Which entity is responsible for reporting the investigator's financial interests to the FDA?

The sponsor is responsible for reporting the investigator's financial interests to the FDA. This is an important aspect of regulatory compliance and the ethical conduct of clinical trials. The sponsor, which can be a pharmaceutical company or an organization funding the research, is tasked with ensuring that any potential conflicts of interest related to financial interests are disclosed to maintain the integrity of the study and protect participant safety.

In clinical research, transparency regarding financial interests is crucial, as it helps to identify and mitigate any potential biases that might arise from investigators having financial ties to the study's outcomes. By reporting these interests, the sponsor demonstrates their commitment to ethical practices and adherence to regulatory requirements established by the FDA.

The investigator themselves typically has the responsibility to disclose their financial interests to their institution, and the institution may then relay this information to the sponsor. However, the onus of formally reporting this information to the FDA lies with the sponsor. This system helps ensure that all potential conflicts are managed appropriately throughout the study process, safeguarding the integrity of the research and the welfare of participants.