When must an investigator obtain IRB approval?

An investigator must obtain Institutional Review Board (IRB) approval before enrolling any patients in a clinical trial to ensure that the rights, welfare, and safety of the participants are protected. The IRB's primary responsibility is to review and oversee research studies involving human subjects, ensuring that the research complies with ethical standards and regulatory requirements.

Acquiring IRB approval prior to patient enrollment is crucial because it assesses the study's design, procedures, informed consent processes, and potential risks to ensure that they are acceptable. Enrolling patients without IRB approval would be unethical and could compromise participant safety, legal compliance, and the integrity of the study itself. This requirement emphasizes the importance of participant protection prior to any research activities.

Collecting data, drafting the protocol, or proceeding without prior approval presents significant ethical and regulatory issues, making the necessity of obtaining IRB approval beforehand clear.