Institutional Review Board > Policies and Procedures > Conflict of Interest

Conflict of Interest

As defined by the National Institutes of Health, a "conflict of interest" arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee's spouse, minor children, an organization in which the employee serves as officer, director, trustee, partner, or employee, or a person or organization with which the employee is negotiating for prospective or has an arrangement for prospective employment. Conflicts of interest can arise out of the fact that a mission of the university includes faculty consulting and the commercialization of technologies derived from faculty research. However, an individual's actions or decisions cannot be determined by consideration of personal financial gain.

The federal guidelines and the university's policy apply to persons responsible for the design, conduct, or reporting of research. In some cases, undergraduate or graduate students may be responsible for the design, conduct, or reporting of research, such that they are considered to be an investigator under this policy and may be required to complete disclosure statements. In any situation, it is the responsibility of the principal investigator to ensure that students are not diverted from their primary educational mission.

When does conflict of interest occur?

A PI or Co-PI is said to have a conflict of interest whenever that PI or IRB member, his or her spouse, or dependent child falls under any of the following conditions:

  • Is an investigator or sub-investigator on the protocol (IRB members only, not applicable to PIs);
  • If the IRB member, the member's spouse, or dependent children are involved in the conduct of research;
  • Has entered into a financial arrangement with the sponsor or agent of the sponsor, whereby the outcome of the study could influence the value of the economic interest of the investigator;
  • Acts as an officer, director, or agent of the sponsor;
  • Has any equity interest in the sponsor that when aggregated for the investigator or member and the investigator's or member's spouse and dependent children exceeds $10,000 as determined through reference to public prices (e.g., NYSE or NASDAQ), any amount if the value cannot be determined through reference to public prices, or 5% of the equity of the sponsor;
  • Has received payments or other incentives from any sponsor when aggregated for the investigator or member and the investigator's or member's spouse and dependent children that total in excess of $10,000;
  • Has identified him or herself for any other reason as having a conflicting interest.

All investigators are required to disclose any conflicts of interest. In cases of conflict of interest, the IRB will table approval pending review by the University legal staff. Once the University legal staff has made final determination, than the IRB shall review the human subject research proposal in accordance with the Common Rule, and to determine whether the PI has made a compelling reason to conduct research in question.