Policy Number: EC.01.01.191203
Applies to: All paid and volunteer faculty and administrators at all locations at which they work in any capacity, to promote integrity, confidence, and objectivity in decision-making processes.
Date: 08/1/2023
1.0 Policy Statement
Washington State University’s Elson S. Floyd College of Medicine (WSU College of Medicine) seeks to maintain that faculty members, administrators, and any other individuals who participate in or with decision-making authority affecting the medical education and academic programs and students identify all potential conflicts of interest to avoid the impact of any actual, potential, or apparent conflicts of interest in the operation of the medical education program. Both the actual or possible conflict of interest must be disclosed and the potential benefit and potential risks.
- In addition to required disclosures someone involved in research may also be subject to the WSU Research Conflicts of Interest Research policy. Research activities should be conducted in a manner that addresses conflicts of interest and should comply with relevant provisions of Washington State University’s conflicts of interest on research Policy and applicable laws. For purposes of this policy management of research conflicts of interest disclosure are in the purview of the Office of Research Support and Operations.(See EP #27 WSU).
2.0 Definitions
Affiliations and Commitments
Exist when an individual has a position of authority and control regarding the activities of an entity but does not include typical professional leadership activities such as being a member of a professional association.
Significant Affiliations and Commitments include:
- Ownership or investment in an outside business.
- Serving as a director, officer, partner, consultant.
- Outside professional or other activity.
Conflict of Interest (COI)
Means a significant interest held by an individual and/or immediate family member which could affect teaching, scholarship, or administrative activities, and any situation in which an interest has the potential to unduly influence or appear to influence clinical education, service, or educational activity. Conflicts of interest may be financial (involving the potential for financial gain), general (involving personal gain or privileges) or commitment (involving obligations, responsibilities, or commitments), or otherwise that could interfere with a faculty member/administrators’ responsibilities. A faculty member or administrator may have a conflict of interest that involves faculty members/administrators, spouses, domestic partners or similar relationships, dependent children, and other family members residing in the same household.
Disclosure of Significant Financial Interest
Means disclosure of significant interests to WSU College of Medicine as defined below.
Equity Interest
Means stocks, stock options, ownership, partnership or limited liability company, or other ownership interests. Equity interest does not include interest in a mutual fund or other stock management vehicle not under the individual’s control. But it does include interest held in a deferred compensation plan that is under the individual’s control.
Family
Means spouse, domestic partner, dependent children, and other dependent relatives living in the household.
Financial Interest
Means anything of monetary value, whether or not the value is readily ascertainable.
Significant Financial Interest (SFI)
Means a Financial Interest of the individual and/or the individual’s immediate family which reasonably appears to be related to the amount and type which must be disclosed to WSU College of Medicine, or which creates a Conflict of Interest. The College of Medicine and federal agencies have specific provisions establishing what constitutes SFI. Any of the following is considered a significant financial interest:
- Equity interest (e.g., stock, stock options) exceeding 5,000 dollars.
- Income or compensation for services exceeding 5000 dollars (e.g., fees, loans, gifts, cash, or in- kind compensation); excluding clinical work.
- Intellectual property rights and interests (e.g., patents, copyrights).
- Any sponsored travel.
- Gifts received if the aggregate value of the gifts exceeds 50 dollars value.
Gifts
Means anything received of economic value without giving adequate consideration, including any item, product, or service, regardless of the nature, purpose, or value. A gift of greater than 50 dollars from an outside entity is a significant financial interest and must be disclosed. Note: Gifts greater than $50 may be prohibited under Washington State law. See RCW 42.52. Examples of gifts include, but are not limited to: cash, cash equivalent (e.g., gift cards, stock, subsidies, property, use of property or equipment), promotional items (including office products with the vendor’s logo), goods, donations, favors, prizes, offers of employment or business relationships, or anything reasonably regarded as providing a financial gain or advantage to either the recipient or his/her immediate family member. No faculty member, administrator or individuals may receive, accept, take, seek, or solicit, directly or indirectly, anything of economic value as a gift or favor from a person if it could be:
- reasonably expected that the gift or favor would influence the vote, action, or judgment of the officer or employee, or
- be considered part of a reward for action or inaction.
If neither of these circumstances exist, faculty and administrators including those who participate in or with decision-making authority affecting the medical education and academic programs and students may accept gifts up to $50 in value per calendar year.
Noncompliance
Is defined as the failure to disclose or comply with the management plan of College of Medicine Conflict of Interest Policy and federal regulations. Noncompliance may span from inconsequential to serious, it may be accidental or intentional, and it may occur more than once.
Serious noncompliance
Is conduct that:
- Adversely affects an individual’s WSU College of Medicine activities.
- Results from deliberate misconduct of the individual.
- Harms or poses a significant risk to other faculty, patients, and students.
3.0 Responsible Office
Office of Compliance
4.0 Procedures
Dissemination
The College of Medicine Office of Compliance disseminates this policy to all College of Medicine faculty and administrators through established channels of communication.
Training and Education
The College of Medicine Office of Compliance is responsible for the training program content on conflicts of interest which is facilitated through a conflict-of-interest Online application. Delivery of this program will be coordinated with the requisite administrative offices. Required training program will be incorporated into the onboarding process and during program rollout. Policies are published on the College of Medicine website for public access.
College of Medicine Conflict of Interest Committee (COIC)
The College of Medicine COIC
- The COIC reviews all pertinent documentation, disclosures of significant financial interests, including management plans relating to a potential or actual conflict of interest cases based on federal and state law and policy. The COIC will (1) assess whether a COI exists, (2) assess the extent of the COI, and (3) manage, reduce or eliminate the COI and recommend to the Office of Compliance what conditions and restrictions, if any, are to be imposed by the College of Medicine to manage the potential or actual Conflict of Interest. COIC is charged with being objective and independent.
- The Dean, except to the extent he/she has a Conflict of Interest, will decide all appeals as stated below. The COIC composed of a minimum of two faculty and one administrator who are appointed by the Dean to serve 3-year terms. One member of the COIC is to be nominated by the Faculty Council Executive Committee. The COIC Chair is appointed by the Dean upon recommendation of members of the COIC. Decisions are approved with a quorum of more than 75% of the voting members.
Reporting Responsibilities
All Conflicts of Interest outlined in this policy are managed by the Office of Compliance in consultation with the COIC.
- It is the responsibility of faculty members and administrators to promptly self-report any COI. If COI is identified by another person, it must be first brought to the Office of Compliance. The Office of Compliance will then bring the potential or actual Conflict of Interest to the attention of the faculty member/administrator. If the faculty member/administrator disputes the individual’s assertion, the concern will be then sent to the COIC for resolution.
- The report must include sufficient information to enable the Office of Compliance and COIC to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. The report is to include at a minimum:
- The name of the person reporting.
- Name of the entity with the financial conflict of interest.
- Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium).
- Value of the financial interest in dollar ranges.
- The COIC will determine if the potential or actual conflict exists and if the faculty member/administrator needs to disclose the potential or actual Conflict of Interest.
- The Office of Compliance keeps all completed disclosure forms in a secure document management system. An individual can request access to their own disclosure forms through the Office of Compliance. Faculty and administrators have the responsibility to complete the College of Medicine Disclosure Report upon any of the following:
- Annually.
- Within 30 days of any action that could make a current disclosure obsolete or inaccurate including new positions or appointments, new affiliations, and commitments, or financial situations.
Disclosures
Any individuals seeking to request access to public records of the College of Medicine, including Conflict of Interest disclosures, should contact Washington State University’s Public Record Office located in Pullman. Where required by law, professional ethical canons, and/or WSU Policy, faculty are responsible for disclosing their Conflict of Interest to their students and patients.
Disclosures in Presentations
It is the College of Medicine policy that all presentations/presenters deliver unbiased content in courses/presentations and disclose any potential or actual Conflict of Interest. If a presenter is using slides or other audiovisual media, they will be provided with the presentation materials that contain information clearly stating either a lack of a Conflict of Interest or a disclosure of potential or actual Conflict of Interest.
Resolution and Management of Potential Conflicts of Interest
The College of Medicine requires that Conflict of Interest should be managed, reduced, or eliminated by the divestiture of financial or commitment interest, a modification, or public disclosure and monitoring depending on the situation and the individual’s role at College of Medicine. Disclosure is sufficient for treatment recommendations to patients, as well as educational and promotional presentations.
Administrative Recusal
The COIC and the Office of Compliance receiving a report of a conflict are to be a neutral party. If he/she/they have a significant interest, one should recuse themselves from the discussion about the management, reduction or elimination of the reported potential or actual Conflict of Interest.
Advisory or Consultant Boards
Pursuant to the College of Medicine’s Conflict of Interest Policy, those serving on speaker’s bureaus and/or advisory or consultant boards must:
- Identify the conflict to other board members.
- Identify the conflict to audience members.
- Independently review actions that create a conflict of interest.
Determination/Resolution
The Office of Compliance submits the written conflict of interest management plan to the COIC.
- They approve a management plan that is effective in protecting College of Medicine from any perceived or actual conflict of interest.
- The Chair of the COIC communicates, in writing, the determination(s) of the COIC to the affected individual. The review is to be completed within 30 days of a determination of noncompliance. If a conflict of interest has previously existed, the Office of Compliance requests a retrospective review.
- The retrospective review consists of a review of the affected individual’s activities to determine whether any portion of the individual’s College of Medicine activities was affected. The retrospective review is to be completed within 30 days of a determination of noncompliance.
- All final approved conflict of interest management plans must be complied with at all times. Failure to comply with a conflict of interest management plan may subject the faculty member/administrator to appropriate corrective action in accordance with College of Medicine and/or WSU policy.
- Management plan is monitored for compliance and may include:
- Public disclosure of the financial COI directly to individuals or group identified by COIC.
- Recusal of person’s responsibilities from participation in all or portion of work.
- Reduction or elimination of financial interest (e.g., sale of an equity interest) and /or
- Severance of relationships that create COI.
- If at any time it becomes apparent that the conflict cannot be managed to eliminate any violation of law or policy, the employee must refrain from participating in the activity that creates the conflict.
Appeals
If a faculty member/administrator disagrees with a determination regarding a conflict of interest, she/he/they may appeal the outcome to the Dean. All appeals are to be made in writing within 15 calendar days of the date of the determination. Appeal determination is to be completed within 30 days. Documentation of appeal outcome is to be provided to faculty members/administrators and cognizant chair or vice dean and retained in the Office of Compliance’s secure data management system.
Research
Conflicts of Interest Arising from Significant Financial Interests of Individuals
Monitoring and management of conflict of interest in research are performed by the Office of Research at College of Medicine and Washington State University’s Conflict of Interest Support Team. Management of conflict-of-interest disclosure of research is in the purview of the Office of Research Support and Operations.
Review of Industry-Sponsored Clinical Research
Refer to ORSO Guideline 9 titled, A Guide to Working with Industry Research Agreements with Washington State University. College of Medicine and Washington State University’s Institutional Review Boards (IRBs) are tasked with reviewing all human subject research, including sponsored research. The Office of Research at College of Medicine ensures that industry-funded studies are consistent and compliant with the mission and ethics of College of Medicine.
5.0 Related Policies
- Admissions Conflict of Interest, AD.10.04.170425, WSU College of Medicine
- SEPAC Conflict of Interest, SE.09.04.170808, WSU College of Medicine
- EP #27 WSU
- EP #45 WSU
- RCW 42.52.140
6.0 Key Search Words
Conflict of Interest, Reporting, Disclosure, Compliance.
7.0 Revision History
Original Approval: 12/03/19
Policy Number: EC.01.01.191203
Review/Revision: 12/03/2019, 08/01/2023