2,051: Policy on Institutional Conflict of Interest in Research Involving Human Subjects
Revised: June 2021
Policy Purpose and Scope
An institutional conflict of interest (Institutional COI) is a situation in which the financial interests of an institution or an institutional official, acting within his or her authority on behalf of the institution, may compromise or appear to compromise, the integrity of research, education, clinical care, business transactions or other activities of the institution. Institutional COIs are of significant concern when financial interests create the potential for inappropriate influence on research involving human subjects.
This policy is established to ensure that the significant financial interests of the University, and of its institutional officials, do not compromise the integrity of research involving human subjects conducted at or under the auspices of the University.
This policy applies to all human subjects research conducted at or under the auspices of the University. This policy does not eliminate University employee obligations for disclosure and/or management of significant financial interests that are required by other University policies and procedures.
Any group, organization or legal entity (e.g., corporation, partnership, sole proprietorship, firm, trust, joint venture, etc.) that is not part of the University of Nevada, Reno.
Institutional Conflict of Interest (Institutional COI)
An Institutional conflict of interest (ICOI) means a situation in which the significant financial interests of the University, or of an Institutional Official who has authority to act on behalf of the University, might compromise – or reasonably appear to compromise – the integrity of the design, conduct, reporting, review or oversight of human subjects research.
Human Subjects Research
For the purposes of this policy, human subjects research includes, but is not limited to, basic, applied, and clinical research projects or programs conducted at or under the auspices of the University that require approval by the University’s Institutional Review Board (IRB). Exempt human subjects research may be reviewed for Institutional COI on a case-by-case basis.
For the purposes of this policy, an Institutional Official is anyone who i) has oversight and/or decision-making authority over faculty appointments, salaries, promotions and/or the allocation of resources, such as assignment of graduate students or other trainees, funding or space, for faculty who are conducting human subjects research at or under the auspices of the University; ii) anyone who has the authority to enter into an agreement with an external entity on behalf of the University for the conduct of human subjects research; or iii) any other individual so designated by the President.
Significant Financial Interest (Individual)
For Institutional Officials, significant financial interest is defined in the University’s conflict of interest policy. The significant financial interests of Institutional Officials will be reviewed from their COI disclosures; this policy does not require additional COI disclosures from Institutional Officials.
Significant Financial Interest (Institutional)
For the purposes of this policy, an institutional financial interest is significant when it meets or exceeds the applicable threshold for each specific category of financial interest, as established by the Institutional Conflict of Interest Committee.
The following significant financial interests of the University warrant review for potential Institutional COI with respect to non-exempt human subjects research. For the purposes of this policy, University financial interests include those held by the University as well as those held by another entity on behalf of the University (e.g., the Nevada Research and Innovation Corporation).
- Royalties: Agreements to receive milestone payments and/or royalties from commercialization of a product or technology that is the subject of the research.
- Non-publicly traded equity: Equity interest or entitlement to equity of any value (including options or warrants) in a non-publicly traded company that: i) is the sponsor of the research; ii) owns or controls products being studied, tested or evaluated; or iii) could materially benefit from the research.
- Publicly traded equity: Equity interest or an entitlement to equity (including options and warrants) in a publicly traded company, the value of which meets or exceeds the threshold set by the Institutional Conflict of Interest Committee, that: i) is the sponsor of the research; ii) owns or controls products being studied, tested or evaluated; or iii) could materially benefit from the research.
- Gifts: Gifts (including restricted, unrestricted and gifts in kind) that meet or exceed the threshold set by the Institutional Conflict of Interest Committee, from i) a sponsor of the research; ii) a company that owns or controls products being studied, tested or evaluated; iii) a company that could materially benefit from the research; or iv) an individual affiliated with such a company.
- Other: Other financial interests of the University or its Institutional Officials, as determined by the President.
The Office of the President is responsible for the administration of this policy. The President or designee shall:
- form an Institutional Conflict of Interest Committee (Institutional COIC) as described in the following section;
- review and approve plans submitted by the Institutional COIC to manage, reduce, or eliminate Institutional COIs;
- ensure that individuals who act on behalf of the University adhere to these policies and procedures; and
- determine appropriate actions in response to violations of this policy.
Institutional Conflict of Interest Committee (Institutional COIC)
An Institutional Conflict of Interest Committee (Institutional COIC) shall be formed to:
- establish significant thresholds for University financial interests;
- create procedures for compliance with this Institutional COI policy;
- review potential Institutional COI situations to determine whether they are manageable,
- when appropriate, recommend actions to manage, reduce or eliminate risk so that the research may proceed;
- identify situations that are not manageable;
- coordinate with the IRB and communicate its determinations and management plans; and
- respond to other requests from the President or designee.
The Institutional COIC will be advisory to the President, who holds final authority regarding Institutional COI situations.
The Institutional COIC members must have sufficient expertise, seniority and independence. General Counsel shall serve as legal advisor to the Institutional COIC. The University’s Conflict of Interest Designated Official shall assist the Institutional COIC and attend all meetings. The Director of Research Integrity, or their designee, may attend meetings at their discretion. To the extent that the Institutional COIC requires specialized clinical, scientific or other knowledge to make its determinations, it will seek such input from individuals with appropriate expertise, either from the University or outside the institution.
No member of the Institutional COIC may participate in the review of research in which that member has a significant interest with a business entity that could benefit from the research, except to provide information requested by the Institutional COIC. Members of the Institutional COIC are expected to disclose any financial interest which may be related to the review of research.
The Institutional COIC shall meet as necessary to review Institutional COI issues, and maintain a record of its deliberations and actions.
Management of Institutional Conflicts of Interest Involving Human Research Subjects
If the Institutional COIC determines that an actual or perceived Institutional COI situation exists, the Institutional COIC will recommend one of the following recommendations:
- The research may proceed, subject to an Institutional COI management plan to mitigate the risks associated with the Institutional COI; or
- The Institutional COI situation is not manageable, and the University must choose either to retain its significant financial interest and to decline the research, or to eliminate the significant financial interest and proceed with the research.
A management plan may impose any condition and prescribe any action necessary to manage an Institutional COI to ensure that the research is free from bias or even the appearance of bias. A management plan must be in the form of a written agreement and must be signed by all parties involved.
Institutional COI management plans do not replace individual investigator COI management plans. The Institutional COIC will work in collaboration with the University’s Conflict of Interest Designated Official to assure that there is no overlap or duplication with individual COI management plans.
The final decision whether to proceed with University support and regulatory review will be made by the University President or designee. If approved to proceed to regulatory review, the research may not proceed without a fully signed management plan and IRB approval.
Implementation and Monitoring
Each Institutional COI Management Plan should state specifically who will be responsible for the plan’s implementation and monitoring. Compliance with the terms of the plan must be reviewed at least annually. The Institutional COI Management Plan shall stay in effect until the Institutional COIC determines that it is no longer necessary.
Allegations of violation of this policy, including disclosure requirements and violations of an Institutional COI management plan, should be presented to the chair of the Institutional COIC. The Institutional COIC chair shall promptly investigate the allegations. At the conclusion of the investigation, the Institutional COIC chair shall report the findings and recommendations to the University President. If warranted, administrative or disciplinary action will be determined by the President in accordance with relevant state, NSHE and University policies.