展昭艳谈

The University Conflict of Interest (COI) policy contains a description of what is a COI under the Code of Ethics, which is set forth in the Florida Statutes. The policy discusses how to obtain a COI exemption from the Code for Research and license agreements.

The policy also describes the Public Health Service (PHS) and National Science Foundation (NSF) regulations concerning research and COI compliance requirements.

• List of organizations that require compliance with PHS regulations
• National Institutes of Health (NIH) FCOI Guide
• UF Guidelines, Policies, and Procedures on Conflict of Interest and Outside Activities, including Financial Interest

COI records are to be retained 3 years from completion of the research that pertains to the project with the conflict or 3 years from the end of the license agreement that is the subject of the conflict.

The Public Health Service (PHS) published a new Financial Conflict of Interest (FCOI) Regulation which takes effect on August 24, 2012. One component of the regulation is that the University post on a public web page information concerning investigators on a PHS funded project who have a FCOI. The required information is listed below. The information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the University identification of a new FCOI.

University of Florida employees and scientists may collaborate with companies to help develop scientific and medical breakthroughs or to provide expertise. As leaders in their fields, UF scientists are often sought after by companies. To assure professional and commercial integrity in such matters, UF reviews these collaborations and, when appropriate, puts measures in place to minimize bias that may result from ties to companies.

Investigator Name and Date	Title and Role in Research	Entity Name	Nature Of Interest	Approximate Dollar Value
William Hauswirth 8/24/2012	Principal Investigator	Applied Genetic Technologies Corporation	Stock and Consulting Fee	$30,000 Stock/ $40,000 Consulting Fee
Nicholas Muzyczka 8/24/2012	Principal Investigator	Applied Genetic Technologies Corporation	Stock	$33,333
Paul Okunieff 8/24/2012	Principal Investigator	DiaCarta	Stock	$20,000
Roger Fillingim 8/24/2012	Principal Investigator	Algynomics	Stock	$40,000
David Reisman 8/24/2012	Principal Investigator	Zenagene	Stock	The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Hendrik Luesch 8/24/2012	Principal Investigator	Oceanyx Pharmaceuticals	Stock	$500
Roy Curtiss 3/15/16	Principal Investigator	Curtiss Healthcare	Stock, Chief Science Officer and Founder	$350
Paul Okunieff 4/4/2017	Principal Investigator	GainPep, Inc.	Stock, consulting and member of the Board of Directors	$0 – 4999 Stock/ $0 – 4999 Consulting Fee
Todd Brusko 5/30/2017	Principal Investigator	OneVax, LLC	Stock, Chief Science Officer	<$50,000 Stock/ $1500 annually
Coy Heldermon	Principal Investigator	Lacerta Therapeutics, Inc.	Stock, Member of the Board of Directors/Scientific Advisory Board Member td>	The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Sergei Zolotuhkin	Co-Investigator	Lacerta Therapeutics, Inc.	Stock, Co-Founder/Member of the Board	The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Ronald Mandel	Co-Investigator	Lacerta Therapeutics, Inc.	Stock	The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Maurice Swanson	Principal Investigator	Locana, BIO	Scientific Advisory Board Member	The interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value

1. The Public Health Service (PHS) Conflict of Interest (COI) regulation requires Principal Investigators and all Key Personnel in PHS-funded projects to complete the Financial Conflict of Interest (FCOI) training before engaging in the research.
   1. UF has established a specific FCOI training course DSR 810, which satisfies this PHS requirement.
   2. This course can be accessed through myUFL > My Self Service > Training and Development > MyTraining.
2. Education is required of each individual initially and then every four years
3. Education is required immediately when:
   1. Financial conflict of interest policies are revised in a manner that changes researcher requirements
   2. A researcher is new to the organization
   3. A researcher is non-compliant with financial conflict of interest policies and procedures
4. Persons involved in non-PHS funded projects can get general information about FCOI by accessing the following:

• Financial Conflict of Interest (PowerPoint)
• Financial Conflict of Interest (PDF)

Every Public Health Service (PHS) and National Science Foundation (NSF) grant application submitted to Division of Sponsored Programs (DSP) requires completed PHS and NSF Disclosure of Significant Financial Interest (SFI) forms. These forms are for internal review only, and they are not submitted to the sponsor.

• PHS Significant Financial Interest Disclosure Form (PDF): Required when UF will be the recipient or a sub-recipient of funding from a US Public Health Service Organization (HHS, PHS, NIH, HRSA, FDA, SAMSA, AHRQ, CDC, CMS). This form is also used with non-federal sponsors that adopt the PHS FCOI policy, for example, American Heart, FDOH/Bankhead Coley, Alliance for Lupus Research (ALR), American Cancer Society (ACS), American Heart Association (AHA), Arthritis Foundation (AF), Juvenile Diabetes Research Foundation (JDRF), Lupus Foundation of America (LFA), and Susan G. Komen for the Cure American Lung Association.
• NSF Significant Financial Interest Disclosure Form (PDF): Required when UF will be the recipient or a sub-recipient of funding from the National Science Foundation (NSF).

• USAMRMC or CDMRP Financial Interest Disclosure Form (PDF): The Congressionally Directed Medical Research Programs (CDMRP) and the United States Army Medical Research and Materiel Command (USAMRMC) is required with each grant application where UF will be the recipient or a sub-recipient of funding from the United States Army Medical Research and Materiel Command (USAMRMA) or from the Congressionally Directed Medical Research Program (CDMRP).
• Request for Exemption Form
• Monitoring Plan Form
• Exhibit A Form
• Entity Sponsored COI Workflow for CoM Researchers
• Federally Sponsored COI Workflow for CoM Researchers

What do I do if I think I may have a research conflict?

• Contact the Division of Research Operations & Services at (352) 392-1587 or email coi@research.ufl.edu.

Note the University’s Conflict of Interest and Outside Activities Policy provides the forms required for conflict approval. For non-research conflicts, contact your college.

Why does the university care about conflicts and outside activities?

Faculty and staff must recognize their main responsibility is to the University. They may engage in outside employment, consulting, and similar activities that spread knowledge and expertise developed at the University and advance the professional competence of faculty and staff.

Thus, participating in outside activities often both serve the University’s mission and benefit employees. However, if such activities and financial interests conflict with an employee’s University duties, then they can become a concern.

University policy allows faculty and staff to participate in outside activities and hold financial interests as long as they do not conflict with their duties.

What are the regulatory agencies responsible?

University employees are subject to the Code of Ethics, which is set forth in the Florida Statutes. The Code of Ethics restricts activities of University employees, including when an employee has a relationship with a company that is doing business with the University.

University employees, who are investigators on Public Health Services (PHS and those agencies adopting PHS) and National Science Foundation (NSF) federal projects, are subject to the PHS and NSF COI regulations.

What’s the difference between a Florida and federal conflict, and what are exemptions?

Florida statutes do not allow a University employee to have a contractual, employment or financial relationship with a company that is doing business with the University.

An Exemption, which allows an employee to have such a relationship, is provided for the following:

• When the company licenses the employee’s technology from the University, or when an employee is an investigator on a research contract between the University and the company.

However, such Exemptions are allowed only with prior review and approval. The Exemption procedure is done through the Division of Research Compliance and the appropriate college.

Federal regulations require the University to manage, reduce, or eliminate any Financial Conflict of Interest (FCOI) involving certain compensated outside activities and financial interests of persons involved in research projects funded by the Public Health Service (PHS), the American Heart Association (AHA), the National Science Foundation (NSF) and organizations that adopt the PHS regulations.

The University’s Conflict of Interest and Outside Activities Policy contains a detailed description of what is considered a conflict under both the Florida statute and Federal regulations. The Researcher’s Handbook also provides helpful information concerning conflicts of interest.

What is a supervisory conflict?

A University employee or student cannot have a relationship with a company if their supervisor also has a relationship with the same company. However, an exception may be allowed if the University student or employee is a co-inventor or co-contributor to the intellectual property.

What is the university policy on conflicts and human subjects research?

The University will take particular care with respect to management of any potential institutional conflicts of interest in research involving human subjects so as to protect the welfare of human subjects and the integrity of the research. In order for the University or any of its employees to participate in a human subjects research project that represents an institutional conflict of interest as described in this policy, the project must be reviewed and approved by the University’s Vice President for Research and an appropriate conflict management plan must be approved. Factors that will determine the suitability of the University’s participation in the proposed human subject research project and management plan include the following:

• The degree of risk to human subjects inherent in the research.

• The ability of the University to appropriately safeguard the welfare of the human research participants

• The nature of the institutional and additional individual conflicts of interest and the degree to which the conflict(s) can be effectively managed.

• Whether the University is uniquely qualified, by virtue of distinctive resources (e.g. special facilities or equipment that cannot be duplicated easily, unique patient population) and/or the unique experience and expertise of its investigators, to conduct the research and appropriately safeguard the welfare of the human research participants involved.

• The number of trial centers, the clinical trial phase and role of the University in the case of human subject clinical trials.

Can a conflicted person be involved in a subcontract to their company?

If a person has a relationship with a company and is a research investigator for the University, then significant conflict issues exist. The person would have to justify why there needed to be a subcontract to their company. Some conflict issues that arise are confidentiality of information, bias and intellectual property issues.

What is a conflict management plan, and why is it needed?

Conflicts of interest are common in research, especially in light of the increased support of University-industry collaboration. Conflicts of interest are not inherently bad and can exist as long as they protect the integrity of the research.

A management plan establishes conditions needed to ensure the design, conduct or reporting of research that is not directly and significantly affected by any investigator’s financial conflict of interest. The management plan also protects students and postdoctoral fellows from inappropriate pressures and protects intellectual property rights.

What are possible management plan conditions?

• Disclosing financial interests to other investigators, students, human subjects and in publications;
• Training on conflicts of interest and commitment for all personnel involved in the research;
• Restrictions on using UF resources and personnel;
• Protecting intellectual property and confidential information
• Modifying the research plan;
• Having a company person negotiate and sign agreements with UF;
• Disqualifying participation in all or a portion of the research;
• Divestiture of significant financial interests; and/or
• Severing relationships that create actual or potential conflicts.

What happens if I do not comply with UF’s Conflict of Interest Policy?

Non-compliance is addressed under applicable policies.

Research study review will be delayed when there is a failure to file a Research-Related Financial Interest Disclosure form by any investigators responsible for the design, conduct or reporting of PHS and NSF projects. Such proposals will not be submitted until all investigators have completed disclosure forms.

Also, award funds will not be released until all investigators with a conflict have that conflict approved.