1. Financial Conflict of Interest (FCOI) Training in Public Health Service Funded Research
Colorado State University
Conflict of Interest Committee (COIC)
July, 2012

2. Purpose: Promoting Objectivity in Research
The Public Health Service (PHS) has issued revised financial conflict of interest regulations that apply to PHS-funded sponsored projects at CSU. The revised regulations “promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.”
To view the complete regulation, please go to:

3. Conflict of Interest as Defined at CSU
Training Objectives
This tutorial is intended to meet the PHS requirement in the 2011 revised Federal regulation on Financial Conflict of Interest (FCOI) for investigator training. The tutorial includes:
Conflict of Interest as Defined at CSU
Major Changes in PHS FCOI Guidelines
How to Disclose: Fundamental Steps for Disclosure at CSU
Conflict of Interest Committee contact information
Training Review Questions
Training Completion Acknowledgement

4. Tip: If you have questions about this training, please contact:
For questions regarding application of the regulation:
For questions regarding technical difficulties viewing the training or completing the training review questions and certificate: ______-

5. Conflict of Interest at CSU
External obligations, financial interests and activities that may conflict or interfere or may appear to conflict or interfere with the employee’s obligation to the University.
--Academic Faculty and Administrative Professional Manual
“The mere perception of conflict of interest can cause lasting injury to the reputation of the employee and the University, even when subsequent information shows those perceptions to be unfounded.”
Academic Faculty and Administrative Professional Manual
Tip: Perception is important when determining if a potential Conflict of Interest exists.

6. Applicability and Impact
This regulation is applicable to each Institution that is applying for, or that receives, PHS research funding by means of grant, cooperative agreement, or contact and to each Investigator who is planning to participate in such research. An Institution (and Investigator) must be in full compliance with the regulation no later than August 24, Significant changes in requirements include:
Decrease in financial interest disclosure threshold from $10K (CSU’s current standard) to $5K.
Disclosure of certain reimbursed travel
Disclosure of income from certain seminars, lectures, or teaching engagements
Public accessibility through written response to inquiries related to COI
Enforceable policy on financial conflicts of interest that is PHS-compliant
Mandatory COI training at least every 4 years

7. New PHS FCOI Guidelines (click on the box for more information)
Significant
Financial Interests
Travel
Subrecipient
Institutions
Public
Accessibility
FCOI
Training
Requirement
Other Considerations
New Federal regulations-no choice!

8. How to disclose: Fundamental Steps for Disclosure at CSU
Assessment
Management
Update
Employee fills out Role &Responsibility Survey
Including PHS survey where applicable
R&R Survey
-Annual
-Event based
-Employee Responsibility
-PHS Addendum if
applicable
Multi-tiered review includes:
Dept Head review
Dean review
COIC review
College files w/annual update if no COI management plan is needed
Research Associate Dean
Conflict of Interest Committee
-Financial Conflict of Interest*
-Conflict of Commitment (time)*
-Potential to Compete w/CSU*
-Potential adverse impact on students*
*Real or Perceived

9. Conflict of Interest Committee (COIC)
Provides assessment and recommendations to the Provost on COI issues that are brought to the attention of the Provost by the Dean of a College. Suggested contacts are:
Kathi Delehoy
Co-Chair, COIC
Senior Assoc VP for Research
Tim Gallagher
Chair, Faculty Council
Dan Bush
Vice Provost for Faculty Affairs
Linda Schutjer
Office of General Counsel
COI information and resources can be found on the Provost’s website at:
A full roster of the COIC is available upon request.

10. Tip: Handy Reference Guides
PHS investigators may find the following to be helpful laboratory reference guides:
NIH FCOI Tutorial:
Office of Extramural Research FAQs:
CSU COI Website and PHS Addendum Definitions:
A Training review follows. Completion of the training and review achieves training compliance. Mastery scores are not being retained. Please print and send your completion certification to:

11. Training Review Questions
1. The perception of a FCOI is just as significant as an actual FCOI.
True False
PHS-funded investigators must disclose the following as a significant financial interest if applicable to the Investigator, the Investigator’s spouse (or domestic partner) or dependent children: The value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $
You are not required to disclose travel that is reimbursed or sponsored by a a federal, state or local government agency or an Institution of higher education but you should track your travel.
For incorrect answers: That is incorrect. Please try again.
For correct answers: That is correct. Click to next question or slide to proceed.

12. Training Review Questions
1. The perception of a FCOI is just as significant as an actual FCOI.
True False
PHS-funded investigators must disclose the following as a significant financial interest if applicable to the Investigator, the Investigator’s spouse (or domestic partner) or dependent children: The value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $
You are not required to disclose travel that is reimbursed or sponsored by a a federal, state or local government agency or an Institution of higher education but you should track your travel.
For incorrect answers: That is incorrect. Please try again.
For correct answers: That is correct. Click to next question or slide to proceed.

13. Training Review Questions
Subrecipients must comply with PHS regulations pertaining to FCOI, including regulations concerning subrecipient reporting obligations.
True False
An employee may be “interested” in a contract and still not violate the statute if the contract results from a competitive bid process or disclosure has been made to the Provost’s Office.
6. The Role & Responsibility Survey is the first step in the disclosure process.
For incorrect answers: That is incorrect. Please try again.
For correct answers: That is correct. Click to next question or slide to proceed.

14. References
The COIC would like to offer its thanks to the following institutions for their resources:
Iowa State:
Columbia University:
Office of Extramural Research FAQs:

15. Acknowledgement
I have read and understand the material presented in the requirements of a PHS-funded investigator presented in this training in regards to financial conflict of interest (FCOI).
Please print this screen and sign below.
__________________________ ____________
Signature Date
Please send this acknowledgement to: