The investigator is responsible for ensuring that any changes in an approved protocol are submitted to the IRB for review before the changes are incorporated into the research.
The only exception to this rule is when a change in protocol is necessary to eliminate an apparent immediate hazard to a research participant or participants.
When a change in an approved protocol is initiated without prior IRB approval to eliminate an apparent immediate hazard to a participant, the investigator must report the change to the IRB within ten (10) days of implementation, at which time the IRB will determine whether the change was necessary to eliminate an apparent immediate hazard to a participant and will also review the change to determine whether it is consistent with ensuring research participants’ continued welfare. For more information, see guidance on Change of Protocol for Safety Reasons.
A change in protocol can be submitting to the IRB by using the appropriate change of protocol form. Those submitting to the Social & Behavioral Science IRB or the Education Research IRB must use the electronic protocol submission process in WebKit. The Health Sciences IRB and Minimal Risk IRB use paper forms only.
The form should be signed by the investigator, reference the protocol number and title, and describe the proposed changes. The proposed changes will be reviewed by IRB staff or by the full IRB at the next regularly scheduled IRB meeting. The investigator will be notified of the results of the review.