- Research Compliance
A conflict of interest (COI) occurs when a person serves or represents two distinct entities or persons and must choose between two conflicting interests or loyalties.
A University employee has a conflict when his/her outside activity or financial interest could potentially interfere with their professional obligations to the University.
Outside activities, include but are not limited to:
Such activities should be reported and approved by the University before beginning the activity. All financial interests, including but not limited to, stock, cash and LLC. interests in an entity that does business with the University should also be reported and approved by the University.
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.
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|
|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|
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.
What do I do if I think I may have a research conflict?
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:
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:
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?
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.