Any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.  Amendment requests are reviewed at the same level the initial study was approved under. If the amendment changes the risk profile to participants or procedures that require additional levels of review, then a new review level will be implemented for the protocol.