VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

subjects research is involved. This individual may also require the financial interest to be escrowed until the investigational product has been approved and on the market for a specific time period.

7.2. Management Plan When the Committee determines that a Financially Interested Individual should be permitted to conduct research, a copy of the Committee’s managem ent plan describing fully the financial interest and any conditions imposed upon the research shall be provided to the appropriate associate dean and the department chair as well as to the President and Provost. The management plan shall also be provided to the Institutional Integrity Officer, the ORA director and, if applicable, the IRB chair. The principal investigator on the research shall also receive a copy if he or she is not the Financially Interested Individual. 7.3. Reconsideration If an Investigator objects to the terms of the management plan, he or she may submit promptly to the Institutional Integrity Officer a writte n request for reconsideration, which m ust specify the basis of the objection. The Institutional Integrity Officer will review the re consideration and will either refer the matter back to the Conflict of Interest Committee or consult with the Responsible Institutional Official to determine if the matter will be referred to the Committee or not. If the Investigator is not satisfied with the decision of the Institutional Integrity Officer and the Responsible Institutional Official, he or she may appeal to the President and Provost within five business days of the institutional officials’ decision. The President and Provost ’s decision is final, and there shall be no further appeal within the College. Should the matter be brought before the Committee, the Investigator may be required to attend the reconsideration session. The decision of the Committee re - review may be further appealed to the President and Provost. The Investigator must notify the Pres ident and Provost of any intended appeal within five business days of receiving notice from the Committee. The President and Provost ’s decision is final, and there shall be no further appeal within the College. 7.4. Disclosure during Ongoing Research D uring the course of an ongoing research project, if an Investigator discloses a new significant financial interest, or an Investigator who is new to participating in the research project discloses a significant financial interest to the College, the Institutiona l Integrity Officer shall review the disclosure of the significant financial interest. The Institutional Integrity Officer shall determine whether it is related to externally - funded research, determine whether a financial conflict of interest exists, and if so, submit the information to the Conflict of Interest Committee. The Committee shall then implement a management plan that stipulates the actions that have been, and will be, taken to manage such financial conflict of interest. This shall be completed within sixty days of receiving the disclosure from the Investigator. 7.5. Retrospective Disclosure If the College should identify a significant financial interest that was not disclosed appropriately by an Investigator, was not previously reviewed by the Coll ege during an ongoing externally - funded research project or was the consequence of an Investigator failing to comply with a financial conflict of interest management plan, the Institutional Integrity Officer shall review the significant financial interest, determine whether it is related to externally - funded research, determine whether a financial conflict of interest exists, and if so, submit the information to the Conflict of Interest Committee. The Committee then shall implement a management plan that s tipulates the actions that have been,

Financial Conflicts of Interest in Research Policy

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