According to FDA regulations, who is responsible for disclosing individual conflicts of interest in clinical studies?

In the context of clinical studies, the responsibility for disclosing individual conflicts of interest primarily lies with the researcher. Researchers have the ethical and regulatory obligation to disclose any financial or personal interests that could influence their research, as this is crucial for maintaining transparency, integrity, and public trust in the research process.

This requirement is part of the broader emphasis on protecting participants and ensuring ethical conduct in research. Researchers must declare potential conflicts to the organization conducting the study, the Institutional Review Board (IRB), and typically the study sponsor as well. By doing so, they help ensure that appropriate measures can be taken to manage any potential biases that may affect the findings or the treatment of study participants.

The study sponsor, the organization conducting the study, and the IRB all play important roles in monitoring and managing conflicts of interest, but the initial responsibility to disclose these conflicts rests with the individual researcher. This helps to ensure that the research is conducted with a commitment to ethical standards and transparency.