Under HHS and FDA regulations, what is the IRB responsible for?

The Institutional Review Board (IRB) plays a crucial role in ensuring the protection of human subjects involved in research. Its primary responsibility is to evaluate research proposals to ensure that the rights, welfare, and well-being of participants are safeguarded. This includes assessing the ethical implications of the research, ensuring informed consent is obtained, and monitoring the research to ensure compliance with ethical standards throughout the study's duration.

In contrast, overseeing all laboratory experiments is a broader scope that may involve various compliance bodies beyond the IRB. Managing data confidentiality agreements focuses more on data management and privacy, which falls outside the primary ethical review responsibilities of the IRB. Lastly, while funding approvals can be a part of the research process, the IRB does not have the authority to approve funding; its focus is strictly on the ethical considerations of research involving human subjects. This distinction highlights the IRB's fundamental role as a guardian of ethical standards in research rather than a financial or operational oversight body.