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Investigator Conflicts of Interest

Summary

The University has legal and ethical responsibilities to review and, where appropriate, to reduce, eliminate, or manage potential financial conflicts of interest in research involving human subjects. To ensure that the safety of research participants is adequately protected, UNR

1. Requires reporting and review of significant financial interests that might present a real or potential conflict of interest with the individual's research prior to final IRB approval of the research, and
2. Limits the participation of individuals who hold significant financial interests related to a research project involving human subjects in that research.

Background

According to the National Institutes of Health, a potential financial conflict of interest exists when an investigator has significant financial interests that could lead an independent observer to reasonably question whether the design, conduct, or reporting of research might be influenced by the possibility of personal gain to the individual or his or her immediate family. Financial conflicts of interest can contribute to bias in research reporting, influence judgment, reduce free exchange of research findings, pose a threat to research integrity, and compromise the protection of human subjects. Potential financial conflicts of interest in human subjects research warrant careful scrutiny to ensure that the safety of research participants is adequately protected.

COI Reporting

PIs, Co-PIs, and other key personnel on human subjects protocols reviewed by an IRB have an obligation to report all significant financial interests held by themselves or their immediate families in business entities with financial interests that would reasonably appear to be affected by the conduct or outcome of the human subjects research reviewed by the IRB. University employees typically report significant financial interests in annual disclosure form and a consulting activity form.

COI Review and Management

The campus COI Committee determines whether any disclosed relationships pose the potential for financial conflicts of interest. The COI Committee evaluates the magnitude of any potential conflicts, and it determines what management conditions, if any, need to be put in place to appropriately reduce, eliminate, or manage any financial conflict of interest issues. COI Committee has a key role in assessing financial conflicts of interest for personnel involved in the conduct of human subjects research, IRBs have the ultimate responsibility and authority to evaluate how any particular financial conflict of interest affects a specific human subjects research protocol. When approving any research protocol, IRBs may impose terms, conditions, limitations, or other management elements in the human subjects research protocol to manage a potential or actual financial conflict of interest in addition to those imposed by the COI Committee (the IRB may not overturn any conditions the COI Committee places on investigators). Additional conditions required by the IRB may include disclosure during the consent process, limitations on the role of personnel in the recruitment and/or consent process, or independent monitoring of study data.

Definitions

Business entity:

Any corporation, partnership, proprietorship, firm, enterprise, franchise, association, trust, or legal entity other than an individual or body politic. This term also includes any entity acting as the agent of a business entity (e.g., a contract research organization).

Minimal risk:

The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Significant financial interests:

These include the interests of an investigator (and/or his or her immediate family) or a business entity controlled or directed by the investigator or a member of his or her immediate family, such as consulting fees in excess of $5,000 per annum, equity interests in non-publicly traded business entities, and equity interests in publicly-traded financially interested business entities in excess of the threshold.