What approval must be sought for research involving human subjects in clinical trials?

The correct answer is the institutional review board (IRB). In the context of research involving human subjects, an IRB plays a crucial role in ensuring the protection of participants' rights and welfare. Before any clinical trial or research study can begin, the proposed research must be reviewed and approved by an IRB. This review process assesses the ethical considerations, risks, and benefits of the study, ensuring that participant safety is prioritized and that the research complies with legal and regulatory standards.

The IRB is responsible for evaluating factors such as informed consent procedures, potential risks to the participants, and the overall design of the study. By requiring IRB approval, researchers must demonstrate that they have taken necessary precautions to safeguard the well-being of participants while conducting their research.

Other options are less relevant in this specific context. While medical staff may provide input or endorsements, it is ultimately the IRB that holds the authority to approve research involving human subjects. The Office of National Coordinator (ONC) primarily focuses on health information technology, rather than overseeing clinical trials. A governing board may have general oversight of the institution but does not specifically address the ethical and regulatory considerations of human subject research.