–
Concept:
Under FDA rules (21 CFR Part 54), investigators in FDA-regulated studies must disclose any significant financial interests related to the research to the sponsor and to the FDA.
The sponsor/institution must then implement a management plan to mitigate conflicts of interest (and report disclosures to the FDA as required).
–
Example:
A principal investigator owns stock in the sponsor company.
The PI discloses this to the sponsor and the FDA; the sponsor implements a COI management plan (e.g., independent data monitoring, PI excluded from data analysis, and disclosure of the conflict in the consent form).