Amending a Protocol All amendments or revisions, major and minor, must be submitted to the IRB for approval. The determination as to whether an amendment is major or minor is made by the IRB Chair, and is determined by the degree of risk involved in the change. The request for approval of an amendment must be made in a letter signed by the Principal Investigator, describing the changes and indicating the reason for the change, the investigator's opinion as to what the impact of the change will be on the study and on the subjects in the study and whether or not changes are needed to the consent form.
Major amendments require the same type of review as new protocols.
The Primary Review Committee and the Full Board review major amendments, and written IRB approval before they may be implemented. A minor amendment would involve only logistical or administrative changes. These amendments can be granted expedited review, but they also require written IRB approval before they may be implemented. The only type of amendment that does not require written IRB approval before it may be implemented is a change that is necessary for the safety of a subject. In this event, the protocol change may be implemented immediately, and the IRB notified after the fact.