financial conflict of interest (fcoi) training in public health service funded research colorado...
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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
ResearchThe 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 CSU2. Major Changes in PHS FCOI Guidelines3. How to Disclose: Fundamental Steps for Disclosure at
CSU4. Conflict of Interest Committee contact information5. Training Review Questions6. 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 ImpactThis 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 travelDisclosure of income from certain seminars, lectures, or teaching engagementsPublic accessibility through written response to inquiries related to COIEnforceable policy on financial conflicts of interest that is PHS-compliantMandatory COI training at least every 4 years
New PHS FCOI Guidelines (click on the box for more information)
How to disclose: Fundamental Steps for Disclosure at CSU
Employee fills out Role &Responsibility Survey•Including PHS survey where 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 DeanConflict of Interest Committee-Financial Conflict of Interest*-Conflict of Commitment (time)*-Potential to Compete w/CSU*-Potential adverse impact on students**Real or Perceived
R&R Survey-Annual-Event based-Employee Responsibility-PHS Addendum if applicable
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, COICSenior Assoc VP for Research
Tim Gallagher Co-Chair, COICChair, Faculty Council
Dan Bush Vice Provost for Faculty Affairs
Linda Schutjer Office of General CounselCOI 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.htmOffice of Extramural Research FAQs: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3374CSU 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 Questions1. 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 Questions1. 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]