1. Policy
Issued: 9/1/2009
Last Revised: 5/7/2025
Last Reviewed: 5/7/2025
Applies to: Faculty (including part-time and visiting faculty), postdoctoral scholars, staff and students (including graduate/undergraduate student workers and graduate assistants) employed by University of Southern California and its subsidiaries including Keck Medicine of USC (“USC employees”). This policy continues to apply to individuals on sabbatical, other leaves or while visiting other institutions.
2. Purpose
The University of Southern California (“USC” or the “University”) encourages its faculty, staff, and students to participate in meaningful research and to benefit society through the transfer of university-developed knowledge to the public and private sector. The university’s research will be conducted with integrity and objectivity, and in a manner that protects the safety of human subjects. As set forth in this policy, the university is also committed to ensuring that its own financial interests do not create an ICOI that might bias research conducted by its faculty, students and staff.
The objective of this policy is to promote the highest ethical standards in the conduct of research in situations where institutional conflicts of interest (“ICOI”) may occur, and to determine those instances when an ICOI is unacceptable. An ICOI may occur when a financial interest of the university (e.g., investments held by the university in a company) has the potential to bias research conducted by its employees or students, or creates an unacceptable risk to human subjects.
This policy represents one aspect of the university’s commitment to address and manage conflicts of interest. Other university policies that address conflicts of interest include:
- The university’s Financial Conflict of Interest in Research policy addresses conflicts of interest that arise from individual financial interests related to research.
- The university’s Conflict of Interest and Commitment policy addresses individual conflicts of interest with respect to Employment and Business Practices, Conflict of Commitment, and Personal Conflict of Interest, and requires that university employees not allow a personal or outside interest to interfere with their duties and responsibilities to the university.
- The university’s policy on Relationships with Industry addresses consulting and service arrangements, receipt of gifts, and the conduct of research sponsored by pharmaceutical companies, medical device companies, health care suppliers, and their employees or agents.
3. Scope and Application
his policy applies to all university faculty members (including part-time and visiting faculty), staff and other employees, and students (including postdoctoral fellows) who propose, conduct, or report research on behalf of the university, regardless of funding source. This policy applies to all sponsored projects, including government and non-government funded projects (such as industry or foundation sponsors), university funded projects, gift funded projects, clinical trials, and also to unfunded research projects.
Investigators are not permitted to begin any research activity until they have disclosed any institutional conflicts of interest in research and have received a written determination from the Senior Vice President of Research and Innovation (SVPRI) as to how to manage the conflict.
4. Definitions
| Term | Definition |
| Research | A systematic investigation designed to develop or contribute to generalizable knowledge, including biomedical, behavioral and social-sciences research or other scholarly activity in any discipline, whether or not it is funded. |
| Human subject | A human subject is a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. |
| Outside entity | Any organization (including for-profit or not-for-profit and whether incorporated or otherwise) that is not owned or controlled by the university, or any individual that is not employed or otherwise affiliated with the university. |
| Institutional Conflict of Interest | An Institutional Conflict of Interest exists when the financial interests of the university have the potential to cause bias in the conduct of research. Such conflicts occur most frequently in situations where a research project provides a direct benefit to an outside entity through evaluation, validation, trial or test of an invention, product, drug, service or technology, and the university holds a financial interest in the outside entity. For purposes of this policy, a university-held financial interest in an outside entity includes, but is not limited to, receipt of royalties from the outside entity or an ownership interest in the outside entity. |
| Significant Institutional Conflict of Interest | An ICOI is deemed a “Significant Conflict” when a research project includes human subjects and any of the following conditions applies: The university holds any private equity in the outside entity, or The university has the potential to receive cash payments from existing licensing arrangements with the outside entity; or The university maintains an ownership interest or an entitlement to equity in a publicly-traded sponsor of human subject research as a result of technology licensing activities. |
5. Policy Details
All ICOIs that do not present a Significant Institutional Conflict of Interest shall be managed by disclosing the university’s relationship with the outside entity in all relevant publications, proposals, consent documents and presentations. The requirement of such disclosure is limited to those circumstances where the investigator knows or has reason to know of the university’s relationship with the outside entity.
Significant Institutional Conflicts of Interest are presumed to be unacceptable, unless compelling circumstances are present that justify allowing the research to proceed at the university despite the presence of a significant conflict. Evaluation of compelling circumstances will based on these considerations:
- Nature of the research, current phase of development and intentions for subsequent phases.
- Magnitude of potential risks to human subjects inherent in the research, and how those risks could be affected as a result of the ICOI.
- Degree to which university and its employees stand to benefit financially from the research.
- USC’s financial and/or reputation risk relative to potential benefit of research.
- Likelihood that a societally important development project will be substantially impeded if the research is not performed at USC.
- Societal impact of successful development, relative to potential risk to the university.
- Magnitude of potential risks posed to students engaged in the research project.
5.1 Notification: As soon as any university department, regulatory oversight committee, faculty member, staff employee or student becomes aware of a potential ICOI, he or she must notify the Office of Ethics and Compliance (OEC). In particular, the USC Stevens Center for Innovation will notify OEC in any instance where the university has taken, or intends to take, equity in an outside entity related to USC’s intellectual property, or will receive royalty income related to USC’s intellectual property.
5.2 Assessment
OEC will make an initial assessment of whether an ICOI exists, and then take the following actions:
- If OEC determines that an ICOI exists, but is not a Significant ICOI, the investigator will be instructed on how to disclose the university’s relationship in all publications, proposals, consent documents and presentations.
- If OEC determines that the ICOI is a Significant ICOI, the investigator will be given the opportunity to provide a detailed written explanation of compelling circumstances as to why the research should proceed for review.
- If it is determined that no ICOI exists, the disclosing party will be notified that no action is needed.
5.3 Explaining Compelling Circumstances:
If an investigator believes that a research project should be conducted within the university, despite the presence of a Significant ICOI, he or she should provide a detailed written explanation of the compelling circumstances to the Vice President of Research, addressing the criteria noted above. This explanation must also include the steps taken to secure an alternate research site outside of the university, and the justification for why the alternate research site is inadequate.
5.4 Assessment and Determination:
The investigator’s disclosure will be reviewed under the associated procedures and will incorporate review from outside of USC.
The University Conflict of Interest Review Committee (CIRC) will review the disclosure and any outside review and make a recommendation to the Vice President of Research and Innovation. Their recommendation shall take into consideration any personal conflicts of interest of individual investigators, which must be separately disclosed under the Financial Conflict of Interest in Research Policy. The CIRC’s recommendations may include:
- Prohibiting the research from taking place at USC,
- Permitting the research to proceed, subject to a plan for managing the ICOI and any personal conflicts of interest,
- Permitting the research to proceed coupled with divestiture of financial interests of the university and individual investigators.
The CIRC will communicate its recommendations, which are advisory, to the Vice President of Research and Innovation for final determination. The Vice President of Research and Innovation’s decision will be communicated to the relevant IRB, USC Stevens, the dean or department chair in the school where the research is taking place, and other stakeholders as applicable, as applicable. If the research is permitted to proceed at USC, the decision should document the compelling circumstances, and document the plan used to manage the ICOI. The IRB may elect to implement additional safeguards for the protection of human subjects.
6. Procedures
Institutional Conflict of Interest Procedures
Recusal
As set forth in the university’s policy on Conflict of Interest and Commitment, any person in a position of authority, including department chair, center or institute director, dean, Vice President of Research or Provost, who has a direct financial interest in the outcome of a research project under his or her authority, shall recuse him or herself from any decision pertaining to either an institutional or personal conflict of interest in research, or pertaining to any level of oversight over the research project. In case of recusal, a substitute person will be designated by the dean, provost or president to act in place of the recused individual.
Violations and Sanctions
Failure to report a Conflict of Interest, or refusal to cooperate in the management of a Conflict of Interest, may be cause for disciplinary action. Possible violations of this policy include, but are not limited to, furnishing false, misleading, or incomplete information.
Sanctions for violations of this policy for faculty will be in accordance with all applicable provisions of the policies published in the Faculty Handbook.
Sanctions for violations of this policy for students will be in accordance with all applicable provisions of the policies contained in the USC Student Handbook.
Sanctions for violations of this policy for staff or other non-faculty employees will be in accordance with USC policies and practices.
Any disciplinary action under this policy will take into account the scale of the offense, the individual’s intent, and the degree of wrongdoing.
Violations that involve a misrepresentation of research results will be handled according to the university’s Scientific Misconduct policy.
Violations of federal or state statutes and guidelines must be handled according to those requirements.
7. Forms
ICOI Template Disclosure Form
8. Responsibilities
| POSITION or OFFICE | RESPONSIBILITIES |
| USC Employees | Identify and report potential Conflicts of Interest to the Office of Ethics and Compliance using diSClose. Obtain necessary approval on reported Conflicts of Interest in Research and adhere to management of Financial Conflict of Interest in Research plans. Report any material changes in previously reported and approved Conflicts of Interest. Update disclosures promptly upon any changes to the research or financial interests disclosed. |
|  Conflict of Interest Review Committee (CIRC)  | The CIRC is charged with reviewing financial conflicts of interest (FCOI) and formulating recommendations to manage, reduce, or eliminate conflicts of interest. The recommendations are then presented for approval to the Office of Research. The CIRC also assists in the review of SFIs to determine when an SFI creates a FCOI. |
|  Office of Ethics and Compliance  | Provide guidance on requirements and applicability of this policy and the disclosure process. Present disclosures to the CIRC for review. |
| Office of Research | Appoint CIRC committee members. Approve management plans proposed by the CIRC.  |
9. Related Information
USC’s Conflict of Interest and Commitment policy
USC’s Financial Conflict of Interest in Research policy
USC’s Relationships with Industry (RWI) policy
USC’s Cooperation with Compliance Investigations policy
10. Contacts
Please direct any questions regarding this policy to:
| OFFICE | PHONE | |
| Office of Ethics and Compliance | (213) 740-8258 | Compliance@usc.edu |