The FDA looks at the possibility of financial conflicts of interest (COI) in clinical studies. It requires applicants to submit documentation to reveal potential financial conflicts in order to prevent racketeering.
The FDA reviews the financial interests related to a particular research study and decides whether a conflict exists. One example, given by the FDA, describes a situation in which an individual wants to participate in the testing of a medical device for regulating arrhythmic heartbeats. The individual has been appointed to a committee that evaluates the safety of the device, and he is also a researcher at a major university.
The company that created the device has an agreement with the researcher’s university for the testing of another device, but it is unclear whether this secondary contract with the university will be affected by the first device’s review. Hence, the researcher cannot participate in the committee’s deliberations because of the possible financial implications for the researcher and his employer.
Many sponsors are clear about their conditions for COI disclosures. Institutional conflicts of interest sometimes appear between the university and its employee or student, when the institution could financially benefit from a situation. An ICOI committee determines whether a conflict exists. An example of an institutional conflict could be financial interests that affect research integrity, university sources, or other related educational activities.
Individual conflicts of interest occur when a person who serves the advisory committee has a financial interest that could affect the individual’s work in the committee. To determine if a financial conflict exists, the advisory committee completes a special form that aims to identify the potential conflicts by studying a list of the financial interests that could create a conflict. The FDA also identifies entities that can be affected by the outcome of the advisory committee proceedings.
Applicants are required to complete documentation that includes financial disclosures intended to reveal the possible conflicts of interest of the researcher. The purpose of such an application is to prevent racketeering by ensuring that an organization does not hide earned income if the clinical research is successful.