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Do I need to report changes to my protocol to the IRB?

Yes, amendments that require approval include (but are not limited to) changes in Principal Investigator (PI), inclusion/exclusion criteria for participants, research sites, recruitment strategies, informed consent process or documentation, assessment tools, testing procedures, confidentiality measures, and/or privacy safeguards for participants. Conducting a study with unapproved changes is a violation of policy and could result in a finding of noncompliance.