Public Health Service (PHS) FCOI Regulations 

AU Policy      PI's Role      Timing      Training      Questionnaire

►Regulatory Requirements.  "To address the increasing complexities of the financial interests held by biomedical and behavioral researchers and the resulting interactions among Government, research Institutions, and the private sector, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) published revised regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors (commonly known as the Financial Conflict of Interest (FCOI) regulations)," effective August 24, 2012.  (NIH FAQs, Introduction)

  • MandateThe FCOI Regulations require that AU take "action to [manage, i.e.] address [all] financial conflict[s] of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias."  (42 C.F.R. §50.603)
  • Applicability.
    • PHS Research Funded or Proposed for Funding. The FCOI regulations establish standards to be followed by each institution "that is applying for, or that receives PHS research funding by means of a grant or cooperative agreement and [that apply] to each Investigator who is planning to participate in, or is participating in, such research." PHS "Research" includes any activity "for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement... such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award." (42 C.F.R. §§50.602-50.603)
      • Exemptions. Phase I Small Business Innovation Research (SBIR) Program and Phase I Small Business Technology Transfer (STTR) Program applications are exempt from the PHS FCOI Regulations. (42 C.F.R. §§50.602-50.603)
    • Plus Other Sponsor Funding. Various non-governmental foundations and entities have adopted the PHS FCOI Regulations and/or used the PHS FCOI Regulations in their award terms.
  • Frequently Asked Questions. NIH has issued FAQs for the FCOI regulations 

►AU PHS FCOI Policy and Procedures. AU has adopted and maintains a PHS FCOI Policy and PHS FCOI Procedures.


►PI Training and Disclosure Oversight Responsibilities.

  • Continuing Responsibilities. On a timely basis, from the proposal stage throughout the duration of a project subject to the FCOI regulations, Principal Investigators are responsible for:
    • 1. Identifying Investigators on a proposal, award and modification to the scope of work, and
    • 2. Ensuring Investigators take FCOI Training and submit FCOI Disclosure Questionnaires. 
  • Who is an Investigator? Consult the Guide to Identifying Investigators Subject to the FCOI Regulations to determine which persons on a project are Investigators.
    • The PI, Co-PI, PD, Co-PD and Senior/Key Personnel named in the proposal for funding, the award, a progress report or an award modification or in a subaward, subgrant, subcontract are always considered an Investigator.

►When to Train and Disclose.

  • Before Proposal Submission. Each Investigator planning to participate in research subject to the FCOI regulations and each Investigator identified by the PI on a particular proposal submission subject to the FCOI regulations is required to:
    • 1. Complete FCOI Training, and
    • 2. Submit a FCOI Disclosure Questionnaire including the Investigator's Significant Financial Interests and those of their Immediate Family. (Capitalized terms are defined in the AU PHS FCOI Procedures.)
  • Disclosure after Proposal Submission
    • 1. Newly Added Investigator. If the PI identifies any Investigators who did not submit a Disclosure Questionnaire prior to proposal submission, they must submit a Disclosure Questionnaire before engaging in research
    • 2. Recertification/Revision of Prior Disclosure. Each Investigator is required to recertify/revise their Disclosure Questionnaire at certain points during the reporting year:
      • Before the processing of a new award, and
      • Before the processing of a modification to the scope of work, and
      • Within thirty (30) days of discovering or acquiring a new Significant Financial Interest for themselves or their Immediate Family.
    • 3. Annual Disclosure. Investigators are required to submit a Disclosure Questionnaire annually.
  • Training after Proposal Submission
    • 1. Newly Added Investigator. If the PI identifies any Investigators who did not complete FCOI Training prior to proposal submission, they must complete the FCOI Training before engaging in research
    • 2. Expiration of Training. Each Investigator is required to complete FCOI Training at least every four (4) years.
    • 3. In Other Circumstances. An Investigator must complete FCOI Training immediately when any of the following apply:
      • The University revises its PHS Financial Conflict of Interest Policy or Procedures in any manner that affects the requirements of Investigators, or
      • An Investigator is newly appointed at the University; or
      • The University finds that an Investigator is not in compliance with the University’s FCOI Policy, Procedures or a Management Plan. ​​

►How to Train: Online via CITI.

  • New CITI Users. Use this Guide to help you register, enroll in the Conflict of Interest course and complete your FCOI Training.  
  • Previously Registered CITI Users. If you need to complete FCOI training, login to CITI, click "Add a Course or Update Learner Group" and add the Conflict of Interest course.
  • Training Expiration and Extension. The FCOI Training Certificate earned after completing the Conflict of Interest course expires after four (4) years. Completing the FCOI Refresher course extends your Training Certificate for another four (4) years.
    • Automatic Refresher Enrollment. You should receive an email from CITI informing you that your FCOI training is expiring and enrolling you in the FCOI Refresher course necessary to maintain your FCOI Training Certificate. Use the login in the email to access CITI and extend your Training Certificate.
  • Transferring Training Credits to Auburn University. If you would like to receive credit at Auburn University for CITI Conflict of Interest modules previously taken at another institution, follow these CITI requirements to affiliate with AU and transfer credit. Modules transferred may or may not match the required modules in the AU Conflict of Interest course. You may need to complete additional modules to get full credit for the AU course.

►How to Disclose: Online via COI-SMART.

  • New COI-SMART Users.
    • Helpful Guide. Use this Quick Reference Card to help you request an account, log in and complete your Disclosure Questionnaire in COI-SMART. It includes FAQs.
    • Activating your Account. To activate a new COI-SMART account, enter the requested information in this form. You may need to enter "auburn\" before your AU user name.
      • We make every effort to set up each new account within 1 business day after receiving the request.
      • After account setup, you will receive a "Welcome" email from COI-SMART with directions on how to proceed.
  • Previously Registered COI-SMART Users. 
    • Accessing COI-SMART. Use single sign-on in AU Access by clicking the COI-SMART button under the My Funding tab or login to COI-SMART.
    • Recertification/Revision. Use this Step-by-Step Guide to avoid common, time-consuming errors!
      • Even if you have no revisions, you must recertify your Disclosure Questionnaire by revising the certification question at the very end of the Questionnaire.
    • Annual Disclosure. To complete your annual Disclosure Questionnaire, access COI-SMART and:
      • Click "My Questionnaires" in the left sidebar.
      • Click the most recent Questionnaire, found at the end of the list.
      • Proceed through the questions, provide the Certification at the end and submit the Questionnaire.