Conflict of Interest Management Plan. You disclosed one or more significant financial interest(s) related to your university responsibilities.

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Transcription:

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 nonpublically 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 - $19,999 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?

What is their relationship to the research? Who will serve on your COI oversight committee? The oversight committee should be comprised of three members, one of whom will serve as chair and none of whom should have any relationship to the project. The majority of this committee should be comprised of individuals from the University of Kentucky and members may come from outside of your chain of command, such as a different department or different college. Provide name, title, and area of expertise of each member. Additional Requirements: I will disclose my financial interest in any presentation or publication resulting from the research. I will provide my COI oversight committee copies of any presentations/publications from research that is impacted by my financial conflict for review prior to release. Disclosure of financial conflicts of interest related to the publication or presentation is required irrespective of the meeting organizer s or journal s policy for such disclosure. For examples of where disclosures may be included within your publication or presentation, please contact Kelley Davis, COI Administrator. I will disclose to my COI oversight committee plans for all patents generated from the project. All intellectual property will go through UK.

If the award is from a company, I will perform only the work described in the agreement to the UK Research Foundation in university facilities. Company activities will be maintained separately and will not use university resources. 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