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Conflict of Interest Shilene Johnson- Research Compliance Specialist
Research Integrity Office/Office of Accountability and Compliance Located at: 620 W. Lexington street
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Primary Responsibility
The Office manages the Process for Financial Conflict of Interest Review and Management under: Federal Regulations (U.S. Public Health Service Regulations) State Law (State Public Ethics Law) Primary responsibility of the office
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State Public Ethics Law
Financial relationship with an entity that has a business relationship with the University (typically an investigator has a financial interest in the research sponsor). Relationships are disclosed to the COI Officer Require a review by the campus Final approval from the President of the University. Typically an investigator has a financial interest in the research sponsor. An example would be an investigator has a stock in Merck and is conducting research that involves a drug made by Merck
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Federal U.S. Public Health Services (PHS)
Any person, regardless of title or position, participating in the design, conduct, or reporting of the PHS funded research must adhere to two requirements: Disclosure of Significant Financial Interest (SFI) Mandatory Conflict of Interest (COI) Training Federal Regulations (U.S. Public Health Services)- PHS
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Conflict of Interest (COI) Training
Who must complete: Each Investigator who is planning to participate in, or is participating in, PHS-Funded Research must complete training.
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When do I have to complete Training?
Prior to Engaging in PHS-Funded Research Every four (4) years
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Significant Financial Disclosure Form
Any Significant Financial Interest (SFI) of an investigator (and those of the investigator’s spouse and dependent children) during the preceding twelve months that reasonably appears to be related to the Investigator’s Institutional Responsibilities such as: Any money paid for work or service from any entity during the twelve months preceding the disclosure (ex: consulting fees, paid authorship, intellectual property rights, equity interest, reimbursed travel etc. Even if you have nothing to disclose, you still have to complete the form if you are participating in the design, conduct, or reporting of any PHS funded research
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When do I have to complete disclosure ?
At or before the time of submission of an application for PHS-Funded Research Annually Anytime you Acquire a new Significant Financial Interest (SFI) When do I have to complete the disclosure form Mention: Training is due every four years
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Where can I find the training and disclosure form?
University of Maryland, Baltimore Office of Accountability and Compliance Conflict of Interest UMB PHS Training module and SFI Disclosure Form You can also find policies and procedures and a list of all PHS agencies on the website
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PHS Requirements YOU MUST complete COI training every four years.
YOU MUST complete a disclosure form even if you have nothing to disclose. YOU MUST complete a SFI disclosure form annually. YOU MUST include “all” monetary value on the disclosure form. UMB has a 0.00 Threshold
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For Additional Questions Please Contact: Shilene Johnson, MPH Research Compliance Specialist Office of Accountability and Compliance 620 W. Lexington Street or Alison Watkins, JD, MS UMB Conflict Of Interest Officer Office of Accountability and Compliance 620 W. Lexington Street
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Thank You
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