Financial Disclosure Policy for Federally Funded Projects (Non-PHS Funded)

Public Health Services (PHS)-Funded Projects Financial Conflict of Interest Requirements

Investigators must ensure that their outside obligations, financial interests, and activities do not conflict or interfere with their commitment to the University. The Public Health Service (PHS) has enacted a regulation stating that an investigator cannot have a significant financial interest that might impact his or her objectivity in their research unless they disclose it to the Research Compliance Officer and create a management plan. For example, a researcher cannot own stock in a pharmaceutical company while also getting NIH funding to research the invention of a prescription drug that would increase the value of the company that they own interest in unless they disclose it. That financial conflict of interest could create the possibility that their research objectivity is compromised.

Definitions

Significant Financial Interest (SFI) is anything of monetary value or potential monetary value received from a non-University source that reasonably appears to be related to the individual’s duties and responsibilities including, but not limited to payment from a non-university source, travel, stock, or intellectual property.

  • With regard to any entity whose equity securities are publicly traded, a Significant Financial Interest exists if the aggregate value of one or more of the following exceeds $5,000: (I) any compensation received during the twelve months preceding the date of the SFI disclosure, (ii) any compensation reasonably anticipated to be received in the twelve months following the date of the SFI disclosure, (iii) the value of any equity interest in the entity as of the date of the SFI disclosure;
  • With regard to any entity whose equity securities are not publicly traded, an SFI exists if (I) the value of any compensation received from the entity in the twelve months preceding the date of the SFI disclosure and/or reasonably anticipated to be received in the twelve months following the date of the SFI disclosure when aggregated, exceeds $5,000, or (ii) the investigator or innovator holds any equity interest (e.g., stock, stock option, or other ownership interest);
  • With regard to any entity, significant financial interest exists if the investigator or innovator has received income related to any intellectual property during the twelve months preceding the date of the financial disclosure and/or reasonably anticipated to be received in the twelve months following the date of the SFI disclosure which, when aggregated with other financial interests in the entity, exceeds $5,000; or
  • With regard to any entity, an SFI exists if during the twelve months preceding or following the date of SFI disclosure, the investigator or innovator receives or reasonably anticipates receiving one or more gifts (including but not limited to reimbursed travel or sponsored travel meeting the definition of gift) having an aggregate value of $50 or more from the entity.

Financial Conflict of Interest is a financial interest that could directly and significantly affect the design, conduct, or reporting of funded research, or the performance of duties and responsibilities performed on behalf of Western Washington University.

An investigator is not just defined as the Principal Investigator, it all includes graduate students, undergraduate students, and the spouse or dependent children of any of the above.

Disclosure of Conflicts of Interest

The University requires that faculty or staff investigators disclose any significant financial interest that may present an actual or potential conflict of interest in relationship with externally funded projects.

Financial Conflict of Interest Management Plans

If an Investigator has a financial conflict of interest, the conflict of interest management committee will create a management plan. This will be a written plan to eliminate or manage the financial conflict of interest.

Policy Provision 1:

All PHS sponsored investigators must disclose to the Research Compliance Officer (RCO) significant financial interests that may constitute a financial conflict of interest prior to the submission of a PHS sponsored proposal. PHS-sponsored investigators new to the University must disclose significant financial interests prior to disbursement of federal funds. Subsequent to the initial disclosure, investigators must submit updates annually by January 15. If the Investigator acquires a significant financial interest during the course of the year between annual disclosures, the Investigator must report it to the RCO within 30 calendar days.

Mandatory Financial Conflict of Interest Training

RSP will provide the mandatory financial conflict of interest training to all PHS sponsored investigators.

Western Washington University Policies and Procedures

Reporting Financial Conflict of Interest by Public Health Services Funded Investigators

Reporting Financial Conflict of Interest by Public Health Services-Funded (PHS) Investigators

Reporting Financial Conflict of Interest for PHS Funded Investigators Form

Financial Disclosure Policy for Externally-Funded Projects

 

Financial Disclosure Policy for Federally Funded Projects (Non-PHS Funded)

The University and its faculty often benefit from the faculty's participation in both public and private outside activities. The University has no interest in setting forth detailed rules that may interfere with faculty members' legitimate outside interests.

Faculty members/investigators, in turn, must also ensure that their outside obligations, financial interests, and activities do not conflict or interfere with their commitment to the University. This obligation pertains to both full-time and part-time faculty.

In accordance with Federal regulations, the University has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of a faculty member/investigator. Thus, the University requires that faculty member/investigators disclose any significant financial interest that may present an actual or potential conflict of interest or commitment in relationship with a federally sponsored project.

Faculty members/investigators are required to make full and timely disclosures to the University of all outside financial activities and/or financial holdings related to their federally funded grant and research activities. They must also disclose equities and position of immediate family members which could create a conflict of interest or the perception of same between their University obligations and the family member's outside activities and/or financial holdings.

The areas of potential conflict may be divided into two categories. Conflicts of Interest are defined as situations in which faculty members/investigators may have the opportunity to influence the University's business decisions in ways that could lead to personal gain or give improper advantage to members of their families or associates. Conflicts of Commitment are defined as situations in which faculty members/investigators' external activities interfere or appear to interfere with their paramount obligations to their students, colleagues, and the University.

Guidelines

In those circumstances in which the University is engaged in or intends to engage in a federally funded project with a commercial organization, or has subcontracted or intends to subcontract to an external organization under one of the University sponsored federal projects, a conflict of interest may occur when a faculty member/investigator's affiliation with the federal government or external organization involved in the project meets the following criteria:

  1. The faculty member/investigator is an officer, director, partner, trustee, employee, advisory board member, or agent of an external organization or corporation assisting in the funding of the federally sponsored project or providing goods and services under a sponsored project in which the faculty member/investigator is participating in any capacity.
  2. The faculty member/investigator is the actual or beneficial owner of more than five percent(5%) of the voting stock or controlling interest of such organization or corporation, and;
  3. The faculty member/investigator has dealings with such organization or corporation from which he or she derives income of more than $10,000 per year, exclusive of dividends and interest.
  4. The faculty member/investigator's immediate family meet any of the criteria stated in a-c above.

Each faculty member/investigator participating in a University federally sponsored project must disclose whether or not he or she has external affiliations that may constitute a conflict by falling within the criteria stated in paragraphs a-d above. A disclosure must be completed prior to the University's acceptance of the federally sponsored project or issuance of purchase order or subcontract for the acquisition of goods and services. The disclosure form(attachment 1) is to be sent to the Office of Risk Management through the faculty members/investigator's department chair or dean. Positive disclosures will be reviewed by a Conflict Review Committee consisting of the Vice Provost for Research, the Asst. Att. General, the Director of the Research and Sponsored Programs, and the Director for Risk Management.

In reviewing the positive disclosures, the Conflict Review Committee will be guided by the following practices and apply them as may be appropriate:

  1. Assure adherence to relevant University policies, state laws, and procedures, the Faculty Handbook, and other University documents the Conflict Review Committee may deem appropriate.
  2. Consider the nature and extent of the financial interest in the relationship of the faculty member and the external organization.
  3. Give special consideration to the terms and conditions of sponsored project agreements that may mitigate or complicate the given situation.
  4. Consult with and obtain additional information from the faculty member as either the Conflict Review Committee or the faculty member/investigator feel may be helpful in resolving actual or potential conflicts.
  5. Act in a timely manner so as not to delay unduly the conduct of the federally sponsored project.
  6. Conclude that the University may take one of the following actions:
    1. Accept the sponsored project award.
    2. Not accept the federally sponsored project award.
    3. Accept the sponsored project subject to suitable modifications in either the sponsored project award document or the external organizational affiliation of the faculty member or faculty member's family.

If the faculty member/investigator is dissatisfied with the Conflict Review Committee's conclusion, the faculty member may appeal to the Provost who will consult with the faculty member/investigator and the Conflict Review Committee as the Provost deems necessary and appropriate for the particular circumstance. The decision of the Provost shall be final.

Violations of this policy, such as willful concealment of financial interests, may result in sanctions being imposed upon the violating individual. The Conflict Review Committee will review allegations of violations and will make recommendations regarding the imposition of sanctions to the Provost. The decision of the Provost with regard to the imposition of sanctions shall be final.

Records pertaining to each disclosure will be maintained in strict confidence by the Research and Sponsored Programs. Access to such records will be limited to the faculty member/investigator, the Conflict Review Committee, the Provost, and others who have legal right to review the records.

It shall be the responsibility of the designee of the Conflict Review Committee to inform the federal agency funding the project that the institution is unable to satisfactorily manage a conflict of interest.

Definitions -- Financial Disclosure Policy

  1. Acceptance of royalties for published works and patents, or of honoraria for commissioned papers and lectures.
  2. Service as a consultant to outside organizations provided that the time commitment does not exceed the University policy, and that the arrangement in no way alters the faculty member's commitments incurred in the University's execution of a sponsored agreement on the faculty member's behalf.
  3. Service on boards and committees of organizations, public or private, that does not distract unduly from the faculty members/Investigator's obligations to the University or that does not interfere or appear to interfere with a faculty member's ability to conduct work under sponsored agreements objectively.
Conflict of Commitment:
a potential or actual conflict of commitment exists when commitments and obligations to consulting, research, and other scholarly activities require the individual to perform work or activities during time that the individual is expected to perform services for the University.
Conflict of Interest:
exists if the reviewer(s) of disclosures determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting federally funded activities. Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate conflicts of interest include, but are not limited to:
  1. Public disclosure of significant financial interests;
  2. Monitoring of research by independent reviewers;
  3. Modification of the research plan;
  4. Disqualification from participation in the portion of the federally funded research that would be affected by the significant financial interests;
  5. Divestiture of significant financial interests; or
  6. Severance of relationships that create conflicts.
Investigator:
principal investigator or any other person who is responsible for the design, conduct, or reporting of a research project funded by the federal government or proposed for such funding.
Members of Immediate Family:
the investigator's or faculty members spouse, dependent children, parents, parents-in-law, siblings or other relatives living at the same address as the investigator or faculty member.
Records:
all financial disclosures and all written documentation on action taken by the Institution to manage conflicts of interest shall be retained until three(3) years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.
Reviewer:
a person or persons designated by the institution to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such conflict of interest.
Significant Financial Interest:
anything of monetary value, including but not limited to: salary or other payments for services(e.g., consulting fees or honoraria); equity interests(e.g., stock options or other ownership interests); and intellectual property rights(e.g., patents, copyrights and royalties from such rights). The term does not include:
  1. salary, royalties, or other remuneration from Western Washington University;
  2. income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
  3. income from service on advisory committees or review panels for public or nonprofit entities;
  4. an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, 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 five(5) percent ownership interest in any single entity; or salary, royalties, or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months are not expected to exceed $10,000.

Examples for Use in Identifying Potential Conflicts of Interest and Commitment

The following list of examples serves as a set of guidelines for identifying potential conflicts of interest and commitment. It is not intended as a comprehensive list of all potential situations that could present faculty members or investigators and the University with difficulty.

Activities that are Clearly Permissible

Activities that Present the Potential for Conflict

  1. Relationships that might enable a faculty member/investigator to influence the University's dealings with an outside organization in ways leading to personal gain or improper advantage for the faculty member, or his or her associates, or family members. For example, a faculty member/investigator or family member could have a financial interest in an organization with which the University does business and could be in a position to influence relevant business decisions. Ordinarily, making full disclosure of such relationships and making appropriate arrangements to mitigate potential conflicts would resolve such problems.
  2. Situations in which the time or creative energy a faculty member/investigator may devote to external activities appear substantial enough so as to compromise the amount or quality of his or her participation in the instructional, scholarly, or administrative work of the University.
  3. Situations in which a faculty member/investigator directs students into a research area from which the faculty member/investigator may realize a financial gain. In such situations, the ability of a faculty member to render objective, independent judgment about the students' scholarly best interests may be diminished.

Activities that are Very Likely to Present Unacceptable Conflicts

  1. Situations in which a faculty member/investigator assumes executive responsibilities for an outside organization that might seriously divert his or her attention from University duties. Faculty member/investigator should consult with the appropriate dean before accepting any outside management position.
  2. Use of personal profit of unpublished information emanating from sponsored agreements or confidential University sources, or assisting any outside organization by giving it exclusive access to such information; or consulting with outside organizations that impose obligations upon the faculty member/investigator or the University's Intellectual Property Policy or with the University's obligations under sponsored projects.
  3. Circumstances in which a substantial body of research that could and ordinarily would be carried on within the University is conducted elsewhere to the detriment of the university and its legitimate interests.
  4. Any activity that a faculty member/investigator may wish to undertake on an individual basis that (a) involves or appears to involve the University significantly through the use of its resources, facilities, or the participation of academic colleagues, students, and staff, (b) involves the use of the University's name or implied endorsement, or (c) violates any of the principles set forth in the University Research and Projects Policy (for example, giving the outside organization the right to censor or prohibit publication rights for research any part of which is performed under University auspices).

Disclosure Form