How does an investigator work with an IRB?
An investigator assures that an IRB is responsible for the initial and continuing review and approval of the proposed clinical study. The investigator also assures that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to participants or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to participants.