Conflict of Interest Primary Responsibility The Office manages
Conflict of Interest
Primary Responsibility The Office manages the Process for Financial Conflict of Interest Review and Management under: o Federal Regulations (U. S. Public Health Service Regulations) o State Law (State Public Ethics Law)
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). o Relationships are disclosed to the COI Officer o Require a review by the campus o Final approval from the President of the University.
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: o Disclosure of Significant Financial Interest (SFI) o Mandatory Conflict of Interest (COI) Training
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.
When do I have to complete Training? Prior to Engaging in PHS-Funded Research Every four (4) years
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: o 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.
When do I have to complete disclosure ? o At or before the time of submission of an application for PHS-Funded Research o Annually o Anytime you Acquire a new Significant Financial Interest (SFI)
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
PHS Requirements YOU MUST complete COI training every four years. YOU MUST complete a disclosure form even if you have nothing disclose. YOU MUST complete a SFI disclosure form annually. YOU MUST include “all” monetary value on the disclosure form.
For Additional Questions Please Contact: Shilene Johnson, MPH Research Compliance Specialist Office of Accountability and Compliance 620 W. Lexington Street 410 -706 -4934 shilene. johnson@umaryland. edu or Alison Watkins, JD, MS UMB Conflict Of Interest Officer Office of Accountability and Compliance 620 W. Lexington Street 410 -706 -1266 athom 001@umaryland. edu
Thank You
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