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.

Related University and USF Health Policies:

http://www.usf.edu/usfgc/gc_pp/gctblcnt.htm (USF Policies on the General Counsel's Home Pages)

University Copyright Policy (New 4/20/2000)	0-105
Candidacy of Employees for Public Office (Rev 6/3/99)	0-012
Use of University Name and Symbols	0-215
Conflicts of Interest in Sponsored Research (Rev. 2/11/05)	0-309
Statement of Policy Regarding Inventions and Works (Rev. 4/20/00)	0-300
Misconduct in Research (Rev. 5/21/91)	0-301
Research and Research Grants (Rev. 5/9/00)	0-304
Use of University Space (All-Inclusive) (Rev. 6/28/91)	0-505
Appropriate Use of Information Technology Resources (Rev. 2/23/95)	0-502
USF Faculty Rule, Faculty Ethical Obligations: Conflicts of Interest and Outside Employment; Employment of Relatives; Seeking or Holding Public Office	6C4-10.107

Federal Authority:

FDA Regulations, "Financial Disclosure By Clinical Investigators" (21 CFR Part 54) (April 1, 2002)

PHS Regulations, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought" (42 CFR §50)

NIH Guide—Objectivity in Research (July 14, 1995)

NSF Policy on Conflict of Interest (NSF Grants Policy Manual, Section 510)

State Authority:

Florida Statutes, Section 112.313, "Standards of Conduct for Public Officers and Employees of Agencies" (2004)

Other Resources:

AAMC Task Force on Financial Conflicts of Interest in Clinical Research, "Protecting Subjects, Preserving Trust and Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Research" (December 2001)

AAMC Task Force on Financial Conflicts of Interest in Clinical Research, Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research" (October 2002)

Department of Health and Human Services--Final Guidance Document--

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 5, 2004)

Miscellaneous COI Information from the NIH Office of Extramural Research

Executive Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), "PhRMA Code on Interactions with Healthcare Professionals" (July 1, 2002; revised January 2004)

FDA Guidance for Industry, "Financial Disclosure By Clinical Investigators" (March 20, 2001)

AAU Report on Individual and Institutional Conflict of Interest (October 9, 2001)

NIH Guide, "Financial Conflict of Interest and Research Objectivity; Issues for Investigators and Institutional Review Boards" (June 5, 2002)

Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy

Department of Veterans Affairs - Conflict of Interest in Research Handbook 1200.13

AcademyHealth - "Ethical Guidelines for Managing Conflicts of Interest in Health Services Research"

I. Purpose and Scope of Policy

This policy relates to conflicts of interest and conflicts of commitment and applies to the University of South Florida as an institution, to Institutional Officials, and to all USF Health officers, faculty, staff, students and committee members involved in the academic, research, clerical, or managerial mission of the University ("USF Health-Affiliated Individuals").

USF Policy 0-309, Conflicts of Interest in Sponsored Research, assigns responsibility for the review of conflicts of interest in all research involving human subjects to the USF Health COI Committee. Accordingly, Section III.A. of this policy dealing with the disclosure and review of conflicts of interest in research applies to any person, whether or not affiliated with USF Health, during the time when such person is conducting research involving human subjects at or on behalf of the University. For ease of reference, the term "USF Health-Affiliated Individuals" will include all such persons conducting research with human subjects where the policy addresses the principles of conflict of interest in research throughout the policy, and in the procedures for the review and disclosure of conflicts of interest in research set forth in Section III.A. of the policy.

The primary purposes of this policy are to educate USF Health-Affiliated Individuals about situations that generate conflicts of interest, to inform USF-Health Affiliated Individuals of their disclosure responsibilities, provide an efficient method for making disclosures, and facilitate effective identification and management of conflicts of interest and commitment. This policy also provides a process for the disclosure, review and management of institutional conflicts of interest in research conducted by the institution. Every Institutional Official and USF Health Affiliated Individual has an obligation to become familiar with, and abide by, the provisions of this policy.

This policy is also intended to fulfill the requirements of Public Health Service (PHS) Regulations, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought" (42 CFR Â§50), and the National Science Foundation (NSF) rules on "Objectivity in Research" in the Federal Register on June 19, 1995. The National Institutes of Health (NIH) reprinted the rules in the "NIH Guide for Grants and Contracts," Volume 24, Number 25, dated July 14, 1995 (NIH Guide). Effective October 1, 1995, these regulations mandate that institutions have written policies and procedures that require each Investigator to disclose, by the time an application is submitted for a PHS or NSF award, any and all Significant Financial Interests that would reasonably appear to be affected by the research.This policy also incorporates the requirements of the Food and Drug Administration (FDA) Regulations, "Financial Disclosure By Clinical Investigators" (21 CFR Part 54) (April 1, 2002).

This policy requires disclosure of all financial interests related to research, regardless of the magnitude, appropriateness, time or location of the activity, and regardless of whether the financial interest reaches the "significant financial interest" threshold established by the federal law.

Further, only through the process of full disclosure and review by the COI Committee or the COI Administrator can an Investigator be assured that his or her research activities are approved and sanctioned by the University. Once proposed activities have undergone administrative review and a plan of action developed and approved, the University will defend the activity as long as the Investigator complies with the disclosure process, the management plan, the applicable University policies and the law.

Conflicts of interest are common and practically unavoidable in an academic research setting. However, USF Health-Affiliated Individuals should conduct their affairs so as to avoid or minimize conflicts of commitment or interest, and must respond appropriately when conflicts of commitment or interest arise.

II. General Principles

A. Preamble

What is a Conflict of Interest?

Depending on the nature of an individual's principal professional role, he or she has primary interests that stem from that role. For teachers, it is educating their students; for physicians, it is promoting the well-being of their patients; for judges, it is ensuring that justice be done. For all researchers, the primary interest is to generate and disseminate valid and reliable research and to ensure integrity in the process.

In addition to the primary interest, individuals customarily have numerous secondary interests that originate from their other interests, personal commitments, and roles. These secondary interests of researchers include teaching, administration, financing research, political advocacy, obligations to employers, and financial, as well as family and other vocational interests.

The presence of a secondary interest is not unethical or prohibited. What makes these interests potential conflicts is their ability to unduly influence decisions that compromise the research role. Thus, a conflict of interest can occur when secondary interests distort the integrity of judgments regarding the primary interest.

In the research context, secondary interests can not only affect (or have the appearance of affecting) collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods. Investigators should consider the potential effect that having a financial relationship of any kind with a commercial sponsor of a study might have. Relationships that lead an Investigator to prefer one outcome to another may influence an Investigator's judgment and behavior. All aspects and types of relationships need to be considered, including such clear-cut conflicts as financial incentives, serving as a paid consultant or speaker on behalf of a commercial sponsor, and less obvious ones such as non-monetary inducements or rewards to Investigators or their family members.

It is not possible to completely eradicate the potential for conflict of interest because there are certain rewards that are inherent in the structure of our research enterprise. Such rewards may be completely unrelated to relationships with industry or private sponsorship. For example, positive research results per se may contribute to opportunities for publication, promotion, tenure, grant renewals, and so forth. In addition, positive results are often more gratifying and lead to greater personal satisfaction than negative outcomes. In a sense, these influences can be as much a source of conflict in search for truth as interests of a pecuniary nature. But kept in perspective, such incentives are not inherently bad and are indeed the motivating forces for diligent scientists. Such conflicts become detrimental when the potential rewards, financial or otherwise, cause deviation from absolute objectivity in the design, interpretation, and publication of research activities, or in other academic and professional decisions.

Conflicts of interest also have the potential to bias other aspects of academic life, particularly when USF Health-Affiliated Individuals are in a position to set University or hospital policies, manage contracts, select equipment and supplies, involve students in sponsored projects, or have other administrative roles in which objectivity and integrity are paramount.

There is an inexhaustible matrix of situations in which USF Health-Affiliated Individuals may find themselves, and it would be impossible for this document to provide a comprehensive list. Therefore USF Health-Affiliated Individuals should endeavor to avoid even perceptions by others of conflicts of interest and should take a particularly active role in ensuring ethical conduct regarding conflicts of interest in research. It is imperative that Investigators adhere to ethical guidelines and maintain a clear personal code of ethics that might both prevent such conflicts in the first place and help to manage them when they arise. Investigators are responsible for acting in an ethical manner while representing the University and conducting researchâ€"not only because their profession demands it, but also because such personal ethics will ultimately help to mitigate conflicts of interest and will lead to a more ethical mode of professional conduct.

Actual vs. Perceived Conflicts of Interest

When referring to conflicts of interest, many commentators distinguish between actual and perceived conflicts of interest. An actual conflict of interest occurs when secondary interests objectively distort judgment. It is important to note that individual actors, as well as outsiders observing them, will typically be uncertain about the true motivations for specific decisions and actions.

Observersâ€"and even actors themselvesâ€"can be unsure about which of myriad considerations and interests ultimately influenced a person's judgments. The distance of observers, and the inherent limitations on their access to knowledge about decisions, means their perceptions about the influence of interests may well differ from those intimately involved in a process or activity. Uncertainty about what interests a person has and how these interests influence decision-making in a process or activity can cast suspicion on the integrity of the judgments. Thus, a perceived conflict of interest occurs when a reasonable person could perceive that a secondary interest might unduly affect the integrity of a judgment regarding a primary interest. Since it is impossible to know for certain what considerations influence judgments, even the perception of a conflict of interest is ethically worrisome and requires prevention, prohibition, or remediation.

Financial Interests in Research

Academic institutions are turning increasingly to private funds as a source of support for research. Moreover, current federal policies encourage institutions to seek private investment as a vehicle for translating academic biomedical research into medically useful products. Under the regulations implementing the Bayh-Dole Act of 1980, institutions and Investigators are to share in the return on successful inventions arising from federally funded research.

Bayh-Dole is widely viewed as having created incentives for socially useful collaboration between academia and industry. The resulting commercialization of research harnesses the collective intellectual and creative talents of university faculty, speeds the development of new and improved therapies, stimulates regional economic growth, and contributes to the economic viability of research institutions. Notwithstanding these benefits, the increasing involvement of academics in commercially sponsored research places new demands on institutions to be scrupulous in crafting and enforcing their conflict of interest policies, and on Investigators to be diligent in adhering to them.

Because every person has numerous roles and interests, conflicts of interest are inevitable. While they may not always affect the decisions of the research team, conflicts must be appropriately managed. Left unchecked, these conflicts can threaten the credibility of the research team or the organization. More important, individual or organizational conflicts that are not dealt with can threaten the credibility of the entire field, raising suspicions about research and the integrity of researchers in general.

Ensuring the integrity of judgment of individuals and the field requires that these conflicts of interest in the research setting be properly managed. To be useful, any management strategy must be sensitive both to legitimate competing interests and to the many considerations of actual practice, while simultaneously retaining sufficient specificity to guide action in an ethically acceptable manner.

An institution can also be subject to conflicts of interest and perceptions of conflicts of interest when the institution has a stake in the outcome of the research through royalties, equity interests, participation of institutional officials in entities related to the research and other proprietary and relational connections to the research conducted by the institution.

By working together to manage these conflicts, the Investigator, institution, responsible administrators and the USF Health Conflict of Interest Committee ("COI Committee") can guard employees and the institution from engaging in research activities where the risk to integrity and safety of subjects as a result of external relationships outweighs the value of the activity to academic and societal goals.

B. Conflicts of Interest in Clinical Research (Involving Human Subjects)

The University and its faculty, staff, and students who conduct research involving human subjects must commit to the safety and welfare of those subjects and the integrity of the research above their own financial interests or the pursuit of personal gain. The safety and welfare of human subjects, institutional integrity and the public trust are the researcher's highest priority. Any conflict that threatens these objectives must be eliminated or strictly managed. The financial interests of investigators must be managed so that they do not adversely affect participant protections or the credibility of the research protections program. Human subjects research is not a right but a privilege. This privilege imposes certain obligations on the researcher and the University.

Opportunities to profit from research may affect - or appear to affect - a researcher's judgments about which subjects to enroll, the clinical care provided to subjects, even the proper use of subjects' confidential health information.

Accordingly, it is the policy of this University to regard all financial interests in human subjects research as potentially problematic and, therefore, as requiring strict scrutiny. This policy and the related implementing documents of the COI Committee establish the rebuttable presumption that an individual who holds a financial interest in research involving human subjects may not conduct such research. The intent is not to suggest that every financial interest jeopardizes the welfare of human subjects or the integrity of research, but rather to ensure that 1) any and every financial interest that might give rise to the perception of a conflict of interest is reported and systematically reviewed, and 2) that the conduct of human subjects research by Interested Investigators is limited to those situations in which the circumstances are compelling. The presumption against financial interests in human subjects research applies whether the research is funded by the University, any other public agency, a non-profit entity, or a commercial sponsor, and at every site where the research may be carried out.

In the event of compelling circumstances, an Interested Investigator may be permitted to conduct research involving human subjects. Whether the circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. When the financial interest is directly related to the research and may be substantially affected by it, the risk is greatest and the bar must be high.

If the research proposal involves research with human subjects, any financial interests associated with the research proposal must be reviewed by the COI Committee prior to final IRB review/approval of the research. COI Committee findings and determinations should guide the IRB's review of any research protocol or proposal, and the IRB may require additional safeguards or demand reduction or elimination of the financial interest.. The IRB will have the final authority to decide whether the interest and its management plan will allow the research to be approved.

C. Conflict of Interest in Basic Science and Pre-Clinical Research

At the crucial interface between scientific innovation and product development, academic Investigators often play a critical role by conducting early translational research that gives rise to new products, and by testing these novel products. The opportunity for Investigators to receive financial rewards from these endeavors is not intrinsically unacceptable, as long as this opportunity does not adversely influence scientific decision-making or interfere with the researcher's responsibility to the University.

Of special concern is basic research that may be pre-clinical in nature. Basic research which will eventually give rise to clinical research should be the subject of even more careful management and scrutiny. Leaders in a field of research may engage in pre-clinical research in that field and should be particularly attuned to conflicts of interest. For example, basic research results which will be the basis for clinical research should be independently confirmed to avoid future questions about research integrity or human subject safety. Such Investigators have an independent responsibility and should take special care to ensure that such research is free of bias.

Conflicts of interest in research not involving USF Health Affiliated Individuals are managed according to the University's Policy on Conflicts of Interest in Sponsored Research (USF Policy 0-309).

D. Conflict of Commitment

Appointment as a faculty member of this University confers the privilege and obligation to pursue teaching, research, scholarship, clinical care and service (whichever are appropriate to the position held). University employees owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to these activities that are associated with their University employment.

A University appointment also conveys an obligation for a faculty member to have a significant presence on the University campus (or at affiliated institutions), to fulfill primary obligations to the University, to be accessible to students and staff, and to be available to other University employees, patients or affiliates throughout each semester of the faculty member's appointment, unless the department chair and/or dean has granted specific prior approval for absences that would interfere with accomplishing academic responsibilities. The specific responsibilities and professional activities that constitute an appropriate and primary commitment should be based on a general understanding between the employee and his or her department chair, dean or supervisor and may differ as among colleges, departments and disciplines.

Even with such understandings in place, however, attempts of employees to balance University responsibilities with outside activities â€" such as consulting, public service or pro bono work â€" can result in conflicts regarding allocation of time and energies. Conflicts of commitment usually involve issues of time allocation.

Time Allocation between University Duties and Outside Interests. Certain faculty assignments have specific accountability relative to time commitments. However, for the remainder of a faculty member's academic pursuits, there is no universally applicable standard or formula for determining appropriate levels of faculty effort with respect to allocation of time that is recognized by this University. It is the philosophy of the University that a system of precise time accounting is incompatible with the inherent character of the work of a faculty member. Outside activities may be pursued 1) only after consultation with the employee's supervisor to determine the expectations of the supervisor regarding the fulfillment of the employee's primary commitment of time, presence and objectives and 2) as long as the employee's commitment to the University have been fulfilled.

In sum, employees who wish to engage in outside activities should:

Fully disclose the outside activity in the manner described in this policy,
Meet with supervisor to determine supervisor's expectations regarding the employee's primary commitment of time, presence, and objectives,
Assure that research, teaching, and public service obligations to the University are fully met,
Abide by restrictions on the type and amount of outside activity as determined by the Designated University Official,
Abide by commitments of effort as specified in contractual research agreements and grant applications, and
Be discriminating in the selection of outside commitments, regardless of whether they are professional or non-professional in character, and regardless of whether the obligation is to be discharged in "off hours" or during vacation.

F. Conflict of Interest with University Employment

A conflict of interest with University employment may or may not involve a conflict of commitment. Whereas a conflict of commitment primarily relates to issues of time allocation, a conflict of interest can occur whenever there is a divergence between a individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A conflict of interest depends on the situation, and not on the character or actions of the individual.

Florida law prohibits an employee or public officer from doing business with his or her own agency. See Florida Statutes, §112.313(3).

Florida law also prohibits conflicting employment or contractual relationships by public employees and officers. See Florida Statutes, §112.313(7)(a).

Nothing in this policy is intended to discourage an employee from engaging in outside activity in order to increase his or her professional reputation, service to the community, or income, subject to the requirements of this policy. As discussed above, an employee shall not engage in any outside activity that interferes with the full and competent performance of the employee's duties on behalf of the University.

USF is an institution of public trust; employees must respect that status and conduct their affairs in ways that will not compromise the integrity of the University.

Conflicts of interest can also compromise a faculty member's academic performance. It is expected that faculty will foster an atmosphere of academic freedom by promoting the open and timely exchange of results of scholarly activities, ensuring that their advising of students and postdoctoral scholars is independent of personal commercial interests, and informing students and colleagues about outside obligations that might influence the free exchange of scholarly information between them and the faculty member.

III. Disclosure and Review of Conflicts of Commitment and Conflicts of Interest

A. Requirement for Disclosure of Investigator Financial Interests and External Commitments in Research

1. Purpose

The purpose of this Section III. A. is to implement the requirements adopted by the U.S. Public Health Service (PHS), which includes the National Institutes of Health (NIH), and the National Science Foundation (NSF) concerning the prevention of bias in the design, conduct or reporting of research by managing, reducing, or eliminating actual or potential conflicts of interest. The Florida Code of Ethics for Public Officers and Employees prohibits conflicts of interest for all state employees, including university faculty and staff.

2. Scope of Disclosure Responsibilities

This section, III.A., of the policy applies to:

any USF Health-Affiliated employee or person who is conducting research involving human subjects
at or on behalf of the University of South Florida
who qualifies as an Investigator as defined in this policy.
regardless of the funding source or regulatory oversight for the research.

The term "Investigator" includes the Investigator's Immediate Family. Disclosure and evaluation of the financial interests reportable under this policy will take into account the aggregate interests held by the Investigator and his or her Immediate Family, and applies to interests held during the time the Investigator is carrying out the study and for 1 year following completion of the study.

3. What to Report

a. Reportable Financial Interests and External Commitments.

Investigators must disclose all financial interests or external commitments that relate to, or could be reasonably affected by, the outcome of, the proposed or current Research Project ("Reportable Financial Interest or External Commitment"). Such interests and commitments are defined to include

Anything of monetary value, or a potential value that cannot readily be determined, including, but not limited to, salary or other payments for services (e.g. consulting fees or honoraria) which is paid or given to the Investigator (or the Investigator's Immediate Family) directly, indirectly, as support for the activities of the Investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria), or in trust by any other means;
a proprietary interest in the Research Project, including a patent, trademark, copyright, licensing agreement or other intellectual property interest in the test article or method;
a position as director, officer, partner, trustee, or member of board of directors of any entity Related to the Research;
a consulting, advisory, employment, ownership/equity or any other interest or relationship in any entity Related to the Research (including interests in a non-publicly traded corporation the value of which interests cannot be readily determined through reference to public prices);
or any other financial interest or external commitment that the Investigator believes may interfere with his or her ability to protect human research participants.

All financial interests and relationships 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 law.

b. What Not to Report.

There is no minimum amount below which an interest is exempt from reporting. However, the following financial interests and commitments are generally recognized as not relating to or not being impacted by the outcome of the research and therefore do NOT need to be disclosed:

Salary, royalties or other remuneration received from USF or the USFPG.
Receipt of royalties for any published scholarly works and other writings.
Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities. NOTE: All honoraria received from commercial entities must be disclosed.
Income from service on advisory committees or review panels for public or nonprofit entities.
Interests in commercial enterprises on the part of an Investigator which commercial enterprises are in no way related to the Investigator's professional role and/or obligations.
Any "arms length" financial interest (i.e., those that occur through participation in a mutual fund or employer retirement plans), where the participant has no control over the investment decision, except where the value of the equity in a publicly traded company Related to the Research exceeds $50,000

4. Process for Reporting Investigator Financial Interests or External Commitments Related to a Research Project

a. Financial Relationships Disclosure form. All Investigators who have a Reportable Financial Interest or External Commitment in a Research Project must complete the University's Financial Relationships Disclosure Form (FRDF) and have the form reviewed and signed by the Investigator's supervisor.

A Financial Relationships Disclosure Form must be completed for each Interested Investigator involved in the Research Project. If the Research Project is carried out through a subcontractor or collaborator, the University, through its Division of Sponsored Research (DSR), shall require the subcontractor or collaborator to certify that all Investigators working on the Research Project are in compliance with a conflict of interest policy that satisfies the requirements of this policy.

b. Triggering Events. Interested Investigators must submit the FRDF:

i.    Upon Initial Submission of Research Proposal to DSR (for sponsored research) or to the Investigator's Department Chair or Committee (for non-sponsored research) and prior to engaging in the research.

ii.    Upon Joining a Research Project. An Interested Investigator who joins a Research Project underway must submit the FRDF within 60 days of beginning work on the research.

iii.    Upon Acquisition of Any New Reportable Interests. Investigators who have previously submitted an FRDF, but who acquire new Reportable Financial Interests or External Commitments or otherwise have a change in the status of

such interests must submit a new FRDF within 60 days of the acquisition or change in interest.; and

   iv.    Annually, upon receiving a request from DSR to certify the status of the Investigator's Reportable Financial Interests or External Commitments. The University, through its Division of Sponsored Research, will request that an

Investigator provide annual updates of reportable interests during the period of an award funded by PHS. However, DSR may request that the Investigator complete a short disclosure form or other certification document in lieu of the

FRDF. Instructions for completion of such annual disclosure forms/certifications will be included with the request from DSR.

c. Where to Submit the FRDF. Investigators should submit the FRDF:

i. For sponsored research: to the Division of Sponsored Research upon occurrence of any of the triggering events identified in III.4.b.

ii. For non-sponsored research: to the USF Health Conflict of Interest Committee, c/o the USF Health COI Administrator.

5. Submission of Form and Review by Institutional Official

Financial Relationship Disclosure Forms will be submitted directly (for non-sponsored research) or routed through DSR (for non-sponsored research) to the USF Health COI Administrator, who is the Responsible Institutional Official for oversight of Investigator financial interests and external commitments in research. The Responsible Institutional Official will review the form and may discuss with the Investigator any potential conflicts before making a final determination regarding the management, reduction or elimination of the conflict or apparent conflict. If the research involves human subjects, the matter will be forwarded to the USF Health COI Committee for review and determination of whether compelling circumstances exist to rebut the presumption that the Investigator may not conduct the research. Where certain conditions are met, the research proposal may receive administrative approval by the Responsible Institutional Official without the necessity of full board review. The Investigator will be advised of the determination.

6. Review by COI Committee (and IRB)

If the Investigator disagrees with the determination of the Responsible Institutional Official, or if the research involves human subjects, the Responsible Institutional Official will submit the Financial Relationships Disclosure form and any relevant documentation to the COI Committee for consideration and resolution through management, reduction or elimination of the conflict or apparent conflict. Disclosure of the investigator's interest alone is not sufficient to manage an investigator's interest that might adversely affect participant protections.

The COI Committee's determination shall be final if the research does not involve human subjects. If the research involves human subjects, the IRB will have the final authority to decide whether the interest and its management plan will allow the research to be approved.

Upon completion of its review and identification of a management plan for research involving human subjects, the COI Committee will forward the Financial Relationships Disclosure Form and any relevant documentation to the IRB for use by the IRB in its review process. The IRB may accept the management plan, modify the management plan to make it more (but not less) stringent, or may disapprove the management plan and determine that the research may not proceed unless the Investigator's financial interest is divested. For other research, the Investigator will be advised of the final determination by the COI Committee.

7. Special Considerations Involving Human Subjects Research

As a general rule, an Interested Investigator may not conduct the human subjects research in which the investigator has an interest. This rule is not intended to be absolute: an Interested Investigator 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. The financial interests of investigators must be managed so that they do not adversely affect participant protections or the credibility of the research protections program.

Compelling circumstances are those facts that convince the institution's COI Committee that an Interested Investigator should be permitted to conduct human subjects research. When considering such a request, the circumstances that the COI Committee should evaluate include the nature of the research, the magnitude of the interest and the degree to which it is related to the research, the extent to which the interest could be directly and substantially affected by the research, and the degree of risk to the human subjects involved that is inherent in the research protocol. The committee should also consider the extent to which the interest is amenable to effective oversight and management.

When the financial interest is directly related to the research and may be substantially affected by it, (e.g., an equity interest in a start-up company that manufactures the investigational product) the risk is greatest and the bar must be high; however, even direct and potentially lucrative financial interests may be justified in some circumstances. For example, when the individual holding such interests is uniquely qualified by virtue of expertise and experience and the research could not other-wise be conducted as safely or effectively without that individual, he or she should be permitted the opportunity to rebut the presumption against financial interests by demonstrating these facts to the satisfaction of the COI committee. The COI committee might approve the involvement of such an individual in the research, subject to conditions that ensure effective management of the conflict and credible oversight of the research.

At the discretion of the COI Committee, the existence of any financial interest held by the Investigator and the institution may be required to be disclosed:

1) in the research consent forms, where deemed appropriate by the IRB. The precise wording of the disclosure in the consent form should be determined by the IRB, but should include an explanation of the fact that the financial interest in question has

been reviewed by COI committee, approved subject to oversight, and determined by both COI Committee and the IRB not to pose any additional significant risk to the welfare of research subjects or the integrity of the research. The disclosure

statement should also indicate that all approving authorities have disclosed any conflict and that additional information will be provided to research subjects upon request. Disclosure of the investigator's interest alone is not sufficient to

manage an investigator's interest that might adversely affect participant protections.

2) to state and federal officials if required by statute or regulation.

3) to research sponsors or granting agencies.

4) to the editors of any publication to which the Investigator submits a manuscript concerning the research;

5) to trainees and prospective collaborators; and

6) in any substantive public communication of the research results, whether internal or external, oral or written.

In addition, the COI Committee shall prohibit payments to the Investigator from the sponsor or University which payments are conditioned upon a particular research result or are tied to a successful research outcome. Payments for subject enrollment or referral of patients to research studies should be permitted only to the extent that such payments 1) are reasonably related to the costs incurred, as specified in the research agreement between the sponsor and the Investigator/institution; 2) reflect the fair market value of the services performed; and 3) are commensurate with the efforts of the individual performing the research.

8. Agency notifications (PHS only).

If a potential conflict of interest is identified at the time a proposal is submitted to any sponsoring institute or agency of the Public Health Service, and that proposal is subsequently awarded, or if a potential conflict is identified subsequent to the award of the project, the COI Administrator will coordinate with the Director of DSR to notify the administrative officer for the awarding agency that the University has identified a potential conflict of interest in regard to the subject proposal, and has taken appropriate action to manage, reduce or eliminate that conflict. The Public Health Service does not require, nor does it want, any explanation of the details of the potential conflict situation. Notification will be made prior to any expenditure of project funds if a potential conflict has been disclosed in advance of the award or within 60 days of the disclosure if the potential conflict is disclosed subsequent to the award. This notification requirement applies only to the Public Health Service, including the National Institutes of Health (NIH).

B. Requirements for Reporting Of Institutional Financial Interests and External Commitments in Research

1. Purpose

In the research context, not only can individual interests pose a conflict, but since much of the research is conducted within organizations, different actors in the same organization and even on the same research team can have different interests. This reality can easily lead to intra-organizational conflicts of interest.

Any perception that an institution has a conflict of interest, especially in research with human subjects, weakens public support for research funding. The COI Committee will review both management systems as well as potential conflicts by individuals in positions of authority.

3. Scope of Disclosure Responsibilities

This section III.B. of the policy applies to

the USF Office of Research, Division of Patents and Licensing, on behalf of the University of South Florida ("institution")

i. when the institution is entitled to receive royalties from the sale of the investigational product;

ii. when the institution has obtained an equity interest in a non-publicly traded sponsor;

iii. when, through technology licensing activities or investments, the institution has obtained an ownership interest or an entitlement to equity of greater than $100,000 in value, in a publicly-traded sponsor;

iv. when other special circumstances arise, including times when the institution has received substantial gifts from a potential commercial sponsor of human subjects research; and

Institutional Officials who hold a significant financial interest in the commercial research sponsor or the investigational product for a Research Project conducted at or on behalf of the institution.

3. What to Report

Institutional Officials must disclose all Significant Financial Interests that relate to, or could be reasonably affected by, the outcome of, the proposed or current Research Project. Such interests are defined to include

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 year or $50,000 over the course of the study and one year thereafter when aggregated for the Institutional Official and his or her Immediate Family.
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 Institutional Official and his or her Immediate Family.
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

4. Process for Reporting Institutional Financial Interests or External Commitments Related to a Research Project

[This section is under construction]

C. Requirements for Reporting Of Outside Activity

1. Generally

An employee shall not engage in any outside activity that interferes with the full and competent performance of the employee's duties on behalf of the University.
An employee engaging in any outside activity shall not use the facilities, equipment, or services of the University in more than an incidental manner in connection with such outside activity without prior written approval of the Vice President for Health Sciences. Such approval may be conditioned upon reimbursement for the direct costs resulting from the use thereof.

2. Timing and Scope of Reporting Responsibilities

All employees who propose to engage in any outside activity which the employee should reasonably conclude may create a conflict of interest are to complete an USF Health Report of Outside Activity and submit it to the Designated University Official:

Upon initial employment with the University
Prior to engaging in any new outside activity
Annually thereafter for continuing outside activity (with the reporting period being July through June 30)
Any time there is a significant change (e.g., nature, extent, funding) to previously reported and approved outside activities.
Any outside activity in which the employee is currently engaged but has not previously reported, shall be reported within (45) days of the effective date of this policy. Failure to report outside activity as required pursuant to this
policy will shall constitute grounds for disciplinary action.
The University recognizes that certain matters that are the subject of outside activities may be confidential, for example, matters which are exempt from disclosure pursuant to sections 240.299 and 240.241 of the Florida Statutes relating to trade ....... .secrets, potentially patentable material and other proprietary information. Confidential aspects of outside activities need not be disclosed in the Outside Activity form, but the financial and commitment aspects of the activity should be reported.
.Institutions and USF Health-Affiliated Individuals bear a shared responsibility for the oversight of conflicts of commitment.

3. What Outside Activities to Report

The following outside activities MUST BE REPORTED AND APPROVED PRIOR TO ENGAGING IN THE ACTIVITY:

outside outside activities in which there is more than an incidental use of University facilities, equipment, and/or services.
outside activities in which a University student or other University employee is directly or indirectly supervised by the employee if the employee in any way supervises or evaluates the student or other employee at the University.
management, employment, consulting, and contractual activities with, or ownership interests in, a business entity (or state agency) that does business with the University. In the case of material financial and managerial interests, the information requiredextends to the spouse and children of the employee, and for managerial interests, to relatives.
management, employment, consulting, and other contractual activities with, or ownership interest in, a business entity which competes with the University.
candidacy for public office.
required use of books, supplies, equipment, or other instructional resources at the University of South Florida when they are created or published by the employee or by an entity in which the employee has a financial interest.
professional compensated activities, including, but not limited to consulting activity related to the employee's field of discipline, teaching at another institution, participating in an activity in which an honorarium in excess of travel expenses is to be received, and employment as an expert witness.
business activities, including membership on an advisory council, scientific advisory board, service on the board of directors or other management interests or positions, with regard to a business entity with activities in the same discipline or field in which the faculty or staff member is employed.
any employment, contractual relationship, or financial interests of the employee which may create a continuing or recurring conflict between the employee’s interests and the performance of the employee’s public responsibilities and obligations, including time commitments. This includes any outside activity in which the employee is required to waive rights to intellectual property and any outside activity or financial interest with a business entity that supports the employee’s research or training program at the University.
outside activities and financial interests required to be reported under federal contract and grant regulations.
other activities that the employee should reasonably conclude may create an actual or apparent conflict of interest, including a conflict of time commitments.

4. How to Report Outside Activities

The required disclosure should be made on the USF Health Report of Outside Activity form annually and updated to report changes or additional activities.

name of employing or contracting entity or person, or name of entity in which the financial interest is held, and nature of its business.
involvement of students and other employees in the activity, employing entity, or entity in which the financial interest is held, if that involvement is known to the employee making the disclosure.
nature of activity or financial interest (description of equity interest or intellectual property), including time spent if an activity is involved (estimated hours per week including travel time). The source and type of compensation must be noted, location and anticipated dates of activity.
any conditions of the activity which involve waiving or impairing the employee's or University's rights to intellectual property.
use of University's equipment, facilities, or services in more than an incidental way in connection with the activity.
number of other outside activities and financial interests previously filed for the contractual year.
prior approval of the activity or financial interest in the previous contractual year, if applicable.

Other information may also be requested in order to assume a complete review of the activity if there are potential conflicts involved. All individuals have responsibility for the reporting powers and of assuring its proper management.

5. Submission of Outside Activity Form and Review by Designated University Official

Employees shall submit the completed USF Health Report of Outside Activity to the Designated University Official within sufficient time to secure the appropriate approvals before engaging in any outside activity. The Designated University Official shall review the form and discuss the matter with the employee within fourteen (14) days of the employee's written notification. If the matter is unresolved following this discussion, the employee may refer the matter to the Dean of the College. The Dean shall review the matter within fourteen (14) days of the referral. If the matter remains unresolved, the employee may refer the matter to the Vice President for Health Sciences who shall determine whether the outside activity creates an unmanageable conflict of interest or otherwise interferes with the employee's University duties. The employee shall be notified in writing of the Vice President's determination within thirty (30) days of the date that the matter was referred to the Vice President.

The employee may engage in the outside activity pending the decision of the Vice President. If the Vice President determines that there is a conflict of interest or other interference with the employee's duties, the employee shall cease such activity immediately and turn over to the University any compensation earned therefrom.

6. Special Considerations for Outside Activity Involving Students, Trainees, Junior Faculty and Support Staff

Junior Faculty. Senior faculty may offer junior faculty opportunities for professional development through involvement in outside professional activities. However, senior faculty must not compromise their objectivity in evaluating their junior faculty in issues of promotion and tenure by virtue of outside professional activities in collaboration with junior faculty members, nor should senior faculty allow internal relationships with junior faculty to influence external relationships, expectations, or assignments. The Designated University Official should approve any new involvement or change in outside professional relations of senior and junior faculty after joint discussion with both senior and junior faculty concerned.

Students or Trainees. Part-time involvement of students or trainees in the outside professional activities of faculty may, under certain conditions, offer the potential for substantial benefits to the education of the student. In each case of such involvement, the faculty member should obtain prior approval from the Designated University Official after discussion with the Designated University Official and the student. In this context, involvement means any substantive activity, whether paid or unpaid.

In considering such arrangements, faculty should be guided by the need to avoid conflicts of interest and to avoid infringement upon the student's academic duties and rights. Generally, if the faculty member has a role in supervising the student's thesis or in supervising the work of the student as a graduate teaching assistant or instructor, such outside involvement should not be undertaken--thus avoiding potential conflicts of interest in the evaluation of the student's performance. If the faculty member does not have a role in supervising the student's thesis and/or the student's work as a teaching assistant or instructor, such involvement may be undertaken. If the outside work is related to the student's thesis, special care should be taken to avoid conflict.

If faculty members are already associated with students in outside professional activities, they should disqualify themselves from becoming research supervisors, academic program advisors, or examiners for an advanced degree of those students. Within a USF research laboratory or academic unit, faculty members should take care not to give the impression of favoritism to those students with whom they are associated in outside activities. Generally, full-time research assistants should not be involved in outside professional activities of faculty--both to avoid conflicts of interest and in light of the obligations of full-time research assistants. A part-time research assistant may engage in such activity if the outside work is not thesis-related and if the faculty member is not his or her supervisor.

Support Staff. Support staff play an important role in assisting the faculty with their USF teaching, research, and administrative activities. It may also be appropriate for support staff to assist faculty members in their outside professional activities, depending upon the nature and extent of the support staff involvement. Such involvement, however, is a potential source of conflict between faculty and their support staff. It is especially important, therefore, that faculty discuss with their support staff the appropriateness of any such support activities requested. Any special arrangements for providing support for faculty outside professional activities, including compensation from non-USF sources, must be acceptable to all the parties involved. If support staff will be compensated for work on outside professional activities, such work must be performed on the staff members' own time and not during hours compensated by the University.

Guidelines defining appropriate support are given below; faculty members should discuss any circumstances that do not obviously meet these guidelines with the Designated University Official.

It is normally appropriate for support staff to assist faculty in their professional public service activities, i.e., those professional activities in which faculty provide a service to institutions other than the University for public benefit, and in which compensation is incidental. If the effort required to provide such support is likely to be substantial and long term, however, a faculty member should review the circumstances with his or her Designated University Official.
It may also be acceptable for support staff to provide limited assistance to faculty in other types of outside professional activities. Any assistance provided for such outside activities must not be in conflict with the faculty and support staff's responsibilities to the University.
Faculty may not require support staff to perform duties related to the faculty member's personal and nonprofessional activities.

7. Use of University Resources in Outside Activity

Employees may not use University resources, including facilities, personnel, equipment, or confidential information, except in a purely incidental way, as part of their outside activities or for any other purposes that are unrelated to the education, research, scholarship, and public service missions of the University.

Under special circumstances (e.g., start-up phase of University-based company) use of University resources may be permitted with appropriate reporting to and discussion with the Designated University Official and may be conditional upon reimbursement for direct and indirect costs resulting from such use.

IV. Sanctions

The Vice President for Health Sciences is responsible for overseeing the implementation of the USF Health COI policy. The Vice President or designee will review all allegations of breaches of the conflict of interest management process including: A) failures to comply with such process, whether by refusal to respond, or response with incomplete or knowingly inaccurate information; B) failures to remedy conflicts; and C) failure to comply with the prescribed oversight plan. Such cases may be forwarded to the Conflict of Interest Committee, which Committee will make recommendations to the Vice President for further action. Faculty members will be provided the explicit opportunity to respond in person and in writing to issues raised in the course of such review. Any such written response will be appended to the Committee's report for review by the Vice President.

Sanctions for violations of COI management processes may include the following, among others:

Dismissal from employment
Suspension without pay
Suspension of research activity
Monitoring of research activity
Required education
Demotion
Reduction of salary
Forfeiture of a portion of salary
Restitution of benefits received because of the violation
Reporting of conflicts to appropriate, University, corporate, State or Federal agencies

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 â€" 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 as "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.

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.

Immediate Family means spouse or domestic partner, and each dependent child.

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 affectâ€"or reasonably appear to affectâ€"institutional processes for the conduct, review, or oversight of research, especially human subjects research.

Institutional Official means in an institutional official in a position of oversight over research. The term includes Chairs, Associate Deans, Deans, Associate Vice Presidents, Vice Presidents and the University President.

Interested Investigator means an Investigator with Reportable Financial Interests or External Commitments.

Investigator means the Principal Investigator and every person (faculty, staff, students, and collaborators outside of USF) responsible for the design, conduct or reporting of a Research Project (regardless of the funding source or regulatory oversight of the research), including any investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects.

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 an Interested Investigator may not conduct the human subjects research in question. This rule is not intended to be absolute: an Interested Investigator 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.

Related to the Research: An entity or person related to the research would include

the Sponsor or Funding Source of the Research Project
the provider of any product being investigated through the Research Project
the holder of any ownership interest in a product or method being investigated

Any other entity whose financial interests would be reasonably affected by the outcome of the Research Project.

Reporting means the provision of information about 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).

Research Project: The individual research study, project or proposal at issue for which an Investigator discloses a Reportable Financial Interest or External Commitment pursuant to this policy.

Reportable Financial Interests and External Commitments: A financial interest or external commitment that relates to, or could be reasonably affected by, the outcome of the proposed or current Research Project. Such interest and commitments would include

Anything of monetary value, or a potential value that cannot readily be determined, including, but not limited to, salary or other payments for services (e.g. consulting fees or honoraria) which is paid or given to the Investigator (or the Investigator's Immediate Family) directly, indirectly, as support for the activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria), or in trust by any other means;
a proprietary interest in the Research Project, including a patent, trademark, copyright, licensing agreement or other intellectual property interest in the test article or method;
a position as director, officer, partner, trustee, or member of board of directors of any entity Related to the Research;
a consulting, advisory, employment, ownership/equity or any other interest or relationship in any entity Related to the Research (including interests in a non-publicly traded corporation the value of which interests cannot be readily determined through reference to public prices);
or any other financial interest or external commitment that the Investigator believes may interfere with his or her ability to protect human research participants.

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. The Senior Associate Vice President for Research, USF Health, is the Responsible Institutional Official for purposes of this policy.

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.

USF Health-Affiliated Individual means USF Health officers, faculty, staff, students and committee members involved in the academic, research, clerical or managerial mission of the University. The term also includes any person, whether or not affiliated with USF Health, during the time when such person is conducting research involving human subjects at or on behalf of the University where the policy addresses the principles of conflict of interest in research throughout the policy, and in the procedures for the review and disclosure of conflicts of interest in research set forth in Section III.A. of the policy.