An Institutional Review Board (IRB), also known as an Ethics Committee (EC), is a committee formally designated to review, approve, and monitor biomedical and behavioral research involving human subjects. Its primary purpose is to safeguard the rights, safety, and well-being of all participants in a Clinical Trial before the study begins and throughout its duration. The IRB is composed of scientists, non-scientists, and community members to ensure a comprehensive and objective review.
Before any clinical research can commence, the IRB must review all aspects of the study protocol, including the scientific merit, the risk-benefit analysis, and the process used to obtain informed consent. The IRB’s approval is a mandatory prerequisite for adherence to Good Clinical Practice (GCP) and regulatory requirements globally. They possess the authority to approve, require modifications in (to secure approval), or disapprove any research. The continuous oversight provided by the IRB ensures that the ethical standards and regulatory compliance are maintained, protecting vulnerable populations and upholding the integrity of the research.
