Public Health Service (PHS) FCOI Regulations
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)
- Mandate. The 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.
- 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)
- Frequently Asked Questions. NIH has issued FAQs for the FCOI regulations.
►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.
- 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.
- 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:
- 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: Starting January 2024, Auburn University introduced a new electronic research administration and compliance system. All annual disclosures must now be submitted online through the Endeavor platform.
- New Endeavor Users
- Accessing Endeavor: Using Auburn credentials, log in to Endeavor, and navigate to the COI tab.
- Helpful Guide: Resources, Videos, and FAQs are available to help you access your Endeavor account, log in, and complete your Disclosure Profile.
- Even if you have no revisions, you must re-certify your Disclosure Profile.
- Auburn Students: Please contact coiadmin@auburn.edu if you need to submit a disclosure.
- External individuals: Please contact coiadmin@auburn.edu if you need to submit a disclosure.