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Conflict of Interest: Difference between revisions
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#When Covered Persons have significant financial interests related to their institutional responsibilities, present information to the COI committee for potential COI management plan creation. | #When Covered Persons have significant financial interests related to their institutional responsibilities, present information to the COI committee for potential COI management plan creation. | ||
#'''Report FCOI to PHS'''. When the COI committee has implemented a COI management plan for PHS-funded research, update the PHS e-Commons with the FCOI report provided by the COI committee. Provide initial, annual and revised FCOI reports, if applicable for both UNMC and its subrecipients. Revised FCOI reports shall be submitted within 60 days of identification for new Investigators added to a grant, or newly identified FCOIs for existing investigators. The FCOI report shall contain the following elements: | #'''Report FCOI to PHS'''. When the COI committee has implemented a COI management plan for PHS-funded research, update the PHS e-Commons with the FCOI report provided by the COI committee. Provide initial, annual and revised FCOI reports, if applicable for both UNMC and its subrecipients. Revised FCOI reports shall be submitted within 60 days of identification for new Investigators added to a grant, or newly identified FCOIs for existing investigators. The FCOI report shall contain the following elements: | ||
##The role and principal duties of the conflicted Investigator in the research project; | |||
##Conditions of the management plan; | |||
##How the management plan is designed to safeguard objectivity in the research project; | |||
##Confirmation of the Investigator's agreement to the management plan; | |||
##How the management plan will be monitored to ensure Investigator compliance; and | |||
##Other information as needed. | |||
#'''Conduct retrospective review.''' If UNMC identifies a significant financial interest that was not disclosed by a research Investigator in a timely manner, or was not reviewed by UNMC, the COI officer shall, within sixty (60) days: review the significant financial interest and determine whether it is related to PHS-funded research. The COI committee shall determine whether a financial conflict of interest exists, and, if so, implement an interim COI management plan. Within 120 days, the COI committee shall complete a documented retrospective review of the research Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of non-compliance was biased in the design, conduct or reporting of such research. The documented review shall contain all of the elements required by the PHS regulations. | #'''Conduct retrospective review.''' If UNMC identifies a significant financial interest that was not disclosed by a research Investigator in a timely manner, or was not reviewed by UNMC, the COI officer shall, within sixty (60) days: review the significant financial interest and determine whether it is related to PHS-funded research. The COI committee shall determine whether a financial conflict of interest exists, and, if so, implement an interim COI management plan. Within 120 days, the COI committee shall complete a documented retrospective review of the research Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of non-compliance was biased in the design, conduct or reporting of such research. The documented review shall contain all of the elements required by the PHS regulations. | ||
#'''Reporting Bias & Mitigation Report.''' If bias is found with the design, conduct or reporting of PHS-funded research, the COI Officer shall notify the PHS awarding component promptly and submit a Mitigation Report containing the retrospective review information and a description of the impact of the bias on the research project and UNMC's plan of actions taken to eliminate or mitigate the effect of the bias. | #'''Reporting Bias & Mitigation Report.''' If bias is found with the design, conduct or reporting of PHS-funded research, the COI Officer shall notify the PHS awarding component promptly and submit a Mitigation Report containing the retrospective review information and a description of the impact of the bias on the research project and UNMC's plan of actions taken to eliminate or mitigate the effect of the bias. | ||