APPENDIX TO POLICY

Required Disclosures

Employees must make the following disclosures, whether or not required by the terms of a conflict management plan.

Activity in which disclosure is requiredAction required or additional information
In the context of clinical health care Employees who have a significant financial interest or business interest in a business entity which manufactures or distributes pharmaceuticals, medical devices, or other health care products, must provide a disclosure of that business or financial interest to all patients for whom the employee prescribes or uses a branded product of that business. The same disclosure must be made when the business interest or significant financial interest is held by a family member. The disclosure may be made orally or in writing, at the discretion of the employee.  In either case documentation of the disclosure must be made, and the patient must be provided with an opportunity to discuss the conflict with the employee.
To research sponsors Employees must disclose relevant business or significant financial interests to sponsors of research as required by the sponsor.
When submitting a paper for publication Employees must comply with the journal’s disclosure requirements. If required to disclose a business or significant financial interest in publications pursuant to a conflict management plan, the employee must use the recommended (or substantially similar) disclosure language set forth in the management plan.
In the context of a public appearance Employees must disclose relevant business or significant financial interests when they make an appearance, either in person or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issue or matter up for consideration, discussion, or action.  If required to disclose a business or significant financial interest in presentations pursuant to a conflict management plan, the employee must use the recommended (or substantially similar) disclosure language.
To student or trainees Employees must disclose relevant business or significant financial interests to students when teaching about the products or processes developed, marketed, or sold by the business in which they hold the interest. For students the disclosure can be made in a course syllabus.
In the context of non-compliance with PHS regulations In any case in which the Department of Health and Human Services determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an employee with a financial conflict of interest (FCOI) that was not managed or reported by the University as required by PHS regulations, the employee must disclose the FCOI in each public presentation of the results of the research and must request an addendum to previously published presentations.
When serving on supplier selection committees Employees must disclose relevant business or financial interests when participating in supplier selection decisions. The term “relevant business or financial interests” means financial and business interests held by the employee or a member of the employee’s family as well as relevant financial interests associated with monetary contributions made by a business entity to that employee’s University department.
When required by the terms of a conflict management plan Covered individuals must disclose relevant business or significant financial interests under the terms of a conflict management plan, and retain documentation of the disclosures while the plan remains in effect.

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