VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

should allow the Investigator to conduct the research. Whether such compelling circumstances exit will depend upon the following facts that the Committee must take into account: a. The nature of the research, b. T he magnitude of the significant financial interest and the degree to which it is related to the research, c. The extent to which the significant financial interest could be directly and substantially affected by the research, d. The degree of risk to human subje cts involved that is inherent in the research protocol (if applicable), e. The extent to which the Investigator is uniquely qualified to perform a research study with important public benefit and f. The extent to which the interest is flexible to effective over sight and management. Such an example of a compelling circumstance would be an Investigator holding financial interests who is uniquely qualified by virtue of expertise and experience and the research could not be otherwise performed as safely or effect ively without this Investigator. In such a case, the Investigator could be permitted the opportunity to rebut the Committee’s presumption against conducting the research. MANAGEMENT OF FINANC IAL CONFLICTS OF IN TEREST Upon the determination that a financial conflict of interest exists, the Conflict of Interest Committee will develop and implement a management plan that shall spec ify the actions that have been, and shall be, taken to manage the financial conflict of interest. When the Committee implements a management plan, the Committee shall monitor the Investigator’s compliance with the plan on an ongoing basis until the compl etion of the research project. The Committee shall require periodic reviews, based upon requirements unique to each management plan, be conducted in an ethical and objective manner. These reviews will be assigned to a subcommittee or the full Committee, de pending upon the terms in each management plan. In each management plan, specific t erms shall be imposed to manage a financial conflict of interest . Such terms may include the following: a. Public d isclosure of financial conflicts of interest, such as when p resenting or publishing research results , may be required as part of a management plan. In addition, d isclosure of financial conflicts of interest directly to participants may be required for research projects in volving human subjects research. b. Modifications and c hanges to the r esearch p roject may be required in the management plan. The plan may require a change of responsibilities or may require the disqualification from participation in all or a portion of the research. c. R eduction or eliminatio n of the financial interest may be required . F or example, the Financially Interested Individual will sell all equity interests. The Conflict of Interest Committee may also consider requiring the severance of relationships that create significant financia l interests. 7.1. Monitoring The Committee may deem the a ppointment of an independent monitor to oversee the research project. This individual shall take measures to protect the design , conduct and reporting of the research against the bias resulting from t he financial conflict of interest. This individual may regularly audit the research, including the informed consent and enrollment process if human 7.

Financial Conflicts of Interest in Research Policy

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