needed.

Institutional Responsibility: Institutional Responsibility is defined as teaching/education, research, outreach, clinical service, training, University and public service done on behalf of the University and directly related to those credentials, expertise and achievements upon which the Investigator’s position is based. This will generally include consulting, expert witness testimony, and institutional committee memberships, and service on panels such as Institutional Review Boards, or Data and Safety Monitoring Boards.

Investigator:  Includes the principal investigator (also known as Project Director), co-principal investigator(s), and any other member of the campus community who is responsible for the design, conduct, or reporting of activities proposed for funding or funded by an external source. The latter includes funds provided by grants and contracts and other means.  In this context, "Investigator" includes the investigator's immediate family, specifically, any dependent children, spouse or domestic partner. For the purposes of this policy, investigators also may include subcontractors where the foregoing definition may apply.

Financial interest refers to anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees, honorariums, etc.), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

Financial Interests:  

A financial interest is anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees, honorariums, etc.), equity interests (e.g., stocks, stock options, or other ownership interests), intellectual property rights (e.g., patents, copyrights, and royalties from such rights) and sponsored travel. 

Financial interest may be defined in different ways, depending on the entity and/or source of funding.  The most significant difference in definition exists in relation to nongovernmental vs. governmental funding sources. Criteria for each section are as follows:

Nongovernmental Funding Sources:
Investigators who are awarded grants from non-governmental sponsors, must complete the Chancellor’s Office Conflict of Interest training program and complete the Statement of Economic Interest CA Form 700-U. Additional non-governmental financial COI requirements are detailed in FPPC Form 700-U (2024/2025).

Governmental Funding Sources:
In relation to governmental funding source(s) a Significant Financial Interest (SFI) is defined as any financial interest that a principal investigator would have that: (1) would reasonably appear to be directly and significantly affected by sponsored activities or (2) any interest that a principal investigator would have in entities whose financial interest would reasonably appear to be directly and significantly affected by sponsored activities.

The following are SFIs which must be disclosed:

    1. Any income or other payment for services related to your institutional responsibilities (e.g., research, research consultation, teaching, professional practice, expert witness, advisory board membership, etc.) received within the previous 12 months which exceeds $5,000, including services completed during Sabbatical or Difference of Pay. 
    2. Publicly traded equity owned or acquired within the previous 12 months in any Publicly Traded Entity, the value of which exceeds $5,000. This includes any stock, stock options, or other ownership interest. 
    3. Any payments received for any intellectual property rights and interests (e.g., patents, copyrights, trademarks, assigned or licensed to a party other than the Regents and excluding academic or scholarly works) within the previous 12 months which exceeds $5,000.
    4. Travel reimbursement or payment by any entity within the past 12 months the value of which is equal to or exceeds $5,000. Payments from federal, state or local governments, U.S. institutions of higher education, or a research institute, academic medical center or hospital affiliated with U.S. institutions of higher education are excluded.    

In relation to governmental funding source(s), financial interest does not include:

    1. Salary, royalties, or other remuneration from the University or its auxiliary organization; 
    2. Income from honorariums, seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. academic teaching hospitals, medical centers, or research institutes affiliated with institutions of higher education; 
    3. Salary, royalties or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the last 12 months or anticipated in the next 12 months are not expected to exceed the allowed amount from any single business enterprise entity;
    4. Income from investment vehicles, such as mutual or pension funds or other investment over which the Investigator does not exercise investment decisions.
    5. Travel reimbursed or sponsored by U.S. federal, state, or local government agencies, an institution of higher education, an academic teaching hospital, a medical center, or research institute affiliated with a U.S. institution of higher education.

Foreign Support: Regardless of the above minimum requirements for financial interests, investigators must disclose any foreign financial interests as these differ from disclosure of domestic financial interests. Investigators must disclose all foreign financial interests to address any malign foreign influence concerns.

Project-based Interests: Regardless of the above minimum requirements for financial interests, investigators must disclose any other interests, including non-financial, related to institutional responsibilities and external funding that could present an actual or potential conflict of interest. The University recognizes disclosure as a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

Remuneration: Includes salary and payments for services, such as consulting fees, honoraria or paid authorship, and cash or in-kind gifts from entities for which you provide services and, sponsored travel.

5.00 Investigator Disclosure & Resolution Plan

Investigators shall disclose financial interests at the time of proposal submission, upon award, and update this information annually or more frequently as new financial interests are obtained or new investigators are added to a project during the life of the award. Awards cannot be accepted until any conflict of interest issues are resolved.

Each investigator must complete the COI Disclosure Form which may include the Statement of Economic Interest CA Form 700-U for private funding. The form must be submitted concurrently with the submission of the proposal. In addition, each investigator shall make a disclosure at any time during the award period when a material change occurs that presents a conflict of interest as defined by this policy. 

Disclosures will be reviewed by the IO or designee and as applicable shall convene an ad hoc Independent Review Committee (IRC) to determine whether a conflict of interest exists. Upon such a finding, the investigator(s) will be notified of the finding and asked to devise a Management Plan to manage, reduce, or eliminate the potential or actual conflict(s) of interest which will be reviewed for final approval by the IO or designee and as applicable an ad hoc Independent Review Committee (IRC). Upon implementation of the management plan, the IO or designee shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the funded award. 

Management Plans may include but not be limited to the following: 

  1. Public disclosure of financial interests
  2. Monitoring of research by independent reviewers
  3. Modification of the research plan
  4. Disqualification from participation in the portion of the project that is affected by the financial interest
  5. Divestiture of financial interests
  6. Severance of relationships that create actual or potential conflicts.

A Human Resources (HR) designee will serve as the University and its auxiliaries’ contact with external entities for reporting, resolving, and otherwise dealing with matters related to this policy. The HR designee will report disclosure and resolution activities to agencies and funding sources as required and appropriate.

6.00 Enforcement & Sanctions

Investigators with governmental funded awards will have 90 days to complete the COI disclosure form renewal annually. If an Investigator fails to renew their COI Disclosure Form within the allotted time frame funding restrictions may be imposed until the form is received.

Instances of failure to disclose conflict(s) of interest and potential violation(s) of the management plan shall be reported to the IO or designee. Disciplinary measures, if any, shall be in keeping with campus and system-wide policies, procedures, and union contracts current at the time. Funding sources and other appropriate parties shall be notified and kept informed as required by state and federal laws and regulations and sponsored projects award documents.

7.00 Documentation & Record Maintenance

Records of all disclosures and actions taken shall be maintained for a minimum of 3 years after the later of the termination or completion of the award to which such documents relate or the resolution of any action(s) involving these records, whichever is greater. 

The information contained in the COI Disclosure Form may be released or transmitted to the sponsor, including federal agency representatives, and in accordance with state law, it may also be released to the public upon request.

8.00 Training Requirements

Nongovernmental Funding Sources:

Investigators who are awarded grants from non-governmental sponsors, must complete the Chancellor’s Office Conflict of Interest training program within six (6) months of receiving a grant. Subsequent training is required at least once within each two (2) calendar year period that the grant is in place. 

Governmental Funding Sources:

Investigators must complete COI training via CITI Program prior to engaging in funded activities and also complete refresher training every four (4) years thereafter. In addition, updated training may be required upon revisions to the CSUMB COI policy, procedures, or form in any manner that directly affects the requirements of disclosure; when an investigator is new to the University or its auxiliaries; and when the University finds that an investigator is not in compliance with this policy.

9.00 References and Related Policy Information

Where there are substantive differences between this policy and the referenced or related documents below, the following regulations shall take precedence:  

10.00 Continuous Renewal

This policy shall be reviewed ten years from its effective date to determine its utility and appropriateness. This policy may be reviewed before that time as necessary.

s/ President Vanya Quiñones

Effective Date: May 13, 2025

Certification of Process

Reviewed by:  Policy Facilitation Team, Academic Leadership Team, Academic Senate Executive Committee, Committee on Research, Scholarship, and Creative Activity, Sponsored Programs Office, Enrollment Management & Student Affairs, Administration & Finance, and University Advancement

Download a signed .pdf version of this policy