Updated: October 19, 2017
Introduction
Federal regulations require the disclosure of Significant Financial Interests (SFI) from all Investigators upon submission of a proposal for funding to any Public Health Service (PHS) entity, including the National Institutes of Health (NIH) and prior to its expenditure of any funds under an award from the National Science Foundation. Gustavus Adolphus College (the College) is responsible for determining whether any SFI represents a Financial Conflict of Interest (FCOI) and managing such conflicts. The College therefore requires that Investigators disclose any SFI that reasonably appear to be related to their institutional responsibilities when applying for grant funds, as well as during the award period.
Definitions
Investigator means the principal investigator, co-principal investigators/co-project directors, and any other person at Gustavus who is responsible for the design, conduct or reporting of research or educational activities funded or proposed for funding. In this context the term “Investigator” includes the Investigator’s spouse and dependent children.
A significant financial interest consists of financial interests that reasonably appear to be related to the investigator’s institutional responsibilities:
- with regard to any publicly traded entity, a SFI exists if the remuneration received in the 12 months preceding the disclosure, and the value of any equity interest as of the date of disclosure, exceeds $5,000. “Remuneration” includes (i) salary, and any payments for services such as consulting fees or honoraria, paid authorship, reimbursed or sponsored travel and (ii) equity interest includes any stock, stock option, or other ownership interest.
- with regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received in the 12 months preceding the disclosure, and the value of any equity interest as of the date of disclosure, exceeds $5,000, or when the investigator holds anyequity interest.
- intellectual property rights and interests such as patents or copyrights, upon receipt of income related to such rights and interests.
An investigator also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in the federal regulation.
Significant financial interest does not include:
- salary, royalties, or other remuneration paid by the institution to the investigator if the investigator is currently employed or appointed by the Institution;
- intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
- income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a governmental agency, an Institution of higher education, or a research institute affiliated with a higher education Institution.
Collaborators at other institutions must either comply with Gustavus policies or certify to the College that 1) they have reviewed their portion of the project according to their institutional policies and 2) such policies are in compliance with applicable regulations. Whenever a Gustavus project involves consultants or subcontractors, those parties must comply with the College’s Financial Conflict of Interest Policy, where appropriate.
A Financial Conflict of Interest exists if SFI could directly and significantly affect the design, conduct, or reporting on federally-funded research.
Policy
Disclosure of Significant Financial Interests
Each Investigator who is planning to participate in a federally project must complete the Disclosure of Significant Financial Interests form and attach required supporting documentation. This form must be completed and submitted to the Office Research and Sponsored Programs by the time a proposal is submitted. Investigators are required to update their financial disclosures within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) any new Significant Financial Interest; and, if awarded, annually by the anniversary date of the original disclosure.
Review of Financial Disclosures and Management of Financial Conflicts of Interest
The Vice President for Finance and Treasurer will review all financial disclosures reported by each Investigator to determine whether a conflict of interest exists, and report these findings to the Provost in a written report. The Provost is the College-designated official who has primary responsibility for the oversight of the management of conflicts of interest. If a determination has been made that a conflict of interest exists, the Provost will determine what actions should be taken by the College to manage, reduce or eliminate such conflict of interest.
Conditions or restrictions that might be imposed by the College to manage, reduce or eliminate actual or potential conflicts of interest include:
- Public disclosure of Significant Financial Interests;
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification from participation in the portion of the funded research that would be affected by the Significant Financial Interests;
- Divestiture of Significant Financial Interests; or
- Severance of the relationships that create actual or potential conflicts.
To address complex situations, oversight committees may be established by the Provost to periodically review the ongoing activity, to monitor the conduct of the activity, to ensure open and timely dissemination of the research results, and otherwise oversee compliance with the management plan.
Reporting
The College will follow reporting guidelines set forth in the regulations of the federal funding agency. For example, all FCOI will be reported to the PHS sponsoring agency within 60 days of the original disclosure. The College will make information concerning FCOIs held by Investigators publically accessible as required by federal regulations.
Non-Compliance
If the College determines that an Investigator has failed to comply with this policy or any relevant management plans the College will impose sanctions.
Records
The Office of Research and Sponsored Programs shall maintain records of all financial disclosures and of all actions to resolve conflicts of interest for at least three years beyond the close of the grant, or until the resolution of any action involving those records, whichever is longer.
Training
Investigators funded by PHS entities must complete training on this policy prior to engaging in research and at least every four years thereafter. In the event this policy is amended investigators may be required to complete a new training.