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

The responsibility for reporting the investigator's financial interests to the FDA primarily falls on the sponsor. According to federal regulations, particularly those governing clinical trials, sponsors are required to disclose certain financial interests of investigators, including any significant financial interests that could affect the integrity of the research study. This requirement ensures transparency and helps to mitigate potential conflicts of interest that may arise during the conduct of clinical trials.

While other entities like the IRB and the investigator's institution may also deal with financial disclosures, their roles are more about oversight and ensuring compliance with ethical standards rather than direct reporting to the FDA. The investigator also has a responsibility to disclose their financial interests to their institution and the sponsor, but it is ultimately the sponsor that submits this information to the FDA as part of their obligations. This chain of reporting helps maintain the integrity and credibility of the research findings.