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The procedures for researchers at the University of Kentucky to disclose and manage potential conflicts of interest (COI) related to their research projects. Researchers are required to disclose significant financial interests (SFI) and describe how each SFI relates to their research. The document also outlines the steps to safeguard objectivity in research and the roles and duties of those involved. The management plan includes provisions for disclosing financial interests in presentations, publications, and patents, as well as annual reporting requirements.
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Conflict of Interest Management Plan
You disclosed one or more significant financial interest(s) related to your university responsibilities.
Describe the significant financial interest (SFI) and explain how each SFI relates to your active and pending research projects. Include information about any of the following categories that relates to your specific SFI: equity interest in stock (provide % if non- publically traded), stock options, consulting or honoraria fees, related intellectual property rights and interests, e.g. patents, copyrights, royalties, licensing agreements, etc, and any executive role if a company is involved:
The estimated value of each financial interest that relates to your research:
$0 - $4,999 $5,000 - $9,999 $10,000 - $19,
Amounts between $20,000 - $100,000 by increments of $20,000 ____________
Amounts above $100,000 by increments of $50,000 ___________
Or : a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Describe how the management plan is designed to safeguard objectivity in your research?
What are your roles and principal duties in each research project impacted by your COI?
The proposed management plan is as follows:
Will other university personnel be involved (including faculty)? Yes _______
No _______
If yes, provide to OSPA, the signed University Personnel Notification form
Will graduate students be involved where you are Chair of their thesis committee? Yes ______ No _____
If yes, provide the name of an un-conflicted co-chair for each graduate student. The co-chair may be a member of the student’s existing thesis committee and should be chosen in consultation with the student.
Note: The Graduate School must be notified of the appointment of a co-chair
Does your conflict involve human subject research or clinical investigation?
Yes _____ No ______
If yes, how will you inform the clinical trial volunteers?
Who will perform data analysis on study results?
The COI oversight committee must submit to OSPA a brief annual report which outlines the review activities conducted during the year, including reviewing any presentations/publications before release, any patent applications, and research results for bias. It is the responsibility of the conflicted investigator to provide the local oversight committee with any other research related information they may request. The annual report shall summarize the committee’s oversight activities. Failure to submit an annual report will result in the RCOIC’s recommendation to OSPA to freeze active accounts and not establish new accounts until the annual report is approved by the RCOIC. A copy of the plan will be provided to committee members after it is approved and signed by the Vice President for Research.
If you are participating in sponsored research, you must submit an updated disclosure of Significant Financial Interest (SFI) within 30 days of discovering or acquiring a new SFI. If you have any Federal Public Health Service funded research this requirement includes reporting any sponsored travel within 30 days of completion of the trip (this requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.)
Recommendations of the RCOIC with regard to the proposed COI management plan do not imply compliance with all UK regulations. (For contracts between UK Healthcare employees and outside entities, the contract must be reviewed by UK Healthcare. The UK Healthcare contact person is Brett Short, Corporate Compliance Officer.)
Investigator’s name Date
I concur with the COI management plan:
________________________ Associate Dean for Research