Conflict of Interest (COI) Objectives: Provide an overview of financial conflict of interest (FCOI) related to research activities at Gillette Describe Gillette’s COI reporting requirements when participating in research activities Explain how COIs are managed when identified

Conflict of Interest It is essential to maintain transparency about external financial relationships when conducting research within a clinical setting such as Gillette. Everyone at Gillette is held to an ethical standard to ensure that outside activities do not influence their professional judgment in research related activities. Research Administration and the Research Committee at Gillette will work with individuals to determine if a conflict exists and if so, help them manage it. This allows those to continue the pursuit of relationships within the industry and sponsors to advance their careers, to benefit both themselves and Gillette for years to come.

Conflict of Interest A conflict of interest arises when activities, associations or relationships outside of Gillette conflict with responsibilities to Gillette and the people we serve. (Gillette Code of Business Conduct) Having a conflict of interest is not prohibited or even necessarily considered a problem, however, in order to maintain transparency, the conflict must be disclosed and either eliminated, reduced, or managed by implementing a plan moving forward. This online training will explain the details of FCOI, and how to report and when possible how to develop a management plan.

What is a Financial Conflict of Interest (FCOI) related to research? When an investigator or family member has a significant financial interest that could potentially affect professional judgment when participating in a research project An investigator includes any person involved in a substantive and meaningful way in the design, conduct, or reporting of research findings. A family member includes a spouse, domestic partner, or dependent children

What is a significant financial interest related to research? Something that may influence the Investigator’s research at Gillette that is not paid for by the funding institution or by a federal, state, or local government agency, academic teaching hospital, medical center or research institute Detailed examples are outlined on the next slide

Significant financial interests Salary or payments for services (consulting fees, honoraria, paid authorship) that exceeds $5,000 Equity interest (stock, stock options, or other ownership interest) received from a business entity and the current value exceeds $5,000 Intellectual property rights Reimbursed or sponsored travel related to the institutional responsibilities if paid on behalf of the investigator by an outside business entity Royalties exceeding $5,000

The following do not need to be disclosed: Salary, royalties, or other compensation from Gillette Income from seminars, lectures, or teaching sponsored by public or nonprofit entities Income from service on advisory committees or review panels for public or nonprofit entities Income from mutual funds and retirement accounts as long as the investigator does not directly control the investment decisions

Financial Conflict of Interest Reporting All researchers involved in projects with Gillette must complete a Financial Disclosure for Research Form prior to beginning, within 30 days of a qualifying change, and then annually regardless of whether they have any interests to report. Disclosure form can be found on GilletteNet under Forms Report forms cover a two year period If you have anything to disclose you will be directed to complete a Management of Conflict of Interest Form found on GilletteNet under Forms.

If You Report a Significant Financial Interest Your Management of Conflict of Interest form will be reviewed by the Research Committee who will decide if a conflict exists, and if so, how the conflict can be eliminated, reduced or managed. The conflict will be addressed by the creation of a management plan that will be shared with the investigator and kept on file with Research Administration

Training Requirements This training must be completed at least every 4 years, or more often if any significant changes occur to the material.

Quiz Question 1 A physician owns equity in a company that is related to Gillette Children's valued at $6,000. The physician does not have any sponsored awards from this company and does not do any consulting for them. Is this considered a significant financial interest? A)Yes B)No

Quiz Question 1 A physician owns equity in a company that is related to Gillette Children's valued at $6,000. The physician does not have any sponsored awards from this company and does not do any consulting for them. Is this considered a significant financial interest? A)Yes The correct answer is A. The threshold is a minimum of $5,000 in equity for individuals to be considered a significant financial conflict of interest. The correct answer is A. The threshold is a minimum of $5,000 in equity for individuals to be considered a significant financial conflict of interest. B)No

Quiz Question 2 A physician is asked to speak at several Gillette Children's sponsored events and is given compensation in the amount of $10,000 to do so. Is this considered a significant financial interest that needs to be disclosed? A)Yes B)No

Quiz Question 2 A physician is asked to speak at several Gillette Children's sponsored events and is given compensation in the amount of $10,000 to do so. Is this considered a significant financial interest that needs to be disclosed? A)Yes B)No The correct answer is B. Income from seminars, lectures, or teaching sponsored by public or nonprofit entities does not need to be reported. The correct answer is B. Income from seminars, lectures, or teaching sponsored by public or nonprofit entities does not need to be reported.

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