Financial Conflict of Interest
ONU FINANCIAL CONFLICT OF INTEREST POLICY (FCOI)
(Appendix 24 in Faculty Handbook - update 7/20/2012)
1. Each Investigator* (including the investigator’s spouse and dependent children) is to disclose to the vice president for academic affairs all significant financial interests (SFI)** that would reasonably appear to be affected by research, educational or service activities (institutional responsibilities) funded or proposed for funding by the Public Health Service (PHS), the National Science Foundation (NSF) or other external sponsors whose financial interests would reasonably appear to be affected by such activities.
2. FCOI information shall be supplied to the vice president of academic affairs prior to submission of a proposal for funding. Completion of the ONU internal approval form found here provides the necessary information regarding an FCOI prior to proposal submission.
3. Financial disclosures are to be updated during the period of any award on an annual basis, or within 30 days of discovering or acquiring a new reportable significant financial interest. The annual FCOI form is also located at the website above listed as Annual FCOI Update.
4. The vice president for academic affairs will review the financial disclosures of the Investigator related to the Investigator’s institutional responsibilities to determine if a conflict of interest exists and determine further what conditions or restrictions should be imposed to manage, reduce, or eliminate the conflict of interest. Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate conflicts of interest include, but are not limited to:
A. public disclosure of significant financial interests;
B. monitoring of research by independent reviewers;
C. modification of the research plan;
D. disqualification from participation in the portion of the funded project that would be affected by significant financial interests;
E. divestiture of significant financial interests; or
F. severance of relationships that create conflicts.
If the vice president of academic affairs/reviewers determine that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the vice president for academic affairs/reviewers may allow the research to go forward without imposing conditions or restrictions. Should a management plan be required, the Investigator will be required to sign an agreement confirming the details of the plan.
5. At the time of institutional sign-off authorizing the submission of grants, disclosure information will be provided the vice president for academic affairs. The vice president will not approve submission of grants without completion of this form.
6. Failure to comply with this policy will be treated under ONU Faculty Handbook section 2.10, Discipline of Faculty Members.
7. The Office of the Vice President for Academic Affairs will maintain records of all financial disclosures and all actions taken to resolve conflicts of interest for at least three years beyond the date when the final expenditure report is submitted to the organization to which they relate or until the resolution of any Public Health Service (NIH) or NSF action involving these records, whichever is longer.
8. Faculty will receive an e-mail at the beginning of each academic year regarding the University’s policy, their disclosure responsibilities and the federal regulations. This will also be discussed annually during Opening Activities for faculty at the start of each academic year. They will be directed to the appropriate Appendix in the Faculty Handbook and also be provided a link to the University’s FCOI website where the policy will be posted.
9. Each Investigator will be required to complete FCOI training via modules in the CITI program (found here) as follows:
· Prior to engaging in research funded through an external grant
· At least every four years
· Immediately if the University revises it FCOI policy that affects an Investigator’s requirements or if an Investigator is not in compliance with the policy or management plan.
10. Regarding Subrecipient Institutions/Investigators, the University will, where applicable, obtain a certification from the Subrecipient that its FCOI policy complies with regulations and/or incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to Subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements. Any Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to ONU in sufficient time to allow the University to report the FCOI to the appropriate agency to meet reporting requirements.
11. The following are the University’s reporting responsibilities:
a. The vice president for academic affairs will be responsible for reporting to the appropriate entity;
b. An initial report will be submitted prior to the University’s expenditure of any funds under the award;
c. ONU will inform the appropriate entity within 60 days for any interest that the University identifies as a FCOI subsequent to the University’s initial report under the award, and
d. Provide annual updates on any previously-identified FCOI during the duration of the project, including during an extension with or without funds;
e. ONU will provide information to the public on an identified FCOI held by senior key personnel via a publicly accessible Web site.
12. Should it be determined that an FCOI is not identified or managed in a timely manner, either due to the Investigator’s failure to disclose an SFI, failure by the University to review or manage an FCOI or failure to comply with the management plan, the University, within 120 days of the non-compliance determination, will complete a review of the Investigator’s activities and the project to determine bias in the design, conduct and reporting of such research. In the case of a PHS- or NSF-funded project, if bias is found, the University will notify submit a Mitigation Report to the appropriate entity.
*The term "investigator" means the principal investigator, and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or educational activities funded or proposed for funding. This may include collaborators or consultants.
**Significant financial interest is defined as:
A financial interest consisting of one or more of the following interests of the Investigator (or those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
a. Income in excess of $5,000 form a publicly-traded entity (a company whose stock is available for purchase by the general public) in the twelve months preceding the disclosure ;
b. Stock valued in excess of $5,000 at the time of disclosure in a publicly-traded entity.
c. A combination of the above two items (stock and income) that exceeds $5,000;
d. Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity (such as a start-up company);
e. Compensation that exceeds $5,000 from a non-publicly traded entity in the twelve months preceding the disclosure;
f. Income related to intellectual property rights/interests paid by any source other than the investigator’s current institution;
g. Any reimbursed or sponsored travel paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution of higher education or a research institute affiliated with such, a medical center, or an academic teaching hospital. The following must be disclosed: the name of entity sponsoring the travel and purpose, destination, and duration of the travel.
The term does not include
i. salary, royalties or other remuneration from Ohio Northern University;
ii. income from seminars, lectures or teaching engagements sponsored by public or non-profit entities;
iii. income from service on advisory committees or review panels for public or non-profit entities;
iv. Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights;
v. income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions;
vi. an equity interest that, when aggregated for the investigator and the investigator's spouse and dependent children meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
vii. salary, royalties or other payments that, when aggregated for the investigator and the investigator's spouse and dependent children, that does not exceed $5,000 during the previous twelve-month period.
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