Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB for any modifications of the previously approved research before implementing the proposed modification unless the change is made to eliminate an immediate risk to the participants.
If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB.
Changes to a previously approved protocol may include adding or removing research personnel, changing the study population, requesting a greater number of participants, changes in compensation, changes in recruitment materials, or changes in study procedures or instruments. These and other changes to approved protocols should be submitted to the IRB for review on the amendment application form:
Please attach copies of any study materials which have been revised to the amendment application before forwarding it to the Office of Research Compliance.
If you are unsure whether your changes can be handled as an amendment to your existing study, or would require a new application, please contact the Office of Research Compliance (815-751-8588, firstname.lastname@example.org) for guidance.