Conflicts of Interest (COI) in Research

What Is a COI and How Is It Managed? 

The term “conflict of interest (COI) in research” refers to situations in which financial or other personal considerations may compromise — or have the appearance of compromising — an investigator’s professional judgment in conducting or reporting research. A COI depends on the situation and not on the actions or character of an individual investigator.

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.

Federal regulations, state laws and University policies require that faculty members submit financial disclosure forms at the time that a proposal is submitted for funding. When a financial interest and possible COI is disclosed, the case is reviewed by an independent review committee, the Chancellor’s Conflict of Interest Advisory Committee (COIAC).

The COIAC and IRB will coordinate with the PI to ensure the study incorporates the COIAC's recommendations to manage a potential COI.

IRB Application Procedures

The IRB Application asks you to respond “yes” or “no” to the following statement: "Do you [the PI] or any other responsible personnel (or the spouse, registered domestic partner and/or dependent children thereof) have financial interests related to this study?" Additional information on financial interests is available on the COIAC website.

If the answer is "yes," take the following two actions:

  • Keep all financial interest disclosures current with the COIAC office. The COIAC Office may contact you for additional information.
  • Briefly describe this financial interest in the consent form. See the sample wording below.

Recommended Consent Form Language

Informed consent documents for UC research projects require that “(a) a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment; and (b) a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of confidentiality.”

Briefly describe the following info in the "Why is this study being done?" or "What are the costs?" section of the consent form:

  • Funder: Disclose which agencies or institutions, cooperative groups, foundations or industry sponsors are funding the research or providing study drugs or equipment for the study. If the study is not being funded by an external agency, then identify the internal funding source (i.e., department funds, personal funds). 
  • Financial or proprietary interests: Also disclose the nature of any financial or proprietary interests, though this disclosure can be in general terms.

Avoidance of IRB Member or Consultant COI

It is important that the members or expert consultants of the IRB do not have or appear to have a COI related to any of the studies in which they participate in the review process. 

An IRB member is provided guidelines for considering the actual or potential COI, and also determining whether a particular role or relationship could affect his or her objectivity before reviewing, participating in the panel discussion or deliberation, and voting on a protocol. Members who have a COI on a particular protocol are required to recuse themselves from reviewing or voting on a particular protocol. Procedures are in place to make sure that this occurs at every meeting and for the review of every study.

Last updated: June 3, 2021