Revision to an Approved Study
Revision to an Approved Study form is used to request ethics review of a modification proposed to a study approved for conduct at the MUHC. If the proposed revision is an amendment to modify a procedure, method or condition described in the research protocol, or the REB approved informed consent or assent document, or would modify a clause in the study agreement, review by REB is required.
The form is also used to submit for “information purposes” a revision intended to advise the REB of an editorial or administrative correction. A formal response from the REB is not required when the submission is an editorial or administrative revision.
Revision to an Approved Study [doc] Revision to an Approved Study [pdf]
Annex A - Change of Investigator Study
Annex A is used to notify the REB of a change to the study team involving an Investigator, a Study Coordinator or another team member to whom the Principal Investigator allocates specific research authority. The corresponding change must be made to the “Study Delegation Log” in the research records.
Since changing the Principal Investigator is an amendment to the study, REB review and approval is required before making the change. Annex A is used to submit the information and must be accompanied by the sponsor's correspondence approving the change of Principal Investigator.
