Before conducting a clinical trial, it is necessary to obtain approval from an Institutional Review Board (IRB). The IRB is responsible for ensuring that the study is conducted in an ethical and safe manner, and that the rights and welfare of the study participants are protected. The IRB will review the study protocol and informed consent form to ensure that they meet ethical and regulatory standards. It is important to note that IRB approval is required before any study activities can begin, including recruitment of participants and data collection.