Understanding Conflicts of Interest at the University of Florida, Slides of Law

Download Understanding Conflicts of Interest at the University of Florida and more Slides Law in PDF only on Docsity! Financial Conflict of Interest Docsity.com What is a Conflict of Interest? A conflict of interest in basic terms is described in University policy as a situation in which a person serves or represents two distinct entities (or persons) or must choose between two conflicting interests. A "conflict of interest" in the traditional sense encompasses situations in which a person has actually neglected or breached a duty to one entity to the benefit of another, situations in which a person has used his or her position with one entity to advance personal gain or the gain of another entity, and situations in which there is a potential for breaching a duty to one entity. The latter is sometimes referred to as a "potential" or "apparent" conflict of interest. In this document the term "conflict of interest" will be used to describe all these situations. http://www.generalcounsel.ufl.edu/downloads/COI.pdf Docsity.com 2. All University employees are subject to the conflict interest provisions in the code of ethics of the State of Florida (Chapter 112, Part III, Florida Statutes) and the conflict of interest rules and policies of the University of Florida. Additionally, all investigators involved in research are subject to conflict of interest research regulations including Public Health Service and National Science Foundation projects. 3. The responsibility for adhering to the rules, policies and regulations on conflict of interest and outside activities rests with the individual faculty or staff member. Docsity.com Basic Principles · The educational programs and professional careers of individual students and faculty members cannot be adversely affected by a faculty or staff member's outside activities or financial interests. · The university's research and education programs cannot be adversely affected and must remain credible. The outside activities of employees should not impede the dissemination of knowledge. · The university's personnel and resources must be used for the promotion of the mission of the university and the public interest rather than for private gain. Docsity.com The following outside activities/financial interests provide a basis for a possible conflict of interest: 1) Outside activities which represent time commitments that would interfere with a faculty or staff member's accomplishing his or her university duties. 2) Outside activities using equipment, personnel, or resources of the university. 3) Outside activities where employees and students supervised by the employee are also involved. 4) Outside activities (consulting, employment, management, etc) with a person or entity, or financial interests in an entity, that does business with the university. 5) Outside activities or financial interests in an entity which competes with the University's activities, particularly when these are in the same field as that of the faculty or staff. 6) Outside activities or financial interests in an entity that is supporting the faculty or staff member's research or training activities at the University. Docsity.com Federal Reporting Requirements relating to Sponsored Projects • Federal regulations require that the university manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by certain compensated outside activities and financial interests of persons involved in sponsored research projects funded by the Public Health Service (PHS) and the National Science Foundation (NSF). • The primary purpose of the federal regulations is to prevent bias in the design, conduct, or reporting of research projects. • All investigators and others working on projects funded by the PHS or the NSF must abide by these requirements. • An “investigator” is defined as the principal investigator, co-principal investigator, or any other employee responsible for the design, conduct, or reporting of the proposed or funded research or educational activities. Docsity.com Code of Ethics For State Of Florida Employees • A faculty or staff of the University may not be employed by or have a contractual relationship with a company which is "doing business" with the University. • An exemption is provided which allows a faculty or staff to be a consultant, employed or have an ownership interest in a company that licenses the faculty member's technology from the University. The exemption also allows a faculty member with an employment or contractual relationship with a company to work on a research contract between the university and the company. • However, such relationships are allowed only with the prior review and approval. • This exemption was passed to facilitate transfer of University developed technology to companies by making possible license agreements and research contracts with companies with which the faculty member-inventors have relationships. • The Request for Exemption procedure is done through the Division of Sponsored Research. Docsity.com Institutional Conflict of Interest • An Institutional Conflict of Interest exists when the University holds equity in a company that licenses technology and/or supports ongoing research at the University. • When a research contract is entered into by the University with a company in which the University holds equity, or when a research project is started dealing with a licensed product of a company in which the University holds equity, the Director of Sponsored Research shall inform the department chair, the college, and to the Vice President for Research. The dean of the college, with oversight by the Provost, will be responsible for monitoring the situation, with special attention to resource allocation, employment practices, and graduate student assignments, and for informing the researcher of the policy. • The University can only be involved in clinical trials/product testing of its licensed technology with the approval of the Vice President for Research. Docsity.com New NIH Rule - Process • An investigator discloses a Significant Financial Interest (SFI). • The University reviews the disclosure to decide if the SFI is related to an NIH project and a conflict exists. • Related means when the SFI is affected by the project or SFI is in an entity whose financial interest is affected by the project. • All investigators must receive financial conflict of interest training before engaging in the NIH research and every 2 years thereafter. • The University must develop a monitoring plan to manage the conflict. • The University must post on a website information about financial conflicts in NIH projects including the investigator’s name, their research role, the nature of the SFI, and the dollar value of the SFI. • The university must report on conflicts that are being managed including the value of the financial interest, the nature of the financial interest (equity, consulting fees etc), and key elements of the monitoring plan. Docsity.com Questions • 1. True or False. The simplest way to describe a potential conflict of interest is when a person serves two entities at the same time. • True. And situations where a person has dual loyalties often result in a conflict of interest. In research if an investigator is a paid consultant by the company sponsoring the research bias may exist in the design, conduct or reporting of the research. Docsity.com Questions • 2. As a University of Florida I would have a conflict if a) my private interests interfered with the public interests of the University or if b) my outside activity such as consulting interfered with my ability to fulfill my University responsibilities. • A. a only. • B. b only. • C. a and b. • D. Neither a nor b. • The answer is C. Docsity.com Questions • 5. True or False the following are all situations which could be a conflict. • A. An outside activity on which I spend which a lot of hours and I do not get my UF work done. • B. An outside activity involving a student I supervise at the University. • C. An outside activity with an entity that does business with the University. • D. An outside activity in which I am not being paid. • True. Docsity.com Questions • 6. The following individuals are subject to University, state and federal conflict of interest regulations. • a. Principal Investigator. • b. Co-principal investigator. • c. Any person responsible for the design, conduct or reporting of the research. • A. a only. • B. b only. • C. c only. • C. a, b and c. • D. Neither a, b nor c. • The answer is C. • Docsity.com Questions • 7. Under the Code of Ethics for State of Florida Employees a Request for Conflict Exemption is required when: • a. A person consults for or owns stock in a company and that company sponsors research at the University. • b. A person consults for or owns stock in a company and that company has a license agreement with the University. • c. A person consults for or owns stock in a company. • A. a only. • B. b only. • C. c only. • D. a, b and c. • E. a and b only. • F. Neither a, b nor c. • The answer is D. • Docsity.com