Study Assessment
Main Content
Financial Disclosure/Conflicts of Interest
Definition
- A conflict of interest is a relationship by which an employee’s or an employee’s family’s personal interest (financial or otherwise) may or may appear to influence or compromise the employee’s professional judgment or ethics.
- Financial disclosure is the submission of information concerning compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies.
Policies/guidelines
- UMMC’s Conflicts of Interest Policy requires employees to disclose any relationships which could reasonably be expected to create the appearance of a conflict of interest. The policy requires completion of a Conflict of Interest Disclosure by all employees at least on an annual basis.
- When a research project is submitted to the Office of Research and Sponsored Programs, Office of Clinical Trials, or Institutional Review Board (IRB), the investigator will be asked to disclose any conflicts of interest.
- For clinical studies submitted in a marketing application, including a supplement or amendment to an original application, that the applicant or Food and Drug Administration (FDA) relies on to establish that the product is effective, and any study in which a single investigator makes a significant contribution to the demonstration of safety, investigators must submit a financial disclosure to the FDA. For multi-site studies, the financial disclosure is typically submitted to the study sponsor, who submits forms for all site investigators to the FDA.
Templates/forms
- Submit a Conflict of Interest Disclosure - Application
Training
- Education on conflicts of interest is completed upon hire and annually during UMMC compliance training.
- Review the training in HealthStream by logging into the UMMC Intranet.