PHS FCOI Training Template - Colorado State University

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Financial Conflict of Interest (FCOI)
Training
in Public Health Service Funded Research
Colorado State University
Conflict of Interest Committee (COIC)
July, 2012
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: http://grants.nih.gov/grants/policy/coi/
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:
1. Conflict of Interest as Defined at CSU
2. Major Changes in PHS FCOI Guidelines
3. How to Disclose: Fundamental Steps for Disclosure at
CSU
4. Conflict of Interest Committee contact information
5. Training Review Questions
6. Training Completion Acknowledgement
Tip: If you have questions about this
training, please contact:
 For questions regarding application of the
regulation: [email protected]
 For questions regarding technical difficulties
viewing the training or completing the training
review questions and certificate: ______-
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.
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, 2012. 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
New PHS FCOI Guidelines
(click on the box for more information)
Significant
Financial
Interests
Travel
Subrecipient
Institutions
Public
Accessibility
FCOI
Training
Requirement
Other
Considerations
How to disclose: Fundamental Steps for Disclosure at CSU
Employee fills out Role &Responsibility Survey
Disclosure
R&R Survey
-Annual
-Event based
-Employee Responsibility
-PHS Addendum if
applicable
Update
• Including PHS survey where applicable
Assessment
Management
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
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
Co-Chair, COIC
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:
http://www.provost.colostate.edu/.
A full roster of the COIC is available upon request.
Tip: Handy Reference Guides
PHS investigators may find the following to be helpful laboratory
reference guides:
 NIH FCOI Tutorial:
http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
 Office of Extramural Research FAQs:
http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3374
 CSU COI Website and PHS Addendum Definitions:
http://www.provost.colostate.edu/index.asp?url=Resources/faculty_affairs
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:
[email protected]
Training Review Questions
1. The perception of a FCOI is just as significant as an actual FCOI.
True
False
2. 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 $5000.00.
True
False
3. 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.
True
False
Training Review Questions
1. The perception of a FCOI is just as significant as an actual FCOI.
True
False
2. 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 $5000.00.
True
False
3. 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.
True
False
Training Review Questions
4. Subrecipients must comply with PHS regulations pertaining to FCOI,
including regulations concerning subrecipient reporting obligations.
True
False
5. 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.
True
False
6. The Role & Responsibility Survey is the first step in the disclosure
process.
True
False
References
The COIC would like to offer its thanks to the following institutions for their
resources:
Iowa State: www.compliance.iastate.edu
Columbia University: www.columbia.edu
Office of Extramural Research FAQs:
http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3374
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: [email protected]
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