Related Conflict of Interest Policies

Title : Research Conflict of Interest - Disclosure, Review and Management Number : 1362, Version : 12

C. Conflict of Interest Official (COI Official): The Human Protections Administrator as specified in BH’s Federal Wide Assurance (FWA) or such other individual as may be appointed by the Chief Clinical Officer of BH. The COI Official may assign, in writing or by electronic mail, some or all of their obligations under this policy to one or more designees. D. Conflicted Party: An Investigator or other Covered Individual with a Conflict of Interest or a Covered Individual reporting/associated with an Institutional COI. E. Covered Individual: Any employees (full or part time, or non-salaried), staff, students, fellows, trainees, independent contractors, their agents or an administrator who, within the scope of their position within BH or subject to BH’s designated IRB, conducts, reports, oversees, or publishes Research. Covered Individual includes a related trust, organization or other enterprise in which a person or a person’s Immediate Family Member, alone or together, has an interest. Covered Individual includes their Immediate Family Member. The Investigator is a Covered Individual. Additionally, an Investigator who is a physician has medical privileges (through Medical Staff Services) at the BH facility, and who is conducting Research at such BH facility is a Covered Individual. Where the COI Official believes that an Investigator should not be considered a Covered Individual the COI Official shall obtain a waiver with regard to such Investigator in accordance with Article IV.G of this policy. F. Disclosable Financial Interests and Arrangements: The financial interests, arrangements, and payments that must be disclosed are described below. The dollar amounts that trigger reporting are the combined financial interests of the investigator, spouse, and dependent children. 1. Any financial arrangement entered into between the sponsor of the covered clinical study and the investigator involved in the study in which the value of the compensation could be influenced by the study outcome (i.e., compensation that could be higher for a favorable outcome than an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest). 2. A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright or licensing agreement. 3. Any equity interest in any sponsor of the covered clinical study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for one year following completion of the study. 4. Any equity interest in any sponsor of the covered study if the sponsor is a publicly held company and the interest exceeds $50,000 in value. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for one year following completion of the study. 5. Significant payments of other sorts (SPOOS) are payments that have a cumulative monetary value of $25,000 or more and are made by any sponsor of a covered study to the investigator or the investigator’s institution during the time the clinical investigator is carrying out the study and for one year following completion of the study. This would include payments that support activities of the investigator (e.g., a grant to the investigator or to the institution to fund the investigator’s ongoing research or

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