Why is the IRB Important?
An IRB committee ensures that scientific research prioritizes protecting the rights and welfare of its subjects. In 1979 the Belmont Report laid out basic ethical principles needed to create federal regulations protecting human subjects in research. These principles are respect for persons, beneficence, and justice. As an independent body an IRB evaluates research proposals based on these ethical principles and 45 CFR 46, the federal regulation governing research involving human subjects. Other FDA regulations provide additional guidance specifically for clinical trials and the use of investigational drugs and medical devices.
IRBs ensure that the study design, methods, and procedures are ethical and that the risks to human subjects are reasonable when considering the potential benefits of the study. The IRB has the authority to approve, require modifications to, or disapprove research studies involving human subjects.