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:

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:  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, 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 Lower Financial Disclosure Thresholds 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 $5,000. Please note that assets in or income from investment vehicles such as mutual funds and retirement accounts are not considered significant financial interests and do not need to be disclosed as long as you do not directly control the investment decisions made in these vehicles. The value of any remuneration received from any non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000, or any equity interest in non-publicly traded entities. Intellectual property rights and interests count toward the $5,000 received from the entity upon receipt of income related to such rights and interests. ( Click on Arrow to Return to New Guidelines)

Travel Increased Transparency for Travel Reimbursement Required: Any reimbursed travel or sponsored travel related to Institutional responsibilities if paid directly on behalf of the Investigator (including purpose of trip, sponsor/organizer, destination, and duration) must be disclosed as a Significant Financial Interest. Not required: Please note that you are not required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. For example, if travel is reimbursed or paid by CSU as part of a gift or sponsored project, it is not considered a significant financial interest and does not need to be disclosed. Tip: Create and maintain a personal log to record all travel that must be reported.. (Click on Arrow to Return to New Guidelines)

Subrecipient Institutions CSU must take reasonable steps to ensure that any subrecipient Investigator complies with the PHS regulations. PHS requires that the: Terms of subrecipient agreements be revised to incorporate this requirement Subrecipients certify that they are in compliance with the regulation Subrecipients disclose all identified financial conflicts of interest to CSU within a specified time period. CSU is also responsible for providing subrecipient FCOI reports to the PHS awarding component PRIOR to expenditure of funds and within 60 days of any subsequently identified FCOI. Tip: The subrecipient response to these requirements will impact the timely start of the agreement. (Click on Arrow to Return to New Guidelines)

Public Accessibility Requirements New Public Accessibility Requirements CSU must make certain information available concerning identified FCOIs. This requirement is limited to FCOI’s held by “senior/key personnel”. PHS defines “senior/key personnel” as the project director or Principal Investigator and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution. At a minimum, CSU must provide the following information: Investigator’s name; Investigator’s title and role on the PHS research project; Name of the entity in which the significant financial interest is held; and Approximate dollar value of the significant financial interest. Tip: Inquiries will be treated like a Colorado Open Records Act (CORA) request. Senior key personnel will be notified by CSU prior to any release of this information. Click on Arrow to Return to New Guidelines

FCOI Training Requirement FCOI Training for all PHS-funded Researchers Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances: Institutional FCOI policies change in a manner that affects Investigator requirements An Investigator is new to an Institution An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan. Click on Arrow to Return to New Guidelines Tip: Investigators are responsible for determining who on the project must be trained in accordance with the PHS regulations and assuring training is completed.

Colorado law prohibits soliciting a personal benefit as an incentive to award a contract or purchase order. 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. Vendors must be selected based on competition, where required, and in all cases based on fair procedures. Pricing must be fair and reasonable regardless of the selection method. “Sole Source” acquisitions are permitted only where there is NO OTHER VENDOR at any price. If you have a conflict relating to a particular vendor, DO NOT participate in the selection process or management of contract if awarded. If you have a conflict relating to a particular vendor, DO NOT share confidential or official information with them. Procurement/Competitive Bid Process

Royalties Royalties are potentially subject to disclosure, as are other interests related to intellectual property. Disclose: Royalties from and agreements to share in royalties related to intellectual property rights paid to an Investigator (or his/her spouse or dependent children) are covered by the regulation if other than from CSU and are subject to the $5,000 threshold. If the royalties paid to the Investigator (or his/her spouse and dependent children) satisfy the definition of “Significant Financial Interest,” then they must be disclosed. Excluded: If the royalties or agreement to share in royalties relate to intellectual property owned by CSU and are licensed or potentially licensed through CSU (i.e., they are not personally owned by the Investigator), they are considered remuneration from the Institution and would not be considered a Significant Financial Interest of the Investigator. Royalties received by the Investigator from CSU would be excluded from the definition of Significant Financial Interest if the Investigator is currently employed or otherwise appointed by the CSU. ---Office of Extramural Research FAQs

Consequences When a FCOI is not identified or managed in a timely manner, including: Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest; Failure by the Institution to review or manage such a Financial Conflict of Interest; or Failure by the Investigator to comply with a Financial Conflict of Interest management plan; the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. If bias is found, the Institution must notify NIH promptly and submit a mitigation report to the NIH. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation. ---Office of Extramural Research FAQs

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 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 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 DelehoyCo-Chair, COIC Senior Assoc VP for Research Tim GallagherCo-Chair, COIC Chair, Faculty Council Dan BushVice Provost for Faculty Affairs Linda SchutjerOffice 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.

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:

Training Review Questions 1. The perception of a FCOI is just as significant as an actual FCOI. TrueFalse 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 $ TrueFalse 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. TrueFalse

Training Review Questions 1. The perception of a FCOI is just as significant as an actual FCOI. TrueFalse 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 $ TrueFalse 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. TrueFalse

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: Columbia University: Office of Extramural Research FAQs:

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: