Financial Conflict of Interest (FCOI) Training in Public Health Service Funded Research

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: http://grants.nih.gov/grants/policy/coi/

3. 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: Marty.Welsch@colostate.edu • 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, 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

7. New PHS FCOI Guidelines (click on the box for more information)

8. How to disclose: Fundamental Steps for Disclosure at CSU • 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: 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.

10. 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: COIC@colostate.edu

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 $5000.00. • True False • 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

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 $5000.00. • True False • 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

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. • True False • 6. The Role & Responsibility Survey is the first step in the disclosure process. • True False

14. 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

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: COIC@colostate.edu