Investigator Conflicts of Interest

IRB Member Fact Sheet--Version Date: Unknown

The University of Wisconsin Madison (UW-Madison) 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, the UW-Madison (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.

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.

Application of the Campus COI Policy
The UW-Madison COI policy applies to all principal investigators (PIs), co-investigators (Co-PIs), and other key personnel on human subjects protocols reviewed by UW-Madison IRBs who are (a) UW-Madison employees, (b) UW-Madison students, or (c) other project personnel, regardless of their relationship with UW-Madison, when they or their immediate families have personal financial interests in business entities and whose situations are not reviewed and managed by another institution with respect to potential financial conflicts of interest related to the protocol in question

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 a UW-Madison IRB. UW-Madison employees typically report significant financial interests in Annual Outside Activities Reports.

For all IRB applications, the PI also must:
  • Identify all research sponsors
  • Identify all business entities owning or licensing any technologies being tested in the proposed study
  • Identify any additional business entities involved in or potentially affected by the research project
  • Name PIs, Co-PIs, or other project personnel who
    • have significant financial interests in any business entity sponsoring the study
    • have significant financial interests in any business entity that owns or licenses a technology tested in the study
    • have any proprietary interests (royalties, patents, trademarks, copyrights, or licensing agreements) involving any technologies being evaluated as part of the study
    • receive personal incentives for recruiting human subjects or for any other purpose directly related to the study
  • Submit protocol-specific Outside Activities Reports for any individuals who are not required to file annual Outside Activities Reports under the policy or other University policies. These reports must be submitted before an IRB will grant final approval to a protocol application.
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. Research participation is restricted when individuals have a significant financial interest in the entity or entities that meets or exceeds one of the following thresholds:
  • Compensation of $20,000 or more in a calendar year from a business entity
  • An ownership interest in a publicly traded business entity valued at $20,000 or more or a 5% or greater equity interest 
  • An ownership interest in a privately held business entity 
  • A leadership position in a business entity (Leadership positions are positions with fiduciary responsibility, including senior managers (e.g. presidents, vice presidents, etc.) and members of boards of directors. Scientific advisory board membership is not a leadership position.)
Although the campus 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.

Exceptions to COI Management Plans
In some cases, investigators may qualify for an exception to management plans issued by the COI Committee. The exception process depends on the risk level of the proposed research. If a UW-Madison IRB determines that a study poses no greater than minimal risks to subjects, investigators will normally be granted an exception to this prohibition without COI Committee review, unless a UW-Madison IRB determines that the investigator must apply to the COI Committee for an exception. For all other protocols, individuals must apply to the COI Committee for exceptions in writing.

The COI Committee only grants exceptions for protocols that pose greater than minimal risks to subjects in very rare circumstances. For example, the COI Committee might grant an exception if an individual is uniquely qualified by virtue of expertise or experience to participate in the research and the research could not be conducted as safely or effectively without the individual.

If the COI Committee grants an exception for any particular protocol, the PI must provide the following information to human subjects research participants:
  • the role(s) of the managed business entity in the study
  • the nature of the relationship(s) between the managed business entity and all study personnel
Anyone with an exception must also inform all PIs and Co-PIs of the protocol that the COI Committee has granted him or her an exception so that he or she may participate in the project. The COI Committee may recommend that the IRB require additional modifications to the protocol to reduce, eliminate, or manage conflict situations (e.g., require a data and safety monitoring board, restrict the roles of particular study personnel).

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 $10,000 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. See UW-Madison policy for a complete list.

Further Information
For further information about investigator conflicts of interest, please consult the Conflict of Interest website:

Keywords:IRBM, coi   Doc ID:19232
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-07-21 19:00 CDTUpdated:2015-10-19 11:37 CDT
Sites:Health Sciences IRBs
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