5600 - Financial Disclosure Policy
Owner:
- Position: Office of Research Assurances Director
- Email: ored-ora@uidaho.edu
Last updated: July 01, 2023
A. Purpose
B. Scope
C. Definitions
D. Disclosures, Updates, and Changes
E. Review and Management of Research Conflicts of Interest
F. Reporting and Record Retention
G. Training
H. Enforcement and Sanctions
A. PURPOSE
The purpose of this policy is to ensure that no Research Conflicts of Interest directly and significantly impact the design, conduct, or reporting of research or sponsored project activities at the University of Idaho.
The University of Idaho strives to promote objectivity in Research by ensuring that Research at the University of Idaho is free from bias due to an investigator’s financial interests. This policy states the requirements and procedures for disclosing Significant Financial Interests and how a Research Conflict of Interest is determined and managed. Note that for purposes of this policy, a “Research Conflict of Interest” is a “Financial Conflict of Interest” as defined by the U.S. Department of Health and Human Service Public Health Service (PHS) and the Department of Energy (DOE), and a “Conflict of Interest” as defined by the National Science Foundation (NSF) (see C-7).
B. SCOPE. This policy applies to Investigators on Research Projects funded by a Funding Entity as defined in C-4.
C. DEFINITIONS
C-1. “Equity” means any interest in the profits of or other ownership interest in any commercial or non-profit enterprise, including common stock and other securities, and any right to acquire any of the foregoing such as an option, warrant, or other security that is convertible into an equity security.
C-2. “Family” or “Family Member” means the Investigator’s spouse and dependent children.
C-3. “Funding Entity” means > a federal agency or other sponsor that requires an Investigator to disclose their Significant Financial Interests.
C-4. “ Intellectual Property” means the rights from a patent, trademark, copyright, trade secret, or other similar intangible property right, including but not limited to, inventorship or authorship.
C-5. “Investigator” means any person at UI who is responsible for the design, conduct, or reporting of funded Research.
C-6. “Research” means a creative endeavor or a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research (e.g., a published article, book, or book chapter), product development (e.g., a diagnostic test or drug), and any activity for which research funding is available through a grant or cooperative agreement, research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
C-7. “ Research Conflict of Interest” or “RCOI” means a Significant Financial Interest or a financial relationship (for DOE funded projects) of an Investigator or the Investigator’s Family that could directly and significantly affect the design, conduct, or reporting of Research.
C-8. “ Research Conflict of Interest Officer” or “RCOI Officer” means the person appointed by the Vice President of Research to review all disclosures of Significant Financial Interests and to identify and resolve and Research Conflicts of Interest.
C-9. “Significant Financial Interest” or “SFI” means any of the following Financial Interests (1) that reasonably appear to be related to the Investigator’s institutional responsibilities and (2) held by an Investigator or Family Member:
- Remuneration (such as salary, consulting fees, honoraria, paid authorship, payments for services, etc.) received from a foreign or domestic entity other than the UI in the last 12 months and valued at $5,000 or more;
- Equity or other ownership interest in a foreign or domestic entity that is valued at $5,000 or more;
- Equity in a non-publicly traded foreign or domestic entity; or
- Income from the previous 12 months or projected income for the next 12 months that is related to Intellectual Property rights and interests and is $5,000 or more.
- Remuneration (such as salary, lab space, and other tangible benefit) from participation in a Foreign -Government-sponsored Talent Recruitment Program (FGTRP) or intangible benefit from participation in an FGTRP. An FGTRP is an effort organized, managed, or funded by a foreign government, or a foreign government instrumentality or entity, to recruit science and technology professionals or students (regardless of citizenship or national origin, or whether having a full-time or part-time position).
A Significant Financial Interest does not include:
- Remuneration received from seminars, lectures, or services on advisory committees or review panel, or teaching engagements sponsored by public or nonprofit entities;
- Remuneration from mutual funds and retirement accounts if the Investigator or Investigator’s Family Member does not directly control the investment decisions made for the fund or account.
C-10. “SFI Disclosure” means the electronic form used by the University for Investigators to disclose the Significant Financial Interests of themselves and their Family.
C-11. “Sponsored Travel” means travel related to an Investigator’s university responsibilities and paid on behalf of the Investigator rather than reimbursed so that the exact monetary value of the travel is not readily available.
D. DISCLOSURES, UPDATES, AND CHANGES
D-1. Disclosures at the time of the proposal. All Investigators on proposals that require disclosure of SFIs must disclose their SFIs before submitting the proposal for funding. If the Investigator has an SFI Disclosure on file that is less than one year old and reflects all current SFIs for the Investigator and Family Members, a new SFI Disclosure is not required. SFI Disclosures will not be reviewed until the Funding Entity selects the proposal for funding.
D-2. Disclosures when funding is received. If an Investigator’s proposal for Research is selected for funding by the Funding Entity the Investigator shall submit an updated SFI Disclosure to reflect any additional Significant Financial Interests the Investigator or Investigator’s Family acquired after the proposal was submitted.
D-3. Annual disclosures and changes. It is the Investigator’s responsibility to update the SFI Disclosure within 30 days of the Investigator or Investigator’s Family acquiring a new or increased SFI. Investigators shall keep their SFI Disclosure current and submit an updated SFI Disclosure every 12 months. Investigators shall receive notifications from the University’s electronic system when they need to submit an updated disclosure.
D-4. New Investigator added after work begins on a project. If a new Investigator is added to a Research project after work begins, the new Investigator must submit an SFI disclosure before doing any work on the project. The RCOI Officer has 60 days to review the new Investigator’s SFI disclosure and implement a management plan.
D-5. Disclosure after work begins on a project. Investigators are required to renew or re-certify their SFI disclosure every 12 months during the life any Research projects that require SFI Disclosures. The RCOI Officer has 60 days from disclosure of the SFI to review the SFI, determine if an FCOI exists, and implement a management plan. If an FCOI is found, the RCOI Officer shall also review all applicable Research projects the Investigator is working on to determine if the FCOI biased the design, conduct, or reporting of any Research project. If an FCOI is found to have biased a Research project, the RCOI Officer shall take steps to mitigate the bias and shall notify the Funding Entity (if required) and take action as required by the Funding Entity.
D-6. Sponsored Travel disclosures. Investigators must disclose any Sponsored Travel that was paid for on their behalf in the 12 months preceding the disclosure date, was related to their institutional responsibilities, and was paid for by a foreign or domestic entity (but not a state or federal government entity, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institution affiliated with an institution of higher education). If the travel meets the foregoing criteria, the Investigator shall disclose the following information about the travel:
- the purpose of the trip,
- identity of the sponsor/organizer,
- the destination, and
- the duration of the travel.
D-7. Confidentiality. SFI Disclosures shall be kept confidential to the extent allowed by Idaho law, except as required for the performance of University duties..
E. REVIEW AND MANAGEMENT OF RESEARCH CONFLICTS OF INTEREST
E-1. Review and management
- The RCOI Officer shall review all SFI Disclosures to determine if a Research Conflict of Interest exists. A Research Conflict of Interests exists when the RCOI Officer reasonably determines that a SFI could directly and significantly affect the design, conduct, or reporting of the Research. The RCOI Officer may seek input and guidance from other institutional individuals and units when reviewing an SFI Disclosure.
- No funds may be encumbered nor work started on a Research project until the SFI Disclosure review is completed and, if required, a management plan put into place.
E-2. Management plan for a Research Conflict of Interest
- If the RCOI Officer determines that an SFI is a Research Conflict of Interest, the RCOI Officer will draft a management plan to manage, reduce, or eliminate the Research Conflict of Interest. A management plan could consist of (but is not limited to) any of the following:
- Disclosing the Research Conflict of Interest to the appropriate audience or research participants.
- Monitoring or oversight of the Research for bias by an independent 3rd party.
- Modification of the Research plan.
- Change of personnel, their duties, or disqualification of personnel from participating in the Research.
- Total or partial sale of the SFI that created the RCOI.
- Modification or severance of the relationship that created the RCOI.
- The RCOI Officer shall submit the management plan to the University’s Vice President for Research and Economic Development for approval. Work on the project may begin and costs start to accrue after the management plan has been approved by the VPR.
F. REPORTING AND RECORD RETENTION
F-1. Reporting. As required by the funding agency, the University will submit information regarding the FCOI to the funding agency.
F-2. Record Retention. Records created and maintained under this Section 5600 shall be kept for at least three years from the date on which the final expenditure report is submitted to the funding agency or as required by the funding agency.
G. TRAINING. Investigators shall complete RCOI training before incurring or obligating costs on a project if the Funding Entity requires RCOI training. The training shall be repeated every four years for the life of the project or as required by the Funding Entity and immediately when any of the following occur:
G-1. The University revises the policies or procedures of the policy (FSH 5600) in a way that affects the Investigator’s obligations;
G-2. When an individual is identified as an Investigator;
G-3. An Investigator is not in compliance with the University’s RCOI policy or management plan; or
G-4. When requested by the RCOI Officer, a supervisor, or other University official.
H. ENFORCEMENT AND SANCTIONS
H-1. Investigators will receive automated reminders to submit their disclosures. Violations of this policy may be grounds for discipline or sanctions against an employee. The RCOI program office may notify investigators who are more than 30 days delinquent on submitting their disclosure or completing training that they need to complete their disclosure or training. The RCOI Officer may suspend relevant activities or impose other sanctions to help resolve Research Conflicts of Interest or noncompliance with this policy and program obligations.
H-2. The provisions of H-1 apply not only to noncompliance with this policy but also to noncompliance by an Investigator with any requirement relating to conflicts of interest to which UI is subject under state or federal law.
Version History
Amended 2023. Rewritten to address gaps and redundancies and improve readability.
Amended 2022. Editorial changes.
Amended 2007. Editorial changes.
Adopted 1996.