Final answer:
An Institutional Review Board (IRB) is an independent group that ensures the protection of the rights, safety, and well-being of human subjects involved in research protocols involving humans. It must review and approve any changes to the study protocol, even in life-threatening situations.
Step-by-step explanation:
An Institutional Review Board (IRB) is an independent group that ensures the protection of the rights, safety, and well-being of human subjects involved in biomedical and behavioral research protocols involving humans.
Regarding your statement, 'Any change in the study protocol must have approval from IRB, except in life threatening situations,', it is not true of the IRB. The IRB must review and approve any changes to the study protocol, even in life-threatening situations. This is to ensure that the rights and well-being of the participants are protected at all times.
The IRB conducts risk-benefit analysis to determine whether clinical research should proceed, assures that trials comply with regulations, and is designated by the trial sponsor to approve, monitor, and review biomedical and behavioral research protocols involving humans.