VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

and will be, taken to manage such financial conflict of interest going forward. This shall be completed within sixty days of receiving the disclosure from the Investigator.

In addition, the College shall complete a r etrospective review of the Investigator’s activities and the externally - funded research project to determine if any research conducted during the time period of the noncompliance was biased in the design, conduct or reporting of such research. This shall take place within 120 days of determination of non - compliance. The College shall document the retrospective review and shall include all of the following elements: a. Project title and award or contract number, b. Principal investigator name , c. Name of the Invest igator with the financial conflict of interest, d. Name of the entity with which the Investigator has a financial conflict of interest, e. Reason(s) for the retrospective review, f. Detailed methodology used for the retrospective review and g. Findings and conclusions from the review. For all research projects funded by Public Health Services (PHS) agencies, additional reporting requirements must be met for any financial conflict of interest findings. The ORA shall provide to the PHS awarding agency a financial conflict of interest report regarding all the Investigator’s significant financial interest found by the College, and ensure that the College has implemented a management plan in accordance with the federal requirements ( 42.CFR.50 Subpart F ). Reporting must be done: a. Prior to the College’s expenditure of any award f unds, b. During the period of the award, within 60 days of identifying a new financial conflict of interest for existing investigators, c. During the period of the award, within 60 days of identifying a new financial conflict of interest for an investigator new to the project an d d. Annually during the duration of the project . 8. R EPORTING R EQUIREMENTS FOR PHS - FUNDED R ESEARCH 8.1. Reporting Elements Any reports required as described above must include sufficient information to enable the PHS awarding agency to understand the nature and extent of the conflict, and to assess the appropriateness of the College’s management plan. Eleme nts must include, at a minimum: a. Project award number and p rincipal investigator name , b. Name of the Investigator with the financial conflict of interest , c. Name of the entity with which the Investigator has a financial conflict of interest , d. Nature of the signi ficant financial interest in research, e. Approximate dollar value of the significant financial interest in research , f. Description of how the financial interest relates to the research, g. Description of the key elements of the College’s management plan (role and duty of the Financially Interested Individual, conditions of the plan, design of the plan to safeguard objectivity in the research, confirmation of the Investigator’s agreement to the plan, detail of monitoring plan to ensure compliance ) and h. Other informa tion as needed. Note that for those cases in which the College eliminated a conflict prior to the expenditure of funds, the College does not have to submit a financial conflict of interest report to the PHS awarding agency.

Financial Conflicts of Interest in Research Policy

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