PHS


PHS Financial Conflict of Interest (FCOI)


Effective August 24, 2012, the Public Health Service (PHS) requires institutions applying for or receiving PHS research funding by means of a grant, cooperative agreement or contract to be in compliance with the following new regulations: “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought & Responsible Prospective Contractors.” These regulations are commonly referred to as the “FCOI Regulations.”  The purpose of the FCOI Regulations is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS grants, cooperative agreements or contracts will be free from bias resulting from investigator financial conflicts of interest.  

PHS FCOI Regulations (2011)

Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought- 42 CFR Part 50, Subpart F

Responsible Prospective Contractors - 45 CFR Part 94

AU PHS FCOI Policy, Procedures, & Process

AU PHS FCOI Policy

AU PHS FCOI Procedure

AU PHS FCOI Flowchart

Resources

FAQs for 2011 Regulations

2011 FCOI Tutorial

Side-By-Side Comparison of 1995 and 2011 Regulations

NIH FCOI Webinar (Nov. 30, 2011)

NIH FCOI Reporting Requirements Webinar (August 14, 2012)

PHS Agencies

Training

Investigators are required to complete Financial Conflict of Interest Training:

1.    prior to engaging in research related to any PHS-funded grant or cooperative agreement;

2.    at least every four years thereafter; and

3.    immediately when any of the following apply:

a.    the University revises its PHS Financial Conflict of Interest Policy or Procedures in any manner that affects the requirements of Investigators;

b.    an Investigator is newly appointed at the University; or

c.    the University finds that an Investigator is not in compliance with the University’s FCOI Policy, Procedures, or a Management Plan.

Auburn University has contracted with the Collaborative Institutional Training Initiative (CITI) at the University of Miami to provide COI training. CITI is a web-based training program with content developed by a national consortium. The CITI COI program will ensure appropriate training and documentation related to COI requirements. 

CITI can be accessed at the following link: www.citiprogram.org

To access CITI, trainees must:

1.    Register for an individual account. (Registration Instructions)

2.    Affiliate with Auburn University.

3.    Enroll in the CITI COI Training. (Enrollment Instructions)

Disclosures

Click Here to Submit a Disclosure

Each Investigator planning to participate in PHS-funded research is required to complete a Disclosure Form which includes the Investigator's Significant Financial Interests (and those of the Investigator's Immediate Family) to the University’s PHS Reviewer no later than the time of application for PHS-funded research.

Each Investigator participating in PHS-funded Research is required to submit an updated Disclosure Form which includes the Investigator’s Significant Financial Interests (and those of the Investigator’s Immediate Family) at least annually, between August 1 and August 31, during the period of the award;  prior to the processing of a new award or modification to the scope of work; and within thirty days of discovering or acquiring a new Significant Financial Interest for themselves (or their Immediate Family). 

Reminder: Investigator includes the project director or principal investigator and any other person regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include for example, collaborators or consultants.

Auburn University has contracted with Health Care Compliance Strategies, Inc. (HCCS) to provide secure online submission, review, and processing of Investigator Disclosures through their COI-SMART System.  Access to COI-SMART is available through this link

Investigators: To activate a new COI-SMART account, please enter the requested information in this form. You will receive an automated e-mail from COI-SMART when your account has been created (typically within 1 business day).

Managers: To request manager access to COI-SMART, please call 334-844-8197 or e-mail coiadmin@auburn.edu.

Last Updated: 1/13/2014