Any proposed change to the IRB protocol or consent form(s), including a change in investigator(s) or key personnel, must be reviewed and approved by the IRB prior to implementation, except where an immediate change is necessary to eliminate hazard to the participant.
If the changes are significant, a completely revised protocol form may be requested, with proposed changes highlighted. Changes will be reviewed initially by the IRB Office, and the investigator will be notified whether the changes require review by the expedited method or by the convened board at the next scheduled meeting. Minor changes may be administratively approved by the Chair. Appropriate steps will be taken in the IRB Office to ensure a timely review and approval of the changes.
