Changes in approved research initiated without prior IRB review and approval are allowed under both the Common Rule and FDA regulations ONLY to eliminate apparent immediate hazards to subjects. These changes are expected to be rare. Any such changes made must be reported to the IRB within fourteen (14) business days of implementation as both an unanticipated problem and a change of protocol.

• In the unanticipated problem report, the investigator must give an overview of the situation including what changes were implemented prior to IRB approval and why these changes needed implementation prior to IRB approval to prevent immediate hazard to study subjects.
• In the change of protocol, the investigator needs to specifically explain any changes to the protocol and study documents (e.g., informed consent documents) that are required.

If a change of protocol is implemented prior to IRB approval and the IRB determines that the change was not necessary to eliminate apparent immediate hazards to a subject, the investigator’s action may be considered to represent noncompliance with the regulations governing human subjects research and result in additional action by the IRB.