Which of the following statements is true regarding the reporting of outside interests

1/26/2019CITI Training Flashcards | QuizletAn investigator received$4,000 of consultingincome from a publiclytraded drug companyover the past 12 months.The investigator alsoowns stock in thatcompany valued at$2,000. The investigatoris submitting a grant tothe National Institutesof Health that involvesevaluating theeffectiveness of a drugproduced by the samedrug company. Whichof the following is true?The aggregate of the consulting income and the stockexceeds $5,000 and therefore is a significant financialinterest.Which of the followingis true regarding the

Get answer to your question and much more

U.S. Public HealthService and itsapproach to thedisclosure of significantfinancial interests?Which of the followingstatements is trueregarding the reportingof outside interests andthe management ofconflicts?Health Service to do

Get answer to your question and much more

which of the following:Which of the followingstatements mostA report to the U.S. Public Health Service of efforts thatwill be taken by the institution to deal with any bias that

Conflicts of Interest

• CAMS Training (Conflict of Interest Management System)
• Federal Financial Conflict of Interest Disclosures
• Outside Activities/Conflict of Interest
• Outside Activities/Conflict of Commitment
• Guidelines for Faculty Start-ups and Conflicts of Interests
• Conflict of Interest in Procurement
• Other Conflict of Interest Issues Related to the Uniform Guidance
• Conflicts of Interest and Intellectual Property
• Conflict of Interest Monitoring and Reporting
• Other Useful Links Related to Conflicts of Interest and Ethics
• Forms
• COI Brochure

Federal Financial Conflict of Interest Disclosures

FSU Policy 7A-21, Financial Conflict of Interest Disclosure

Certain funding agencies have implemented regulations promoting objectivity in research by requiring that a university applying for extramural research funding ensure that there is no reasonable expectation that the design, conduct, and reporting of the research to be funded pursuant to the application will be biased by any significant financial interest of any Investigator working on the research. The University has created Policy 7A-21, Financial Conflict of Interest Disclosure to prevent or resolve, through management and/or mitigation, real or apparent conflicts that may exist in relation to research, instruction, and service activities undertaken by University investigators.

If you do not see a disclosure procedure applicable to the agency to whom you are submitting a proposal or from whom you have received an award, please contact Diana Key in the Office of Research Compliance Programs for assistance.

FSU Financial Conflicts of Interest Disclosure - Quick Reference Guide

PHS Research Related Links

FSU Procedures for Financial Interest Disclosures for PHS
FSU Flowchart for PHS Significant Financial Interest Disclosure Process
FSU Electronic Disclosure Management System (EDMS)
PHS Conflict of Interest Regulations, 42 CFR Part 50, Subpart F

NSF Research Related Links

FSU Procedures for Financial Interest Disclosures for NSF
FSU Significant Financial Interest Disclosure Form for NSF
FSU Flowchart for NSF Significant Financial Interest Disclosure Process
NSF Conflict of Interest Regulations, NSF Proposal and Award Policy and Procedures Guide, Chapter IV.A

EPA Research Related Links

FSU Procedures for Financial Interest Disclosures for EPA
FSU Conflict of Interest Disclosure Form for EPA
Subrecipient Conflict of Interest Disclosure for EPA
EPA’s Final Financial Assistance Conflict of Interest Policy

For assistance with Federal Financial Conflicts of Interest issues, please contact Diana Key, Director, Research Compliance Programs at (850) 644-8648 or . For EDMS technical assistance, please contact Julie Haltiwanger at or 644-7900.

Outside Activities/Conflict of Interest

In addition to Federal financial conflict of interest disclosure regulations, Florida State University and the State of Florida have established regulations prohibiting conflicts of interest.

FSU Faculty Handbook

Outside Activities/Conflict of Interest, excerpt from the FSU Faculty Handbook.

State of Florida Statute

F.S. 112.313, Standards of conduct for public officers, employees of agencies, and local government attorneys

This statute outlines a variety of standards that university employees are to uphold.  The following are two examples of the standards identified in the statute which are of particular interest to FSU researchers:

Doing Business With One’s Agency [Subsection (3)]
—No employee of an agency acting in his or her official capacity as a purchasing agent, or public officer acting in his or her official capacity, shall either directly or indirectly purchase, rent, or lease any realty, goods, or services for his or her own agency from any business entity of which the officer or employee or the officer’s or employee’s spouse or child is an officer, partner, director, or proprietor or in which such officer or employee or the officer’s or employee’s spouse or child, or any combination of them, has a material interest. Nor shall a public officer or employee, acting in a private capacity, rent, lease, or sell any realty, goods, or services to the officer’s or employee’s own agency, if he or she is a state officer or employee, or to any political subdivision or any agency thereof, if he or she is serving as an officer or employee of that political subdivision. The foregoing shall not apply to district offices maintained by legislators when such offices are located in the legislator’s place of business or when such offices are on property wholly or partially owned by the legislator. This subsection shall not affect or be construed to prohibit contracts entered into prior to:
(a) October 1, 1975.
(b) Qualification for elective office.
(c) Appointment to public office.
(d) Beginning public employment.

Conflicting Employment or Contractual Relationship [Subsection (7)]
(a) No public officer or employee of an agency shall have or hold any employment or contractual relationship with any business entity or any agency which is subject to the regulation of, or is doing business with, an agency of which he or she is an officer or employee, excluding those organizations and their officers who, when acting in their official capacity, enter into or negotiate a collective bargaining contract with the state or any municipality, county, or other political subdivision of the state; nor shall an officer or employee of an agency have or hold any employment or contractual relationship that will create a continuing or frequently recurring conflict between his or her private interests and the performance of his or her public duties or that would impede the full and faithful discharge of his or her public duties.
1. When the agency referred to is that certain kind of special tax district created by general or special law and is limited specifically to constructing, maintaining, managing, and financing improvements in the land area over which the agency has jurisdiction, or when the agency has been organized pursuant to chapter 298, then employment with, or entering into a contractual relationship with, such business entity by a public officer or employee of such agency shall not be prohibited by this subsection or be deemed a conflict per se. However, conduct by such officer or employee that is prohibited by, or otherwise frustrates the intent of, this section shall be deemed a conflict of interest in violation of the standards of conduct set forth by this section.
2. When the agency referred to is a legislative body and the regulatory power over the business entity resides in another agency, or when the regulatory power which the legislative body exercises over the business entity or agency is strictly through the enactment of laws or ordinances, then employment or a contractual relationship with such business entity by a public officer or employee of a legislative body shall not be prohibited by this subsection or be deemed a conflict.
(b) This subsection shall not prohibit a public officer or employee from practicing in a particular profession or occupation when such practice by persons holding such public office or employment is required or permitted by law or ordinance.

Exemption Pursuant to Section 112.313(12)(h), Florida Statutes

F.S. 112.313(12)(h), states that “…no person shall be held in violation of subsection (3) or subsection (7) if…the transaction is made pursuant to s. 1004.22 or s. 1004.23 and is specifically approved by the president and the chair of the university board of trustees. The chair of the university board of trustees shall submit to the Governor and the Legislature by March 1 of each year a report of the transactions approved pursuant to this paragraph during the preceding year.”

Requesting an Exemption from State of Florida COI Statute

To request an exemption for a research-related activity, complete the Request for Exemption from Conflict of Interest Laws form and submit it to:

Diana Key, Director
Office Research Compliance Programs (ORCP)
FSU Office of Research
2021 Westcott North
Tallahassee, FL 32306-1330

Signed and scanned forms may also be submitted via email to Diana Key at . Before an exemption can be approved, the individual may also be asked to provide copies of any of the following:

• Faculty Outside Activity Statement
• A&P/USPS/OPS Statement Concerning Outside Employment
• Agreements (contracts, grants, non-disclosure, material transfer, etc.), with scope of work as applicable.
• Draft conflict of interest monitoring plan (for review prior to obtaining signatures), as appropriate. Click here for the Monitoring Plan Template.

For assistance with Outside Activities/Conflict of Interest issues related to FSU research, please contact Diana Key, Director, Research Compliance Programs at (850) 644-8648 or . For questions not related to FSU research, please contact the Office of Faculty Development and Advancement at (850) 644-6876.

Outside Activities/Conflict of Commitment

Florida Statutes, Part III, Chapter 112, provide that no faculty or staff member shall engage in any outside activity that interferes with the full performance of his or her assigned duties. They further provide that such activities shall not create a conflict of interest, which is defined in Chapter 112.312 to mean a situation in which regard for a private interest tends to lead to disregard of a public duty or interest. The responsibility for complying with these provisions of Florida law is placed upon the faculty or staff member.

Interference with Performance of Assigned Duties

The determination of whether or not and to what allowable extent a given outside activity of a faculty member interferes with the performance of assigned duties is the responsibility of the person's department chairman or appropriate supervisor, who is expected to apply sound professional judgment based upon standard practice in the particular field or discipline. This determination is made pursuant to the following general provisions of Florida law and University Policy:
1. No employee shall solicit or accept anything of value that would be influential to the performance of assigned duties or that is based upon an understanding that the official action or judgment of the employee would thereby be influenced. (Chapter 112.313(2), F.S.)
2. No employee shall have an employment or contractual relationship that will create a continuing or frequently recurring conflict between that employee's private interests and the performance of assigned duties. However this shall not prohibit an employee from having an occupation when that occupation by a person holding such public employment is required by law. (Chapter 112.313(7), F.S.)
3. In determining the allowable extent to which a teaching faculty member's classroom teaching assignment may be modified by rearranging schedules or providing substitute instructors to accommodate approved outside activities, the approving authority shall take into account not only the standard practice in the field or discipline but also the extent to which the outside activity benefits the program, the institution, and the faculty member as discussed in Section I above.
4. Any outside activity that involves both an employee and the employee's supervisor in a relationship, such as business relationships, which affects the ability of the supervisor to perform normal supervisory duties relative to that employee is prohibited.

Guidelines for Faculty Start-ups and Conflicts of Interest

Conflicts of interest (COIs) are inherent in collaborations between the university and companies in which an investigator has Significant Financial Interests (SFIs). Detailed guidelines for navigating COI issues when faculty start-up companies engage in University research can be viewed here.

Conflict of Interest in Procurement

Excerpts from 2 CFR 200: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (aka, Uniform Guidance):

§ 200.112 Conflict of interest
The Federal awarding agency must establish conflict of interest policies for Federal awards. The non-Federal entity must disclose in writing any potential conflict of interest to the Federal awarding agency or pass-through entity in accordance with applicable Federal awarding agency policy.

§ 200.318(c)(1) General procurement standards
The non-Federal entity must maintain written standards of conduct covering conflicts of interest and governing the actions of its employees engaged in the selection, award and administration of contracts. No employee, officer, or agent may participate in the selection, award, or administration of a contract supported by a Federal award if he or she has a real or apparent conflict of interest. Such a conflict of interest would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization which employs or is about to employ any of the parties  indicated herein, has a financial or other interest in or a tangible personal benefit from a firm considered for a contract. The officers, employees, and agents of the non-Federal entity may neither solicit nor accept gratuities, favors, or anything of monetary value from contractors or parties to subcontracts. However, non-Federal entities may set standards for situations in which the financial interest is not substantial or the gift is an unsolicited item of nominal value. The standards of conduct must provide for disciplinary actions to be applied for violations of such standards by officers, employees, or agents of the non-Federal entity.

All Federal agencies are required to establish conflict of interest regulations in accordance with 2 CFR 200.112. FSU faculty and staff are strongly advised to consult the applicable agency regulations before attempting a procurement transaction related to a Federal award where an actual or perceived conflict of interest may exist.

FSU Procurement Policy

Excerpt from Policy 4-OP-A-6 PROCUREMENT OF COMMODITIES AND CONTRACTUAL SERVICES, Paragraph F; 

https://policies.vpfa.fsu.edu/policies-and-procedures/business-operations/procurement-services#Conflict

“All individuals shall act in accordance with the standards of professional ethics set forth in university policies and procedures, including those outlined below. Section 112.313, Florida Statutes, places restrictions on University employees who, acting in a private capacity, attempt to rent, lease or sell any realty, commodities or contractual services to their own agency. At all times it is the responsibility of the faculty or staff member to know and abide by the State's Conflict of Interest laws. The burden of violating the State's Conflict of Interest laws never shifts to the University [emphasis added]. It also places restrictions on an employee who has a contractual relationship or who holds a material interest in a business entity, which is doing business with any agency which he or she is an employee.”

In order to do business with FSU, the supplier must fill out a Supplier Substitute W-9 form and certify that there is no conflict of interest: 

"At the present time, to the best of your knowledge, is any member of your company an employee of FSU or on the FSU payroll?   Yes    No"

FSU’s standard solicitation document contains the following language in which vendors certify by signing a Competitive Solicitation Acknowledgement Form with the solicitation document.

 “Conflict of Interest:  The award hereunder is subject to the provisions of Chapter 112, F.S. Vendors must disclose with the proposal the name of any officer, director, or agent who is also an employee of FSU. Further, all vendors must disclose the name of any FSU employee who owns, directly or indirectly, an interest of five percent (5%) or more in the Successful firm or any of its branches.”

FSU requires all members serving on an Invitation to Negotiate (ITN) evaluation and negotiation committee to read and submit a Committee Member Certification Form which states:

“I certify that I have no conflict of interest with regard to the outcome of this Competitive Solicitation, either directly or indirectly, and that if I am uncertain whether or not a situation or circumstance might constitute a conflict of interest or an ethics violation, I must immediately disclose this information to the individual listed as the Sole Point of Contact for this Competitive Solicitation.

I further certify that my evaluation of all proposals will be made based on the criteria outlined in the Competitive Solicitation document, that I have had no contact with any potential participants with regard to this Competitive Solicitation that could be viewed as a conflict of interest either before, during, or after the issuance of this Competitive Solicitation, and that I have fully apprised myself of this criteria prior to assigning preliminary or final scores.

I understand that the ethics laws of the State of Florida apply to me, whether or not I am an employee of The Florida State University. My evaluation of all responses will be made based on the criteria outlined in the Competitive Solicitation document and I have fully apprised myself of these criteria prior to assigning preliminary or final scores.

If I perceive a potential conflict of interest exists that could not be determined in advance, but arises only after proposals have been received from participating firms or entities, I will notify the person listed as the Sole Point of Contact so that I may be replaced on the evaluation committee, if necessary.”

Prior to processing a procurement transaction related to a Federal award where an actual or perceived conflict of interest is disclosed, please contact Diana Key, Director, Research Compliance Programs at (850) 644-8648 or .

Other Conflict of Interest Issues Related to the Uniform Guidance

U.S. Department of Education (DOED)

As part of its implementation of 2 CFR 200, DOED adopted 200.318 for procurement under a Federal award, but also established the clause 34 CFR 75.252, Conflict of Interest: Participation in a Project for non-procurement:

75.525   Conflict of interest: Participation in a project.
(a) A grantee may not permit a person to participate in an administrative decision regarding a project if:
(1) The decision is likely to benefit that person or a member of his or her immediate family; and
(2) The person:
(i) Is a public official; or
(ii) Has a family or business relationship with the grantee.
(b) A grantee may not permit any person participating in the project to use his or her position for a purpose that is—or gives the appearance of being—motivated by a desire for a private financial gain for that person or for others.

If an FSU employee has a conflict as described by DOED above, prior to submitting the proposal, the Principal Investigator must contact ORCP to discuss how to mitigate or eliminate the conflict.

Other Agency Implementations

This website will be updated as needed if and when any other agency implements a conflict of interest regulation which deviates from the basic Uniform Guidance clauses.

For assistance with conflict of interest issues related to the Uniform Guidance, Agency implementations, or any Federal regulation, please contact Diana Key, Director, Research Compliance Programs at (850) 644-8648 or .

Conflicts of Interest and Intellectual Property

FSU’s Office of Commercialization is available to work with faculty on any intellectual property issue, including knowing when to refer researchers to ORCP on activities involving conflicts of interest. Please contact the Office of Commercialization at (850) 644-8637 or visit their website to get started.

Conflict of Interest Monitoring and Reporting

FSU shall take appropriate action to manage financial conflicts of interest, including any financial conflicts of interest of a subrecipient. Management of an identified financial conflict of interest requires development and implementation of a monitoring plan. In addition, monitoring plans require annual reviews to be submitted.

Monitoring Plan for Potential Conflicts of Interest

Monitoring Plan Review Checklist (Annual Report)

Other Useful Links Related to Conflicts of Interest and Ethics

• HHS Office of Research Integrity Conflict of Interest Tutorial 

• Florida Commission on Ethics

• State of Florida, Code of Ethics for Public Officers and Employees (F.S. 112.311-112.326)

• Conflict of Interest Issues, Examples and Solutions, links to FSU’s Office of Commercialization

• Conflicts of Interest, links to FSU’s Graduate School

• Conflict of Interest & Ethics, links to FSU Policy 4-OP-A-6, Procurement of Commodities and Contractual Services, Paragraph II.F.

Forms

FSU Significant Financial Interest Disclosure Form for NSF

Faculty Outside Activity Statement 2017-2018

Request for Exemption from Conflict of Interest Laws

Conflict of Interest Management Plan

Management Plan Annual Report

Which of following is true about the management of conflicts of interest?

Which of the following is true regarding the US Public Health Service and its approach to the disclosure of significant financial interests?

What is the value amount threshold for disclosing an outside activity or interest?

Which of the following is true regarding the US Public Health Service and its approach to the disclosure of significant?