The integrity of research and the public’s faith in the research enterprise depends on the disclosure and management of conflicts of interest when present. It is important to note that our concern goes beyond genuine conflicts of interest and includes the potential for that appearance of such a conflict.

When research involves human subjects, it is possible that some subjects would decline to participate in research if they believe that the investigators may personally benefit from the research and may, therefore, have some incentive to manipulate the results of the research. For example, this may happen when an investigator (or a close family member of an investigator) has an ownership interest in, or a consulting relationship with, a company that expects to market a product pending the results of the research. Other examples of potential conflicts include:

  • When investigators conduct applied or clinical research on a technology developed by the investigator or a member of his/her immediate family
  • When investigators (or immediate family members) have a financial relationship with the sponsor of the research
  • When investigators (or immediate family members) own shares of stock, stock options, or other interests in a business that will benefit from the success of the research
  • When investigators (or immediate family members) receive royalties from the marketing of a drug, device, or technology that is the subject of the research
  • When investigators receive payments from a sponsor for recruiting research subjects

Conflicts do not arise simply because the successful completion of the research may result in a conference presentation or publication for the investigators. This is true even if the investigators receive royalties from the publication of the research or receive honoraria or travel assistance associated with invited lectures based on the research.

COI Consent Language

Examples of content language to describe a conflict of interest include:

  • A researcher(s) (family member, etc.) involved in the conduct of this study has (have) a financial interest in the success of the research. This research has the potential to demonstrate the effectiveness of [a medical device, etc.]. If the researcher(s) is (are) able to demonstrate the value of [the device], he/she/they could benefit from the marketing and sale of [the device]. You may see potential for financial gain as a reason to decline to participate in this study.
  • An [external sponsor, corporation name] is paying the researchers to conduct this study. Thus, the [external sponsor] has a financial stake and the researchers have a financial interest in the success of this study. You may see this as a reason to decline to participate in this study.