Which federal regulation section primarily deals with the financial interests of clinical investigators?

The section of the federal regulations that primarily addresses the financial interests of clinical investigators is indeed 21 CFR 54. This regulation specifically focuses on the disclosure of financial interests and arrangements between sponsors and clinical investigators involved in research. It aims to ensure that potential conflicts of interest are disclosed, thereby protecting the integrity of the clinical trial process and safeguarding the rights and well-being of trial subjects.

In the context of clinical trials, the regulation mandates that sponsors provide information regarding any financial relationships they have with investigators that could potentially influence the study results. By implementing these requirements, 21 CFR 54 seeks to maintain public trust in the ethical conduct of clinical research.

The other sections mentioned focus on different aspects: 21 CFR 56 governs Institutional Review Boards (IRBs) and their role in reviewing research proposals for ethical compliance, 21 CFR 50 deals with the protection of human subjects and the informed consent process, while 21 CFR 812 relates to the investigational device exemption process. Each of these regulations plays a vital role, but 21 CFR 54 specifically targets the financial interests and conflicts that may arise for clinical investigators.