GIM 10 establishes University of Washington (University) policy for the disclosure, review, identification, and management of Financial Conflicts of Interest (FCOI).
The University is committed to promoting research integrity and supporting a balance between academic freedom, confidentiality and security in all research, sponsored program, and technology transfer activities occurring under its auspices. Such activities shall be conducted in full compliance with all University policies and applicable federal and state laws pertaining to conflicts of interest.
The University has an institutional responsibility to establish and maintain policies that promote objectivity in the design, conduct, and reporting of research activities in accordance with best practices, sponsor requirements, and federal and state law. In accordance with Chapter 42.52.220, the policy and administrative procedures described herein, shall apply in place of certain obligations imposed on institutes of higher education, faculty, and university research employees.
Disclosures shall be submitted in accordance with this policy and described procedures, to the Office of Research and will be reviewed by the Institutional Official (IO) or their delegate(s). FCOI that cannot be sufficiently reduced, mitigated, or eliminated may not be permitted and, as such, the proposed University activity may need to be redesigned to reduce, mitigate, or eliminate the FCOI or shall not proceed, as determined by the IO, in collaboration with other persons/offices affected, as required to ensure institutional and individual compliance with applicable state and federal requirements.
SFI are required to be disclosed within thirty (30) days of acquiring new or increased SFI, within thirty (30) days of joining an ongoing activity, at least annually, and as required by the IO.
Disclosures submitted for sponsored programs must be done in accordance with sponsor processes, policies, and award terms and conditions. These disclosures shall be reviewed in accordance with pertinent requirements and shall belong in one of the following two categories:
- Institutional Review (IR): All Significant Financial Interests (SFI) shall be disclosed by the Investigator to the University for its review and determination of potential FCOI.
- Investigator Determined (ID): SFI determined by the Investigator to relate to the University sponsored program under review shall be submitted for consideration and determination by the University of potential FCOI.
SFI reviews for potential FCOI shall be completed in advance of approval of the related University agreement, or performance of the outside activity, and in some cases are required to be completed in advance of expenditure of funds, per sponsor requirements.
Access to Disclosure Details
Individuals and groups that shall have access to all disclosures submitted in accordance with this policy are: the Chair of the Department, or other organizational head; the Dean’s Office of the appropriate College or School; Office of Research staff with responsibilities related to this policy; the Vice Provost for Research and designee(s).
The University may be required by sponsors or other regulations to make publicly available, details of identified and managed FCOI. If required, they shall be posted to a publicly available webpage on a routine basis no later than thirty (30) days following the approval of the management plan. This information shall remain available for at least three (3) years from the date the information was most recently updated.
Sponsored research may, per policy, regulation, or other terms and conditions, additionally require the University to report and receive sponsor approval to proceed with the research activity subject to conditions and/or other strategies to reduce, mitigate, or eliminate the identified FCOI.
- Initial reports and approvals shall be completed in advance of expenditure of any sponsored program funding.
- Annual and subsequent reports shall be submitted in accordance with sponsor requirements, and within sixty (60) days of the FCOI being identified.
- Report details shall include information such as: project number, Principal Investigator, name of Investigator with FCOI, nature and value of the interest, description of relation of FCOI to research and basis for University determination, description of key elements of management, role and duties of conflicted Investigator, conditions of management and how it will safeguard objectivity in the research, monitoring strategies, other information as needed or appropriate.
SFI not disclosed or reviewed in a timely manner and FCOI management plans for which non-compliance may be present shall be subject to Retrospective Reviews for bias as required by the research sponsor or IO. These reviews shall occur within one-hundred twenty (120) days from the date non-compliance was identified with results being reported to pertinent individuals, offices, sponsors, or others as appropriate. In circumstances where bias is identified, mitigation plans shall be developed, implemented, and reported to applicable sponsors or agencies.
University FCOI training shall be required when Investigators are participating in sponsored programs or activities where the sponsor, regulations or other terms and conditions require the completion of training on the University’s FCOI policy and as required by the IO, as appropriate. Sponsor training requirements must be completed in accordance with their respective policies, before participating in the research, and at least every four (4) years.
Sanctions and Remedies
Upon determination by the IO that a violation of this policy has occurred, including any failure to make proper disclosure or comply with a management plan, the IO shall recommend appropriate sanctions consistent with University policies and procedures.
The IO, or their delegate, shall confirm all Investigators participating in research at subrecipient organizations are subject to conflict-of-interest rules and procedures no less stringent than this policy, as required by sponsor, state, or federal requirements.
No one may participate as an Investigator in a clinical trial (CT) sponsored by a start-up, commercial, or non-profit organization in which the Investigator has a related Equity or Intellectual Property interest, holds a management position in the organization, or serves on the organization’s Board of Directors unless 1) the IO has determined, in collaboration with the appropriate School, College, or Unit leadership, there are compelling circumstances and it has been concluded there exists an overriding public interest justifying participation by the conflicted Investigator in the CT; and 2) measures are in place to reduce, mitigate, or otherwise manage potential effects of an FCOI on the CT.
Responsible for identifying and reporting new Investigators and Innovators as they become known within ten (10) days and ensuring their, and all other subordinate or direct reports, compliance with procedures outlined in this policy.
Investigator or Innovator:
Submits complete, accurate and timely disclosures, in accordance with this policy, of their personal financial interests and SFI as appropriate; participates in the design and implementation of conflict management plans; complies with conflict management plans and promotes open disclosure and best practices in research integrity in the performance of their University duties.
Research Administration Personnel:
Assists in coordination of administrative components related to this policy, confirms Investigator and Innovator designations with appropriate persons/offices, provides other disclosure support as appropriate.
Department Chair, or Head of Academic Unit:
Ensures sufficient and appropriate internal controls are in place for the successful implementation of issued FCOI management plans or other related restrictions and conditions, with an emphasis on promoting disclosure and transparency in academic and scholarly activities.
Office of Research:
Take such actions that it deems reasonable to audit and/or monitor compliance with conflict management plans and strategies, which may include obtaining regular reports from individuals or committees charged with oversight responsibilities in connection with conflict management; promulgates this policy with respect to compliance and integrity.
Office of Sponsored Programs:
Verifies fulfillment of requirements of this policy in accordance with procedures and job-aids internally developed in collaboration with the Office of Research Central (ORC).
The Institutional Official (IO):
Is authorized to administer and enforce this policy. Such authorization permits the IO, or their delegates, to (i) obtain and review SFI disclosures under this policy; (ii) develop and implement conflict management strategies and documentation to reduce or eliminate identified FCOIs; (iii) conduct any required late or retrospective reviews, including issuance of reports of findings and conclusions and development and implementation of conflict and mitigation plans; (iv) communicate with federal and other sponsors on matters pertaining to this policy; (v) make recommendations to the University with respect to matters covered by this policy; (vi) develop and implement reasonable and appropriate summary procedures for the disposition of matters involving compliance with this policy, and (vii) disallow for good cause a proposed research project or technology transfer transaction or suspend an ongoing research project or pending technology transfer transaction to prevent any probable or continued violations to this policy, or to prevent any inadvertent violations of sponsor policy, state, or federal law or regulation.
Human Subjects Division:
Liaises with Investigators and Institutional Review Boards (IRBs) as required by conditions or restrictions imposed in conflict management plans or otherwise required by sponsor, state, or federal policy.
Informs innovators identified on relevant intellectual property of their obligation to submit SFI Disclosures if they have an SFI related to the proposed Technology Transfer Transaction
May remind Investigators and Innovators of their responsibilities related to best practices in conflicts of interest, this policy and associated processes, any implemented conflict management plans or strategies, and University, or other related resources as appropriate.
Means remuneration or anything of value provided to the individual, without limitation. This includes, but is not limited to, salary and payment for services, consulting fees, payment of personal travel expenses, board membership, affiliations and appointments, etc. Compensation shall not include salary, royalties, remuneration, or honoraria associated with the performance of University activities when received under a University agreement, contract, or employment.
Means the reporting of SFI, or other personal financial interests, to the University.
Financial Conflict of Interest or FCOI
Means a Significant Financial Interest of a researcher that could directly and significantly affect the design, conduct, or reporting of University research, technology transfer, academics, or scholarship.
Immediate Family Member
Means within their household, a person’s spouse, domestic partner, parent, grandparent, grandchild, sibling, dependent child, or anyone who qualifies as the person’s dependent under the U.S. Internal Revenue Code.
Institute of Higher Education
Means any domestic institute of education meeting the definitions and standards outlined in Chapter 28-Higher Education Resources and Student Assistance Subchapter I-General Provisions.
Means one or more persons designated by the University as having responsibilities and authority under this policy.
Investigator and Innovator
Investigator and Innovator are roles held by University personnel independent of their title or position, and may include students, trainees, faculty, and other University Research Employees (as defined RCW 42.52.010(24)).
- Investigators contribute in a significant or meaningful way to the design, conduct, or reporting of University research and research-related activities with a degree of independence, as ultimately determined by the Principal Investigator.
- Innovators have created in whole or in part any Intellectual Property (Executive Order No. 36) in which the University has any right or interest, as identified in accordance with Administrative Policy Statement 59.4
Conflict Management Plan
Means a written plan instituted by the University for the management, reduction, or elimination of a Financial Conflict of Interest.
Significant Financial Interest or SFI
Means a financial interest related to University activities, or that could affect performance of an individual’s University activities; or that requires disclosure according to state, federal, or sponsor requirements. SFI is present when any of the following are held by the University personnel or their Immediate Family Member and occur at the following thresholds:
- Outside Compensation received or anticipated in a 12-month period, when aggregated exceeding $5,000 in value (including the value of payment or reimbursement for personal travel expenses),
- Any ownership in a privately held for-profit, non-profit, or organization type for which Principal or Director holdings may not readily be valued,
- Ownership in a publicly traded for-profit entity exceeding $5,000 in value,
- Sponsored or reimbursed travel expenses associated with, or related in any way to, the performance of University activities when funds originate from a non-Institute of Higher Education or any Foreign educational organization or government.
- Conflict Management Guidelines, to-be-established-page
- Current and Pending, or Other Support
- Employee Responsibilities and Employee Conflict of Interest
- Foreign Interests in Sponsored Programs
- Outside Professional Work (Outside Professional Work Policy)
- Outside Consulting Activities and Part-time Employment by Professional or Classified Staff Employees
- Personal Use of University Facilities, Computers, and Equipment by University Employees
- Use of Human Subjects
- Patent, Invention, and Copyright Policy
Office of Research (email@example.com), 206-616-0804
Details on changes to this GIM are available from the Office of Sponsored Programs, firstname.lastname@example.org