No protocol may be initiated until the investigator receives a final approval letter. For protocols given a status of re-review, a letter and resubmission form is sent to the investigator detailing the committee's concerns about the protocol and consent form. The investigator has 60 days to reply. Once a response is received, the revised protocol will be distributed to a designated reviewer who sits on the committee that originally reviewed it. He or she will present the protocol at the convened meeting.
Substantive discussion follows, a motion is made and a vote taken.
If the HIC still does not approve the re-review, the investigator is advised in writing and may also be invited to appear at the next meeting. If the committee feels that all issues have been satisfactorily addressed, a final approval letter will be issued. If no reply is received within the 60 day time limit, the protocol is withdrawn from consideration. Approval is valid for no longer than a one year period. Some protocols may be considered High Risk and will need to be reviewed at more frequent intervals.