VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R013

federal Common Rule (45.CFR.46 and 21.CFR.56) regardless of the source of research funding or whether the research is otherwise subject to federal regulation.

Responsible Institutional Official: Individual authorized by the College in human subjects research protections and who assumes the obligations of the FWA with the Office of Human Research Protections at the Department of Health and Human Services. Significant Financial Interest: A financial interest consisting of one or more of the following interests of the Investigator (and those of the I nvestigator’s spouse/domestic partner and dependent children) that reasonably appears to be related to the I nvestigator’s institutional responsibilities: a. Any financial interest in a publicly traded entity where the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship). Equity interest includes any stock, stock option or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value; b. Any financial interest in a non-publically traded entity where the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000 or when the Investigator (or the I nvestigator’s spouse/domestic partner or dependent children) holds any equity interest (e.g., stock, stock options or other ownership interest); or c. Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests. d. Travel related to an I nvestigator’s institutional responsibilities that i s either paid on behalf of the Investigator or not directly reimbursed to the Investigator. The Investigator must disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration and the monetary amount. This 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. Disclosure is required only by the Investigator and not the I nvestigator’s spouse/domestic partner or dependent children. The following financial interests are exceptions and are not included in the term significant financial interest: a. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment; b. Income from seminars, lectures or teaching engagements or income from service on advisory committees or review panels sponsored by a federal, state or local government agency, institutions of higher education, an academic teaching hospital, a medical centers or a research institute that is affiliated with an institution of higher education; c. Salaries, royalties or other remuneration paid by the College to the Investigator if the Investigator is currently employed or otherwise appointed by the College; and d. Rights in intellectual property assigned to the College, including the right to participate in the College’s royalties or in College’s equity pool if the equity interest is held and con trolled by the College.

Financial Conflicts of Interest in Research Policy

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