USC Office of Compliance

FAQs

  1. What is a Conflict of Interest?

    A "Conflict of Interest" is a situation in which financial or other personal considerations compromise, or have the appearance of compromising, an individual's professional judgment in proposing, conducting, supervising or reporting research. Conflicts of interest include non-financial as well as financial conflicts, because non-financial interests can also come into conflict with a researcher's primary commitment to maintain scientific objectivity. Investigators should consider not only situations that are unacceptable, but also gray areas that might create the appearance of a conflict of interest. Although not an all-inclusive list, each of the following is a type of conflict of interest that must be disclosed:

    • Maintaining a private equity interest (e.g., stocks, stock options or other ownership interests not publicly traded) in a research sponsor or licensee, or in a company having an economic interest in the research, regardless of the value of such equity interest.
    • Maintaining a publicly traded equity interest of $10,000 or more (except when the ownership interest is managed by a third party such as a mutual fund), or .5% of the valuation of a research sponsor or licensee, or in a company having an economic interest in the research.
    • Holding a management role (e.g., director, officer, scientific or technical appointment where the investigator or research personnel has significant decision-making authority) in a research sponsor, licensee or in a company having an economic interest in the research; or any other instance where the investigator or research personnel has significant decision-making authority within the outside entity.
    • Using a student to perform services for a company in which the investigator, research personnel or the close relation of either has an ownership or management role when (1) the student is currently enrolled in an investigator, research personnel, or the close relation of either’s class; or (2) the investigator, research personnel or close relation of either currently supervise(s) the student in an academic capacity; or (3) the investigator, research personnel, or the close relation of either otherwise has the ability to influence the academic progress of the student.
    • Maintaining a financial interest or management role in a research sponsor of the investigator and/or research personnel’s laboratory.
    • Maintaining a financial interest or management role in a company which has given, or expressed interest in giving, a major gift to the investigator and/or research personnel’s department or school.
    • Accepting personal payments for services (i.e. consulting arrangements, non-managerial scientific or technical appointments) from any sponsor or any organization or individual having an economic interest in the investigator's research that totals $10,000 or more when aggregated in any 12-month period.
    • Accepting gifts, gratuities or special favors from an actual or prospective sponsor of an investigator’s research, other than occasional gifts of nominal or modest value (less than $50 in value or isolated invitations to meals). Investigators and/or research personnel who are healthcare providers are subject to additional requirements when accepting gifts, gratuities or special favors from pharmaceutical companies, medical device companies, health care suppliers and their employees or agents. For more detail, please review USC's Policy Regarding Relationships With Pharmaceutical Suppliers, Biotech and Device/Medical Equipment Manufacturers and Other Healthcare Suppliers.
    • Maintaining a financial interest or management role (see above) in a company that is negotiating a license to intellectual property from USC.
    • Receipt of intellectual property rights (e.g., patents, copyrights or royalties from such rights) from a research sponsor by an investigator, research personnel or the close relation of either.
  2. What are an investigator's responsibilities with respect to identifying conflicts of interest?

    Investigators are responsible for determining whether they or any of their research personnel have actual or potential conflicts of interest or commitment. Investigators should evaluate potential conflicts not only at the outset of research, but also at any time a change occurs in any financial or non-financial interest during the course of research. This continuing evaluation can occur at the time a new proposal is submitted, when a new relationship is established with an outside entity or when a prior relationship with an outside entity changes.

  3. Who are “Research Personnel”?

    Research personnel include any USC employee, whether faculty or staff, who contribute to a research activity, whether or not the research is funded, and regardless of status (for example, research associates, technicians, nurse coordinators, administrators and graduate assistants).

  4. What is a “Close Relation”?

    A close relation means the spouse, domestic partner or dependent child of an investigator or research personnel. In addition, a colleague, sibling, parent or other relation is considered a close relation when an investigator and/or research personnel knows that the individual maintains a conflict of interest that may be impacted by research the investigator and/or research personnel is conducting.

  5. What is the extent of an investigator's responsibility to determine possible conflicts of interest that may be maintained by research personnel?

    Investigators are responsible for confirming that all research personnel under their supervision and who are involved in proposing, conducting or reporting research have identified and disclosed any potential conflict(s) of interest, and that they comply with any measures put in place to manage the conflict. This can be accomplished through raising the issue at staff meetings, sending out a memo to research personnel under the investigator's supervision, or any other reasonable method of communication. Investigators should document all of their efforts to make this assessment.

  6. What is considered a “significant conflict”?

    A “significant conflict” is a conflict of interest that is presumed to be unacceptable unless the investigator or research personnel are able to present compelling circumstances that justify allowing the research to proceed despite the presence of the significant conflict. Significant conflicts include, but are not limited to:

    • Any conflict of interest in research involving human subjects, unless the conflict arises from the investigator or research personnel’s acceptance of payments for services that are less than $10,000 when aggregated in any 12-month period.
    • Using a student to perform services for a company in which the investigator, research personnel or the close relation of either has an ownership or management role when (1) the student is currently enrolled in an investigator, research personnel or the close relation of either’s class; or (2) the investigator, research personnel or close relation of either currently supervise(s) the student in an academic capacity; or (3) the investigator, research personnel or the close relation of either otherwise has the ability to influence the academic progress of the student.
    • Any sponsored research agreement with an outside entity in which the investigator, research personnel or the close relation of either:
      • Holds any private equity interest
      • Holds a publicly traded equity interest in excess of $50,000 in a research sponsor or licensee, or in a company having an economic interest in the research
      • Holds a management role in a research sponsor or licensee
  7. What does the CIRC consider sufficient “compelling circumstances” that would allow an investigator or research personnel with a significant conflict to remain involved with research?

    The CIRC determines on a case-by-case basis whether an investigator and/or research personnel have provided “compelling circumstances” that justify allowing the research to proceed despite the presence of a significant conflict. Compelling circumstances may exist when an investigator demonstrates that he or she is the only person capable of performing the research due to his or her unique talents or skills. For example, the research may involve experimentation to further develop an early stage discovery that requires the investigator’s unique insights and knowledge. In the case of human subjects research, the investigator should also demonstrate a low-risk of harm to human subjects.
    Please contact the Office of Compliance to assist in determining whether compelling circumstances may be present in situations where a significant conflict exists.

  1. What kinds of conflicts of interest are prohibited?

    Certain types of conflicts are prohibited under USC policy, as follows:

    • Transfer of intellectual property rights arising out of research conducted at USC to any outside entity
    • Any incentive payments, bonus payments, finder's fees or any type of payment or incentive based on outcome with respect to the proposal, conduct, supervision or reporting of research, or with respect to the evaluation of a product or service intended for a commercial market (e.g., a clinical trial for a pharmaceutical company), regardless of the amount of compensation or payments received
    • Any sponsored agreement in which publication rights are restricted for proprietary or other reasons, in combination with the investigator or close relation receiving any form of payment, holding any private equity interest or holding publicly-traded equity interests of $10,000 or more (except when the equity interest is managed by a third party such as a mutual fund) or .5% of the outside entity’s valuation, or holding a management role
    • Accepting gifts, gratuities or special favors from an actual or prospective sponsor of an investigator’s research, other than occasional gifts of nominal or modest value (less than $50 in value or isolated invitations to meals)
  2. What is a “conflict of commitment”?

    A "conflict of commitment" is a conflict between outside activities and a full-time employee’s responsibility to devote his or her primary professional loyalty, time and energy to his or her teaching, research, service, administrative and clinical duties, as applicable. Refer to USC’s Conflict of Interest and Ethics policy and the Faculty Handbook for more detail. In addition, conflicts of commitment should be disclosed to your supervisor and/or dean.

  3. If an investigator has a financial interest, management role or accepts compensation for personal services from an outside company and that outside company intends to collaborate with USC on an SBIR or STTR grant, can the investigator still participate in the portion of the research taking place at USC?

    In these circumstances, an investigator generally cannot act as both the investigator in the research taking place at USC while simultaneously maintaining a financial interest or management role, or receiving compensation for personal services, from the outside company. However, assuming adequate measures are in place to manage the conflict, an investigator can continue with his or her role in the outside entity if an investigator with no conflict performs the basic research taking place at USC.

  4. What if research involves human subjects and the investigator and/or research personnel receive payments for personal services under $10,000 from the sponsor?

    These types of payments must be disclosed to the IRB in connection with its review of the protocol. The IRB may require the investigator and/or research personnel to disclose this compensation to all human subjects during the informed consent process. The IRB may also refer these arrangements to the Conflict of Interest Review Committee depending on the circumstances.

  5. When an investigator and/or research personnel disclose an actual or potential conflict of interest, what types of management recommendations may the university impose?

    It is important to remember that cases are individually reviewed, and subtle differences in the nature and magnitude of the financial interest(s), in combination with the investigator and/or research personnel’s role in the research study, the type of research being conducted and the clarity and completeness of the disclosure, all will impact the CIRC’s analysis and recommendations. Some examples include the following:

    Scenario #1: An investigator is hired by an outside entity to perform consulting services and his or her compensation will be relatively modest.

    If an investigator performs personal services for an outside entity with an economic interest in the outcome of research, but the total amount of compensation received is less than $10,000 in the preceding 12 months, the CIRC may simply acknowledge the disclosure and not impose any management recommendations.

    Scenario #2: Same situation as Scenario #1, but the investigator's consulting relationship with the outside entity will result in the receipt of more than $10,000 during a 12-month period.

    Since the investigator will receive more than $10,000 within a 12-month period, the CIRC will more closely scrutinize the disclosure. The CIRC will determine whether the relationship with the outside entity presents a conflict of interest, and if so, how best to manage, reduce or eliminate the conflict through the implementation of an effective management plan.

    Scenario #3: What if an investigator has an ownership interest or managerial responsibilities with a research sponsor?

    These types of financial interests and management roles are considered “significant conflicts” under USC’s Conflict of Interest in Research policy. The CIRC closely scrutinizes such relationships, and only allows the investigator to participate in the research if he or she can present compelling circumstances that support continued involvement.
    The factors considered in determining whether sufficiently compelling circumstances exist include:

    • The extent of the investigator’s equity holdings in the company
    • Whether the investigator is directing the research or, alternatively, has designated another investigator with no financial interest to direct the research
    • Whether the spouse of the investigator is the CEO or other officer
    • Whether the company is a new start-up with no assets or has secured financing
    • Whether the investigator is also serving as a paid consultant to the company
    • The extent to which the research project overlaps with the immediate commercial interests of the sponsor

    Based on the facts of a particular disclosure, the CIRC will determine whether the investigator and/or research personnel can be involved with the research despite the presence of a significant conflict, and if so, require the implementation of an appropriate management plan.
    In addition, since the faculty member’s primary professional duty of loyalty is to USC, a conflict of commitment may be present if the faculty member is devoting significant time to his or her work with the outside entity.

  6. What should an investigator do if his or her conflict of interest changes during the award or contract period?

    The investigator should submit an updated "Statement of Outside Interests Related to Research" for any new or previously undisclosed conflict of interest, particularly when there is a change in personal, financial or fiduciary status. For further information, please see Section 6 of USC’s Conflict of Interest in Research policy.

  7. What resources are available at USC if I have additional questions about conflicts of interest in research?

    There are a variety of resources available to you at USC to help guide you through the process of determining whether you have a potential or actual conflict of interest, and to assist you in making the appropriate disclosure if in fact you do. These resources include the vice provost for research advancement, the Office of Compliance and/or your school’s associate dean for research.