What if I want to make changes/amendments to the protocol?

Approval is limited strictly to the protocol as submitted in your application. If there is any variation or modification which would alter the standing of the protocol, the investigator must notify the Committee for further consideration and approval. (Go to Forms and Guides to download the Modification Form) The investigator must also notify any unforeseen events that might affect continued ethical acceptability of the project. Variations include such things as the addition of researchers to the study, changes to recruitment methods, sites, methodology.