Submitting Changes to a Study
Per MCW IRB SOP: Modifications to an Approved Protocol; Investigators who wish to change or modify an ongoing IRB-approved research study, must submit an amendment to the IRB and receive IRB approval before implementing any modification.
When an Investigator receives an amendment or a request for change to the approved project, they must submit the amendment promptly to secure final IRB approval within 90 days from notification of the change. In addition, Investigators and study teams should work to respond quickly to any requested modifications to meet this expectation. This timeframe ensures the changes can be implemented in a timely process to protect the rights, safety and welfare of their subjects and the continued conduct of the project in accordance with the protocol.
Examples of changes that need review by the IRB include but are not limited to:
• Change in PI
• Changes in key personnel
• Increase or decrease of enrollment numbers
• Change in recruitment methods
• Changes in the consent form
• Changes in an Investigator Brochure or device information
• Change in procedures or randomization
• Adding or dropping an arm of the project
• Changes in questionnaires, surveys, interview scripts, advertising
• Changes in funding
• Changes in the title of the project
• Addition of new study sites or locations which will be under the direction of the MCW/FH Principal Investigator
Investigators must include the IRB approval documents from the outside institution or contact the HRPP office to discuss the option of coordinated reviews.