Conflict of Interest
Summary
Presents and discusses circumstances which can create real or perceived conflicts of commitment and conflicts of interest. Defines key terms. Details substantive prohibitions and restrictions. Describes the procedures for disclosing financial and other interests, reviewing disclosures, reporting information to other agencies, implementing the policy, appealing decisions concerning the policy, and sanctioning non-compliance with the policy. Establishes requirements for ongoing certifications and financial disclosures. Specifies special restrictions on human subjects research.
Purpose of Guidance
This guidance relates to conflicts of interest and conflicts of commitment and applies to all USF Health officers, faculty, staff, students and committee members involved in the academic, clerical or managerial mission of the University ("Health-Affiliated Individuals"). The purpose of this policy is to assist Health-Affiliated Individuals in avoiding both actual and apparent conflicts of commitment or interest between his or her University obligations and his or her private interests. Every Health-Affiliated Individual has an obligation to become familiar with, and abide by, the provisions of this guidance.
Conflicts of interest are common and practically unavoidable in a modern research university. However, Health-Affiliated Individuals should conduct their affairs to avoid or minimize conflicts of commitment or interest, and must respond appropriately when conflicts of commitment or interest arise. The purposes of this policy are to encourage the multiple and diverse interests of Health-Affiliated Individuals while protecting the University's integrity, mission, patients, students and resources. To this end, the objectives of this policy are to educate Health-Affiliated Individuals about situations that generate conflicts of interest, to provide means for the Health-Affiliated Individual and the University to manage conflicts of interest, to promote the best interests of students and others whose work depends on faculty direction, and to describe situations that are prohibited. Institutions and Health-Affiliated Individuals bear a shared responsibility for the oversight of financial interests in research, yet each remains accountable for the effectiveness of the oversight system.
In addition, federal regulations require institutions to have policies and procedures that ensure that Investigators disclose any significant financial interests that may present an actual or potential conflict of interest in relationship to sponsored research projects. Such disclosure must be made prior to the submission of a proposal for funding or at the time a potential conflict develops.
It is the responsibility of each Health-Affiliated Individual to report identified conflicts of interest, regardless of the magnitude, appropriateness, time or location of the activity. All financial interests must be reported, whether or not the financial interest reaches the "significant financial interest" threshold defined in this policy, or any other threshold established by state or federal law.
General Principals
Reporting and Review of Conflicts of Commitment and Conflicts of Interest
Requirement for Reporting Conflicts of Interest in Research
Requirements for Reporting of Outside Activity
Definitions (Appendix A)
- Compensation means any salary; honorarium; benefits; services; fees; milestone payments; bonuses; equity interests and royalties; proprietary interests; warrants; grant funding; corporate underwriting; patent, trademark, copyright or license agreements commissions; payments; gifts; real property; the use of real property; tangible or intangible personal property; the use of tangible or intangible personal property; preferential rates or terms on a debt, loan, goods or services; or anything of value.
- Conducting Research means, with respect to a research protocol, designing research, directing research, or serving as the principal investigator, co-investigator or investigator, enrolling research subjects (including obtaining subjects' informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication.
- Conflict of Commitment means a conflict of interest with University employment that primarily relates to issues of time allocation.
- Conflict of Interest is any conflict between the private interests of the employee and the public interests of the University, the University Board of Trustees, The Florida Board of Education or the State of Florida, including conflicts of interest specified under Florida Statutes OR any activity that interferes with the full performance of the employee's professional or instructional responsibilities or obligations.
- Conflict of Interest in Research refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an Investigator's professional judgment in the conduct, evaluation or reporting of research.
- Consulting means professional activity related to the person's field or discipline, where a fee-for-service or equivalent relationship with a third party exists.
- Designated University Official (herein referred to a "Official") is the responsible administrative official with immediate supervisory authority over the employee. Normally, the Official will be the department chair. For administrative units in which there are no departments, or if the employee is a department chair, the Official will be the unit Director or Dean. For Directors and Deans, the Provost or other appropriate Vice President will serve as the Official.
- Disclosure means a release of relevant information about significant financial interests in human subjects research to parties outside the institution's COI review and management processes (e.g. to research subjects or journal editors).
- Financial Interest means any compensation which is accepted by the employee or that which is paid or given to the employee directly, indirectly, or in trust by any other means.
- Financially Interested Individual means an individual who holds a significant financial interest that would reasonably appear to be affected by the individual's human subject research.
- Health-Affiliated Individual means USF Health officers, faculty, staff, students and committee members involved in the academic, clerical or managerial mission of the University.
- Human Subjects Research includes all research meeting the definition of "research" performed with "human subjects" as these terms are defined in the federal Common Rule (45 C.F.R. Part 46 and 21 C.F.R. Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation. In the event that the Common Rule definitions of "human subjects" or "research" are modified through rulemaking, any such revisions shall apply for the purposes of this guidance.
- Institutional Conflict of Interest may occur whenever the financial interests of the institution, or of an institutional official acting within his or authority on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the conduct, review, or oversight of research, especially human subjects research.
- Investigator means the principal investigator, co-investigator or any other person who is responsible for the design, conduct, evaluation, patient care, and/or reporting of research for the proposed or ongoing project. For the purposes of the requirements of the subpart relating to financial interests, "Investigator" includes the Investigator's relatives and trusts or any other financial vehicle designed to obfuscate ownership.
- Outside Activity shall mean any private practice, private consulting, or other activity, compensated or uncompensated, which is not part of the employee's University duties and for which the University has provided no compensation.
- Rebuttable Presumption Against Financial Interests in Human Subjects Research means the institution will presume, in order to assure that all potentially problematic circumstances are reviewed, that a financially interested individual may not conduct the human subjects research in question. This rule is not intended to be absolute: a financially interested individual may rebut the presumption by demonstrating facts that, in the opinion of the COI committee, constitute compelling circumstances. The individual would then be allowed to conduct the research under conditions specified by the COI committee and approved by the responsible IRB.
- Relative or Related Persons are those related to each other in one of the following ways: husband, wife; parent; child; brother; sister; spouse of a child, brother or sister or parent, child, brother or sister of a spouse.
- Reporting means the provision of information about significant financial interests in human subjects research by a covered individual to responsible institutional officials and to the institutional COI committee, or the transmission of such information within institutional channels (e.g., from the COI committee to the IRB).
- Responsible Institutional Official means a Dean, Provost, CEO, or other institutional official who is responsible for the oversight of conflicts of interest within the institution.
- Responsible IRB is the institutional review board (or boards) with jurisdiction over the research as specified in the multiple projects assurance (MPA) (or the federal-wide assurance (FWA)) that the institution has provided the U.S. Department of Health and Human Services, or as otherwise established under DHHS or DA regulation or policy.
- Significant Financial Interests means
- Income including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, or any other payments or considerations from a single business entity or their nonprofit affiliate entity exceeding $10,000 per annum or $50,000 over the course of the study and one year thereafter when aggregated for the Investigator. (The amounts stated are based on current FDA rules and may be amended from time to time.)
- Equity in the form of stock, stock options, real estate, or any other investment of ownership representing more than 5% interest for any one entity when aggregated for the Investigator. (The percentages stated are based on current FDA rules and may be amended from time to time.)
- A Position as director, officer, partner, trustee, or member of board of directors of any business entity.
- An interest in Intellectual property in which the property is held by a party other than the University.
Related University and USF Health Policies
USF Policies on the General Counsel's Home Pages | |
---|---|
University Copyright Policy | 0-105 |
Candidacy of Employees for Public Office | 0-012 |
Use of University Name and Symbols | 0-215 |
Conflicts of Interest in Sponsored Research | 0-309 |
Statement of Policy Regarding Inventions and Works | 0-300 |
Misconduct in Research | 0-301 |
Research and Research Grants | 0-304 |
Use of University Space (All-Inclusive) | 0-505 |
Appropriate Use of Information Technology Resources | 0-502 |
USF Faculty Rule, Faculty Ethical Obligations: Conflicts of Interest and Outside Employment; Employment of Relatives; Seeking or Holding Public Office | 10.107 |
Federal Authority
FDA Regulations, "Financial Disclosure By Clinical Investigators" (21 CFR Part 54) (April 1, 2002) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=54
PHS Regulations, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought" (42 CFR Part 50, 50.601-50.607) (July 11, 1995) http://grants1.nih.gov/grants/guide/notice-files/not95-179.html
NSF Policy on Conflict of Interest (NSF Grants Policy Manual, Section 510) http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510
State Authority
Florida Statutes, Section 112.313, "Standards of Conduct for Public Officers and Employees of Agencies" (2001) Refer to the Florida Statutes and click on Title X, Chapter 112, Part III, Section 112.313.
Other References
FDA Guidance For Industry, "Financial Disclosure By Clinical Investigators" (March 20, 2001) http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm341008.pdf
AAU Report on Individual and Institutional Conflict of Interest (October 9, 2001) http://www.aau.edu/policy/COI_reports.aspx?id=10094
NIH Guide, "Objectivity in Research" (July 14, 1995) http://grants1.nih.gov/grants/guide/notice-files/not95-179.html
NIH Guide, "Financial Conflict of Interest and Research Objectivity; Issues for Investigators and Institutional Review Boards" (June 5, 2002) http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html