VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

In general, the Significant Financial Interests related to research, as defined in Section 3, shall be reviewed by the Conflict of Interest Committee, as these are likely to con stitute a financial conflict of interest unless there are factors that would reasonably prevent any direct or significant effect on the design, conduct or reporting of the research. The Responsible Institutional Official may also choose to submit for Comm ittee review other types of Significant Financial Interests not described in Section 3 or instances where an Investigator has more than one type of Significant Financial Interest related to the research. 6.2. Determining Financial Conflict of Interest The Inst itutional Integrity Officer, along with the Chair of the Conflict of Interest Committee, the Responsible Institutional Official and the Conflict of Interest Committee , as appropriate, shall determine whether an Investigator’s significant financial interest is related to research, and if related, whether the interest is a financial conflict of interest. An investigator’s significant financial interest is related to research when the officials reasonably determine that the significant financial interest: a. Coul d be affected by the research, or b. Is in an entity whose financial interest could be affected by the research. The officials shall determine that a financial conflict of interest exists when they reasonably determine that the significant financial interest could directly and significantly affect the design, conduct or reporting of the research. The Conflict of Interest Committee will conduct a thorough review of each conflict and will make recommendations for resolution. The Committee may confer with other officials as it deems appropriate, including the Responsible Institutional Official and the President and Provost. The Committee shall communicate all findings in writing to the Investigator, the President and Provost and, if applicable, the College IRB. The written communication will include one of the following opinions: a. Review revealed the Investigator is not a Financially Interested Individual, b. Review revealed the Investigator is a Financially Interested Individual and may not conduct the researc h, or c. Review revealed significant financial interests in research but a plan has been approved that sets forth conditions for management and oversight of the research, which will allow the Investigator to proceed with the research. In cases of human subje cts research where potential conflicts are identified, the Institutional Integrity Officer and/or the Chairman of the Conflict of Interest Committee will notify the College IRB Chair of its determination: a. The Investigator is not a Financially Interested In dividual, b. The Investigator is a Financially Interested Individual; however, full disclosure of this to the research subjects is sufficient to allow the research to continue, or c. The potential conflict of interest has been referred to the Conflict of Interes t Committee for review, and IRB approval cannot be granted until the Committee has made a determination about whether the research can proceed. Should the IRB and the ORA receive any information concerning the significant financial interests in research, they should forward that to the Conflict of Interest Committee 6.3. Procedures on Compelling Circumstances For any conflict in front of the Committee, the Investigator shall have the opportunity to respond in person via a presentation to the Committee to demon strate that compelling circumstances exist that

Financial Conflicts of Interest in Research Policy

Page 7 of 13