Who determines whether an academic researchers conflict of interest can be managed?
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. Issued: March 1, 2013 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. 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. – 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. 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:
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 disclosedEquity 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:
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 conflictsA 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 permittedCertain types of financial interests and outside activities are not permitted because there is no feasible way to manage the Conflict of Interest. These include:
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 interestAfter 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:
Management plans implemented to mitigate a Conflict of Interest may contain additional measures, including but not limited to:
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. ProceduresN/A 7. ViolationsIt 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. Formshttps://disclose.usc.edu/ 9. Responsibilities
10. Related InformationUSC’s Conflict of Interest in Professional and Business Practices policy Relationships with Industry policy Cooperation with Compliance Investigations policy Faculty Handbook Financial Conflict of Interest — NIH Guidance Conflict of Interest Policies — NSF Grant Policy Manual AAU Guidelines on Managing Conflicts of Interest AAMC Guidelines on Managing Conflicts of Interest Food and Drugs: FDA Guidance on Financial Disclosure by Clinical Investigators USC’s International Collaborations and Export Controls policy 11 ContactsPlease direct any questions regarding this policy to:
Are researchers allowed to have conflict of interest?It is important that researchers involved in human research do not have or appear to have a COI —including a financial interest—related to any of the studies in which they participate.
Which of the following is true about management of conflicts of interest?Which of the following is true about the management of conflicts of interest? Management plans are often created to reduce the impact of conflicts of interest.
What would be considered a conflict of interest in research?A conflict of interest in research occurs when financial or other personal factors affect or appear to impair a researcher's professional judgment in doing or reporting research. The circumstances, not the actions or character of an individual investigator, define a conflict of interest.
Why is conflict of interest problematic in research?Conflicts of interest may be actual, potential or perceived and involve financial and non-financial benefits. Conflicts of interest may affect, or be perceived to affect, a researcher's impartiality and judgement, which can erode confidence in the research.
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