4300P Investigator Significant Financial Interest Disclosure (Procedures)

Original Date: 3/1/1998 * Last Revision Effective: 7/20/2021 (temporary)
Policy Contact: Vice President, Administrative Services

Purpose

The following procedures are established to meet the requirements for implementing policy #4300 – Investigator Significant Financial Interest Disclosure.

Procedures

Training

Bellevue College principal investigators (PI) or other relevant project personnel submitting projects to external funders much comply with investigator significant financial interest disclosure requirements. As part of developing the proposal, the grant director or designee will inform all investigators involved in the project of the following:

  • the college’s policy on financial interest disclosure,
  • the PI’s disclosure responsibilities,
  • federal regulations on financial disclosures.

In the event that a PI is seeking funding from the National Institute of Health, they must complete financial conflict of interest training under the following circumstances:

  • prior to engaging in research related to the project
  • at least once every four (4) years
  • immediately, if:
    • Bellevue College revises policy 4300 or procedure 4300P in a way that affects the investigator,
    • if the investigator is new to the college, or
    • if the investigator is not in compliance with the policy or conflict of interest management plan.

Disclosure Requirements

When submitting a proposal to an external sponsor, each investigator is require to disclose any significant financial disclosures that may exist. An investigator is defined as the principal investigator of the project, co-principal investigators, or significant project personnel required to successfully enact the project (hereafter collectively referred to as PIs). PIs are required to disclose the following to the vice president of administrative services (VP AS) with the grant application:

  • any significant financial interest of the PI that would reasonably appear to be affected by 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 activities funded, or proposed for funding, by an external sponsor.

To avoid any appearance of a conflict of interest, an investigator may wish to disclose other interests.

In the process of institutional decision-making, any disclosed significant financial interest including confidential documentation, may be referred by the VP AS to the affected deans, department chairs and directors as well as other college administrators, pertinent advisory committees, and legal counsel. Confidential information will not be released by the college to other parties except as required under state laws or federal requirements.

Any significant financial interest must be disclosed at the time a proposal is submitted for review. These financial disclosures must be updated by PIs on an annual basis during the period of the award. If a new significant financial interest arises at any time during the period after submission of the proposal through the entire period of any resulting award, the filing of a new disclosure form is required within 30 days. When a PI is added to a project, or when an existing PI on a project develops a new potential significant financial interest, they must disclose those within 30 days. The VP AS will, within 60 days, review the disclosures, determine whether the disclosure of a significant financial interest is related to the research, determine if it rises to the level of a financial conflict of interest, and if so, develop a management plan with specific actions to manage the financial conflict of interest.

Whenever a PI has a conflict of interest to report, they shall complete a significant financial interest disclosure form and attach all pertinent supporting documentation related to the significant financial interest disclosed. The completed disclosure form must be submitted with the proposal and the BC Contracts Signature Approval Form to the VP AS. The supporting documentation that identifies the entity(ies) involved and the nature and amount of the interest is recognized to be sensitive and should be addressed to the VP AS. When reviewing the proposal, the VP AS will review the sensitive material.

The VP AS or designee will review the disclosure form to determine if the disclosed significant financial interest is related to the proposed project or proposed sponsor, and if so, if the significant financial interest could affect the design, conduct, reporting, research or activity under the proposed sponsored project. The VP AS will use he definitions outlined at the end of these procedures and federal regulations, to determine whether the PI’s significant financial interest is related to the research, and if so, whether that rises to the level of a financial conflict of interest. If the VP AS determines the disclosed significant financial interest rises to the level of financial conflict of interest, they will confer with the relevant administrator(s) regarding the disclosure form and any confidential supporting documentation prior to transmitting the proposal. Through this joint review, the VP AS and the relevant administrator(s) will determine what conditions or restrictions, if any, should be imposed by the college to resolve potential conflicts of interest arising from the disclosed significant financial interest. Together, they will develop a conflict of interest management plan that proposes steps to be taken to manage, reduce, or eliminate any actual or potential conflict of interest presenting by a significant financial interest. The management plan should include provision for:

  • public disclosure of significant financial interests;
  • review of project protocol by independent reviewers; and
  • monitoring of project by independent reviewers.

The PI will review the management plan, and either approve it as submitted or may propose conditions or restrictions that may include the following:

  • modification of the project plan,
  • disqualification from participation in all or a portion of the project funded,
  • divestiture of the significant financial interest, or
  • severance of relationships that create conflicts.

If the VP AS, in consultation with the relevant administrator(s), determines that imposing conditions or restrictions would be ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by the public’s interest in educational progress or technology transfer, then they may allow the project to go forward without imposing conditions or restrictions, provided that this action is consistent with applicable federal rules.

The approved management plan will be incorporated into a memorandum of understanding (MOU) that details the conditions or restrictions to be applied in the conduct of the project, or in the relationship with the entity in which a significant financial interest has been disclosed. The MOU shall be signed by the PI, and the PI’s supervisor and, in cases where the PI is a faculty member, the PI’s dean. Any identified conflict of interest must be eliminated or made subject to a plan for satisfactory management prior to the expenditure of any funds under the award.

Whenever a PI has violated this policy, or the terms of an MOU, the VP AS, in consultation with the relevant administrator(s), will recommend appropriate action. The PI’s supervisor and, in the case of faculty members, the PI’s dean, will enforce any disciplinary action consistent with college rules.

If Bellevue College identifies a significant financial interest that was not timely disclose by a PI or, for whatever reason, was not previously reviewed by the college during an ongoing research project (e.g., was not timely reviewed or reported by a subrecipient), the VP AS shall within sixty (60) days review disclosures of the significant financial interest, determine whether the financial interest is related to the research; determine whether a financial conflict of interest exists; and if so, implement a management plan that specifies the actions that have been, and will be taken to manage such a financial conflict of interest going forward.

Reporting Requirements

Bellevue College will send initial annual, ongoing, and revised financial conflict of interest reports, including all required information defined in federal and agency regulations, to the funding agency about both the college and its subrecipients, if applicable. These reports will be submitted:

  • prior to the expenditure of any project funds,
  • within sixty (60) days of adding a new PI to a project,
  • within sixty (60) days of when a new or newly identified financial conflict of interest for existing PIs arises,
  • at least annually, with any annual reports for projects or for extensions.
    • The annual report will provide the status of the financial conflict of interest and any changes to the management plan if applicable until the project is completed
  • after a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.

Bellevue College will also notify the funding agency promptly if bias related to a significant financial conflict of interest is found with the design, conduct or reporting of sponsored research and include the requirement to submit a mitigation report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation.

Reports to federal agencies will include all required reporting elements, including the college’s name, the PI’s name with the financial conflict of interest, the nature of the significant financial interest, the value of the financial interest, and other pertinent details.

If a PI fails to comply with this policy and associated procedures, or the management plan, or the management plan appears to have biased the design, conduct, or reporting of the sponsored research, the college will notify the sponsoring agency promptly. The college will take corrective action for noncompliance with the college’s policy or the management plan and notify the agency of the actions taken.

Record Maintenance and Disposal

Records of PI financial disclosures and of actions taken to manage conflicts of interest are maintained and disposed of in accordance with applicable federal and state records retention schedules; records are retained for six (6) years after the termination or completion of the award to which they relate, or until the resolution of any outstanding issues involving those records, whichever is longer.

Enforcement Mechanisms and Remedies for Noncompliance

If as PI or other relevant project personnel willfully chooses not to disclose a significant financial interest, a financial conflict of interest, or any party (e.g., the PI, deans, the VP AS) willfully obstructs the review process, then the college reserves the right to leverage enforcement mechanisms and provide for employee sanctions or other administrative actions that may include formal letters of reprimand, restriction on the use of funds, removing the investigator from the project, or other actions deemed appropriate by the supervisor and institution.

When such actions occur, the college will complete a retrospective review within one hundred twenty (120) days of its determination of noncompliance when a significant financial interest is not disclosed timely or previously reviewed or whenever a financial conflict of interest is not identified or managed in a timely manner, including:

  • failure by the PI to disclose a significant financial interest that is determined by the college to constitute a financial conflict of interest,
  • failure by the college to review or manage such a financial conflict of interest,
  • failure by the PI or other relevant project personnel to comply with the financial conflict of interest management plan.

Bellevue College will document the retrospective review, which will include the following elements:

  • project award number,
  • project title,
  • PI name or contact PI, if multiple PI model is used,
  • name of the PI or other project personnel with a financial conflict of interest,
  • name of the entity with which the PI or other project personnel has a financial conflict of interest, reasons for the retrospective review,
  • detailed methodology for the retrospective review (e.g., documents reviewed, reviewing persons),
  • findings of the review,
  • conclusions.

If the sponsored clinical research project, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by a PI with a financial conflict of interest that was not managed or reported by the college as required by the regulation, the college will require the investigator involved to:

  • disclose the financial conflict of interest in each public presentation of the results of the research, and
  • request an addendum to previously published presentation.

Subrecipient Requirements

Subcontractors funded from all federal awards to Bellevue College, including the National Science Foundation and National Institute of Health, must provide appropriate written assurances to the VP AS that they have the equivalent of these policies and procedures in place before Bellevue College approves and transmits its proposal and subcontract. Where applicable, Bellevue College will establish, via a written agreement, whether the subrecipient will follow the financial conflict of interest policy of the awardee institution or their own policy. If using its own policy, the subrecipient must include the following provisions in writing:

  • provide certification that its financial conflict of interest policy complies with federal regulations,
  • report identified financial conflict of interests for its PIs in a time frame that allows Bellevue College to report identified financial conflict of interest to agencies as required by federal regulations,
  • solicit and review subrecipient PI disclosures that enable Bellevue College to identify, manage and report identified financial conflicts to interest to federal agencies.

Public Accessibility

Information concerning PI financial conflicts of interest can be accessed by contacting the individual identified on the BC Grants Office webpage of the Bellevue College website. Information will be made available within five (5) business days of a written request. This information will remain available for six (6) years from the date the information was recently updated.

This is not the only college polity governing conflict of interest and employee may have different or additional obligations under the state ethics law.

 

Definitions

Conflict of interest

  • occurs when there is a divergence between an individual’s private interest and their professional obligations to the college such that an independent observer might reasonably question whether the individual’s professional actions or decisions are distorted by considerations of personal gain.

Principal Investigator (PI)

  • means the principal investigator (PI), co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of research or educational activities funded, or proposed for funding, by an external sponsor. The term also includes the Investigator’s spouse and dependent children.

Significant financial interest

  • means anything of monetary value received or purchased within the past twelve (12) months over $5,000, including, but not limited to:
    • salary or other payments for services (e.g., consulting fees or honoraria)
    • any equity interests (e.g., stocks, stock options or other ownership interests in entities either publicly traded or private),
    • intellectual property rights (e.g., patents, copyrights, and royalties from those rights)
    • reimbursed or sponsored travel.

The term does not include:

    • salary, royalties, or other remuneration from the college;
    • income from seminars, lectures, or teaching engagements sponsored by public or nonprofit teaching entities as defined by 20 U.S.C. 1001(a);
    • income from service on advisory committees or review panels for public or nonprofit entities as defined by 20 U.S.C. 1001(a);
    • travel on behalf of the college;
    • income from mutual funds or retirement accounts where the individual does not have direct control over investment decisions.

Relevant Laws and Other Resources

  • BC Policy #4300 Investigator Significant Financial Interest Disclosure
  • BC Policy #6820 Grants and Contracts
  • BC Procedure #6820P Grants and Contracts
  • BC Policy #1150 Contract and Signature Purchasing Authority
  • BC Procedure #1150P Contract and Signature Purchasing Authority
  • Chapter 42.52 RCW Ethics in Public Service
  • Chapter 42.56 RCW Public Records Act
  • 20 U.S.C. 1001 (a)

Revision History

Original 3/1/1998
Revisions 5/10/2005; 5/21/2009; 9/11/2012; 4/7/2015; 7/20/2021 (temporary)

Approved By

President’s Cabinet

Last Updated August 12, 2021