Conflict of Interest in Research – Policies and Policy Governance

Applies to: Faculty (including part-time and visiting faculty), postdoctoral scholars, academic staff, 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 who are on sabbatical or other leaves, or who are visiting other institutions.

1. POLICY

Issued: March 1, 2013
Last Revised: October 14, 2022
Last Reviewed: October 14, 2022

2. Policy Purpose

The purpose of this policy is to promote the highest ethical standards in situations where conflicts of interest may occur in the conduct of research.

The University of Southern California (“USC”) encourages its faculty, staff, and students to participate in meaningful professional relationships with industrial and other private partners. These partnerships are established for mutually beneficial reasons and many times produce knowledge and technology that will help to meet societal needs.

In certain circumstances, relationships with outside interests can create, or appear to create conflicts of interest or situations where competing interests can conflict. While having a conflict of interest does not imply wrongdoing or inappropriate activity, conflicts do require review and management to ensure that the conflict does not improperly influence, or appear to improperly influence, how USC research is proposed, conducted, or reported. Transparency is the cornerstone of effective conflict oversight and management. Many times, disclosure itself minimizes a perception of bias in the conduct of research. It is therefore critical that all conflicts be disclosed promptly, fully, and thoroughly, in advance, in the manner provided in this policy. This policy explains the process for identifying and disclosing conflicts and the methods by which they are managed by the university.

3. Scope and Application

This 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 when there is an actual or apparent conflict of interest before they receive a written determination from the Vice President of Research as to how to manage the conflict.

Special care must also be taken when students or trainees are involved with research where an actual or apparent conflict of interest exists so that academic progress is not impeded or affected by a faculty member or supervisor’s conflict of interest.

4. Definitions

Term	Definition
Close Relation	Spouse, domestic partner, intimate partner, or dependent child of an investigator or research personnel.Please note that this definition follows the National Institute of Health definition and differs from the definition under the Conflict of Interest and Commitment policy.
Conflict of Commitment	Arises when a USC Employee undertakes a role (paid or unpaid) outside of USC that interferes, appears to interfere, or has the potential to interfere with the USC Employee’s ability to perform core job responsibilities and commitments to USC.
Conflict of Interest	The term Conflict of Interest encompasses both Conflicts of Interest and Conflicts of Commitment. A Conflict of Interest arises when: – Professional, financial, or personal activities or relationships compromise, or have the appearance of compromising, a USC Employee’s professional loyalty and responsibility to USC, and ability to perform USC duties and responsibilities in a full and complete manner. – A USC Employee’s professional, financial, or personal activities compete, or have the appearance of competing, with the university. See sections Prohibited Conflicts of Interest and Outside Activities and Conflict of Commitment.
Conflict of Interest in Research	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 duties to maintain research objectivity. Investigators should not only consider situations that are set forth in this policy, but also gray areas that might create the appearance of a conflict of interest.
Conflict of Interest Review Committee (“CIRC”)	The CIRC, chaired by the Vice President of Research (VPR) or their designee, is charged with reviewing conflict of interest disclosures and formulating recommendations to manage, reduce, or eliminate conflicts of interest. The CIRC consists of faculty members appointed by the Vice President of Research, a representative from the Office of Culture, Ethics and Compliance, a representative from the USC Stevens Center for Innovation (non-voting), a representative from the Institutional Review Board (IRB) or the Office for Protection of Research Subjects (OPRS), an attorney from the Office of General Counsel (non-voting), a representative from the Department of Contracts and Grants (non-voting), and such other representatives as may be determined by the CIRC.
Consulting	Consulting activity involves payment for services rendered to an outside entity. Consulting payments do not include research payments to USC intended to support research projects taking place at USC.
diSClose	USC’s on-line disclosure system which is used to submit annual disclosures, conflicts of interest in research, personal conflicts, conflicts of commitment, and financial conflicts.
Equity interest	An equity interest includes stocks, stock options, or other ownership interests in a company that either sponsors the investigator’s research or may benefit economically from its outcome (e.g., a company that is a licensee of intellectual property under study).
Institutional Responsibilities	An investigator’s professional responsibilities on behalf of the institution including, but not limited to, activities such as research, teaching, professional or clinical practice, institutional committee memberships, and service on panels such as Institutional Review Boards (IRBs) or Data Safety and Monitoring Boards.
Investigator	The principal investigator, co-principal investigator, contact principal investigator, or co-investigator. Other persons are regarded as investigators if they have independent responsibility for some aspect of the design, conduct, or reporting of research.
Management Roles	A management role is one where the investigator, research personnel, or close relation maintains significant decision-making authority in an outside entity that is either: (1) a research sponsor or (2) may benefit economically from the outcome of the research. Examples of management roles with significant decision-making authority include chief scientific officer, board member, founder, or any similar role.
Research	A systematic investigation designed to develop or contribute to generalizable knowledge, including biomedical, behavioral and social-sciences research or other scholarly activity, whether or not it is funded.
Research Personnel	Any other USC faculty member (including part-time and visiting faculty), staff, other employees, and students (including postdoctoral fellows) who contribute to a research activity, whether or not the research is funded, and regardless of employment status (e.g., research associates, technicians, nurse coordinators, administrators, graduate assistants).
Significant Conflict of Interest	A significant conflict of interest is a conflict whose potential for actual or perceived bias is great enough that the investigator or research personnel must present compelling circumstances as to why the research should proceed despite the presence of the conflict. A significant conflict exists in the following situations: Equity interests in a privately held research sponsor, unless the investigator provides verification that the equity interest is less than 10% of the outstanding stock or non-stock ownership share of the sponsor. Publicly traded equity interests in excess of $50,000 in a research sponsor, except when the interest is maintained in an investment vehicle where the investigator or research personnel does not directly control the investment decisions made (e.g., mutual fund).Management role in a research sponsor or entity with a financial interest in the research. Receipt of payment for services (including payments related to promoting, marketing, or selling products) on behalf of a company for whom the investigator has also conducted research as an independent evaluator of the company’s products. In the case of human subjects research, a significant conflict also exists for the following financial interests and outside activities in addition to the ones specified above: Receipt of consulting payments that total $25,000 or more in any twelve-month period from a sponsor or a company that may benefit economically from the outcome of the research. Private equity interests regardless of value.
Student or Trainee Conflict of Interest	A student or trainee conflict of interest exists when a researcher has a financial interest in a company and retains a student or post-doc to provide services (paid or unpaid) that could benefit the company and any one of the following apply:The student is currently enrolled in the class of an investigator, research personnel, or close relation.The investigator, research personnel or close relation supervises the student in an academic capacity.The investigator, research personnel or close relation can influence the academic progress of the student.The investigator, research personnel or close relation otherwise supervises the student or trainee as a research assistant or employee.

5. Policy Details

5.1 General Principles

Investigators and research personnel are responsible for identifying and disclosing Conflicts of Interest covered by this policy. Investigators and/or research personnel should evaluate potential conflicts of interest on an ongoing basis and disclose, promptly and in advance, financial interests and outside activities giving rise to a Conflict of Interest. This responsibility arises when a new proposal is submitted; a new relationship is established with an outside entity; or when a prior relationship with an outside entity changes.

If a Conflict of Interest is above certain financial thresholds or involves human subjects research it is considered a Significant Conflict of Interest. In the case of a Significant Conflict of Interest, the investigator or research personnel must present compelling circumstances as to why the research should proceed. This determination 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.

If a Conflict of Interest is found to be manageable, the university will require the implementation of a management plan designed to mitigate or eliminate the conflict, as described below. If the university determines that the conflict cannot be effectively mitigated or eliminated through the implementation of a management plan, the research will not be allowed to proceed unless the investigator eliminates the outside interest or activity giving rise to the conflict.

Investigators and research personnel are not permitted to begin any research activity when a Conflict of Interest exists, until they report the conflict and receive a written determination from the Vice President of Research, or their designee, on how to manage it. Investigators and research personnel also are not permitted to begin an external activity that would create a Conflict of Interest until they report the conflict and receive a written determination from the Vice President of Research, or their designee, on how to manage it.

Investigators must submit an annual disclosure of financial interests related to their institutional responsibilities (regardless of whether the interest creates a Conflict of Interest) when mandated by a research sponsor (e.g., the Department of Health and Human Services [HHS], Department of Energy), in accordance with the schedule established by the university. The university may also require disclosures at other times. Investigators who have or are seeking support from any sponsors who require an annual disclosure must:

Have a current annual disclosure at the time of proposal submission.
Update their annual disclosures within 30 days of the time they obtain a financial interest with an entity that was not disclosed at the time of the most recent annual disclosure.
Update their disclosure on an annual basis.

Investigators are responsible for confirming that research personnel under their supervision who are involved in proposing, conducting, or reporting research on the investigator’s project identify and disclose any Conflict of Interest.

5.2 Financial interests and outside activities that must be disclosed

Equity interests

If the company is privately held, all equity interests must be disclosed regardless of value. If the company is publicly traded, equity interests of $5000 or more must be disclosed, unless the equity interest is maintained in an investment vehicle (e.g., mutual fund, retirement account) where the investigator, research personnel, or close relation does not directly control investment decisions.

Management roles

A management role is one where the investigator, research personnel, or close relation maintains significant decision-making authority in an outside entity that is either a research sponsor or may benefit economically from the outcome of the research. It also includes acting as a chief scientific officer, board member, founder, or any similar role.

Payments for Services

Payments for services from a research sponsor or an entity that may benefit economically from the outcome of the research that total $5,000 or more when aggregated over a twelve-month period must be disclosed. This includes but is not limited to payments for:

Service on a board, advisory committee, or review panel
Scientific or technical appointments
Payments for lectures and similar public appearances
Honoraria
Paid authorship
Consulting

Sponsored travel

Sponsored travel or reimbursement of expenses associated with travel and provision of services that totals $5,000 or more when aggregated over a 12-month period is also considered a conflict of interest to the extent the sponsorship/reimbursement is not reasonable. Unreasonable sponsored/reimbursed travel includes, but is not limited to, travel paid for or reimbursed for the investigator’s family.

Intellectual property

Personal receipt of intellectual property rights (e.g., share in patents, copyrights or royalties) directly from a research sponsor or a company who may benefit economically from the outcome of the research (e.g., licensee).

Compensated Outside Research

Participation as a principal investigator, co-principal investigator, co-investigator, paid consultant, or paid staff member on sponsored projects at another entity (as distinct from research collaborations with other entities via a subcontract or subaward to USC) must be disclosed to the appropriate dean and the Vice President for Research and are prohibited unless specially approved by the dean and the Vice President for Research or their designee.

Please note that, regardless of the nature of financial interest or covered outside activity, disclosure obligations apply to domestic as well as foreign activities.

5.3 Significant conflicts

A Significant Conflict of Interest requires that the investigator or research personnel present compelling circumstances as to why the research should proceed. If the CIRC concludes that the investigator has presented compelling circumstances, it will implement conflict mitigation requirements, including but not limited to those discussed above. If the CIRC concludes that the investigator has not presented compelling circumstances, the research cannot proceed as proposed.

5.4 Financial interests and outside activities that are not permitted

Certain types of financial interests and outside activities are not permitted because there is no feasible way to manage the Conflict of Interest. These include:

Participating in a paid “speaker’s bureau” (i.e., talks/presentations in which the topic(s) and/or content are provided by the company) for a research sponsor or a company that may benefit economically from the outcome of research.
Incentive payments, bonus payments, finder fees, or any type of payment or incentive based on outcome, where the payment or incentive is made to the researcher or to research personnel relating to the proposal, conduct, supervision, or reporting of research (e.g., additional personal payments to investigators or research personnel who enroll a certain number of participants in a project within a certain period of time), or payment or incentive with respect to the evaluation of a product or service intended for a commercial market.
Accepting personal gifts, gratuities, or special favors from an actual or prospective sponsor of an investigator’s research, other than occasional gifts or nominal or modest value (less than $50 in value or isolated invitations to meals).

Maintaining a financial interest or engaging in an outside activity for a research sponsor who seeks to restrict publication of research results, other than reasonable delays of publication in order to protect proprietary rights (i.e., patent rights). This does not include restrictions on publication for reasons of national security and/or export control, if the requirements of USC’s International Collaborations and Export Controls policy are followed.

5.5 Standards of review applicable to disclosed conflicts of interest

After a financial interest or outside activity related to research is disclosed, the university reviews the disclosure on a case-by-case basis to determine whether the disclosure constitutes a Conflict of Interest, and if so, how to appropriately mitigate the Conflict of Interest in a way that preserves the integrity and objectivity of the research. Faculty must keep in mind that certain financial interests and outside activities may create a Conflict of Interest that cannot be effectively mitigated or managed.

Required elements of conflict management

All management plans implemented to mitigate Conflicts of Interest will contain, at minimum, the following elements:

All relevant publications, proposals, and presentations must contain a statement disclosing support received from, or financial interests in, any source outside of USC.
All informed consent documents in the context of human subjects research must disclose support received from, or financial interests in, any source outside USC. Conflicted investigators are not permitted to consent human subjects.
The investigator and/or research personnel and their close relations will not represent the university in any intellectual property or other contractual negotiations between USC and the outside entity.
Investigators must notify students of the presence of a Conflict of Interest if students are to perform as research assistant or research staff on the research, along with a notification to the students and their advisors of the student’s rights. In order to protect student rights, the university may appoint a third-party monitor (e.g., faculty member, the Graduate School) to ensure the student is making timely progress towards degree objectives and that the student’s rights are otherwise protected.

Management plans implemented to mitigate a Conflict of Interest may contain additional measures, including but not limited to:

Recusal of the conflicted individual from data collection and/or data analysis for the relevant research project
Referral to a supervisor or independent individual approved by the CIRC for monitoring or oversight.
Reduction of involvement or role for the conflicted individual for the relevant research project
Termination of student involvement in the research project or appointment of an independent monitor
Removal of the conflicted individual from the research project.
Divestiture of relevant financial interests
Severance of outside activities that pose a conflict of interest.

Additional review

In cases where a Conflict of Interest disclosure also reveals a conflict of commitment, an additional review must also be undertaken as specified in the Conflict of Interest and Commitment policy applicable to all university employees.

6. Procedures

Conflict of Interest in Research Procedures

7. Violations

It is serious misconduct or neglect of duty for any individual subject to this policy to fail to observe any of its requirements, including but not limited to failure to make full disclosure through diSClose promptly, fully, and in advance; failure to observe the terms of a management plan; or engaging in a prohibited activity. Findings of violation by the appropriate CIRC will be referred for consideration of sanctions or corrective action according to the Faculty Handbook, Student Handbook, or staff policies.

8. Forms

https://disclose.usc.edu/

9. Responsibilities

POSITION or OFFICE	RESPONSIBILITIES
USC Employees	Identify and report potential Conflicts of Interest to the Office of Culture Ethics and Compliance using diSClose. Obtain necessary approval on reported Conflicts of Interest in Research and adhere to management of 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 conflict of interest disclosures and formulating recommendations to manage, reduce, or eliminate conflicts of interest. The recommendations are then presented for approval to the Office of Research.
Office of Culture, 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.