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Financial Conflicts of Interest In Research

Financial Conflicts of Interest In Research

Financial Conflicts of Interest In Research

Introduction

Welcome to Western University’s On-Line training program on Financial Conflicts of Interest (FCOI) in Research. Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research.  Western University’s Sponsored Project Financial Conflict of Interest Disclosure policy seeks to maintain the appropriate balance among all competing interests that have the potential to produce bias in the design, conduct, or reporting of the research or distort technology transfer transactions resulting from investigator FCOIs. In 2011, the Public Health Service (PHS) released revised FCOI regulations (42 CFR Part 50 Subpart F, Promoting Objectivity in Research) that apply to any institution receiving funds from a PHS entity.  In keeping with the revised regulations, all externally-funded “investigators” must successfully complete the online FCOI training tutorial below prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards.  The definition of an “investigator” includes the Principal Investigator (PI) and any other person, regardless of title or position, that the PI identifies as having some responsibility for the design, conduct, or reporting of the research.  The tutorial does not cover the provisions of the FCOI contract regulation provided at 45 CFR Part 94, Responsible Prospective Contractors.  Inquiries related to contracts can be directed to fcoicontracts@mail.nih.gov.  Although the regulation applies to other funding components within the PHS, this tutorial uses the National Institutes of Health (NIH) as an example.  Moreover, this tutorial is not intended in any way to substitute for the comprehensive review and impletmentation of all regulatory requirements.  Additional FCOI information related to grants and cooperative agreements is available at http://grants.nih.gov/grants/policy/coi/index.htm. At the end of the tutorial, there is a quiz.  You must obtain a passing score of 80% or higher on the quiz to receive credit for the training program.  The quiz may be re-taken as many times as necessary.  In this tutorial: 1) “regulation or FCOI regulation” refers to 42 CFR Part 50 Subpart F, Promoting Objectivity in Research which applies both to grants and cooperative agreements; 2) “disclosure” refers to the Investigator’s disclosure of Significant Financial Interests (SFIs) to their Institution; and 3) “report” refers to the Institution’s report of identified FCOIs to the NIH. Upon successful completion of the tutorial, notify Ms. Traci Meyer in the Office for Sponsored Programs at TraciM@westernu.edu (909-469-8334)  She will document your training and issue you a Certificate of Completion for your records.  Training must be completed at least every four years. Click on the tutorial below to begin. Resources: