VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R013

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. The 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 subjects 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 oversight 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 effectively 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 FINANCIAL CONFLICTS OF INTEREST Upon the determination that a financial conflict of interest exists, the Conflict of Interest Committee will develop and implement a management plan that shall specify 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 completion 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, depending upon the terms in each management plan. In each management plan, specific terms shall be imposed to manage a financial conflict of interest. Such terms may include the following: a. Public disclosure of financial conflicts of interest, such as when presenting or publishing research results, may be required as part of a management plan. In addition, disclosure of financial conflicts of interest directly to participants may be required for research projects involving human subjects research. b. Modifications and changes to the research project 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. Reduction or elimination of the financial interest may be required. For 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 financial interests. 7.1. Monitoring The Committee may deem the appointment 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 the 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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