Who is informed when the Reviewing IRB makes a determination of serious and/or continuing noncompliance or suspends or terminates a study?

Under the SMART IRB Agreement, the Reviewing IRB is required to promptly notify the Overall PI, Site Investigators, and Relying Institutions of any finding of serious and or/continuing noncompliance or of apparent serious and/or continuing noncompliance with applicable human subjects protection regulations or with the requirements or determinations of the Reviewing IRB pertaining to the Relying Institution or its Research Personnel or pertaining to another institution if such finding relates to or may affect the conduct of the research study or the rights or welfare of human subjects participating in the study at the Relying Institution. In addition, the Reviewing IRB will communicate the steps it deems necessary for remediation of the noncompliance. The Reviewing IRB also will determine whether any federal agencies must be notified, such as the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), based on study funding, status of the Federalwide Assurances for the Relying Institution(s) involved (e.g., whether institutions have “unchecked the box”), and whether the study falls under FDA purview. A federal Reviewing IRB should inform applicable Relying Institutions if it will not inform the study sponsor of these determinations.