Federal regulations (HHS and FDA) require that institutions have written procedures to ensure that the following determinations are promptly reported:

• Any unanticipated problems involving risks to subjects or others;
• Any serious or continuing noncompliance with FDA or HHS regulations or the requirements or determinations of the IRB; and
• Any suspension or termination of IRB approval.

You will be notified of these determinations in writing. In addition, the following officials and entities may be notified: funding agency, Department Head, Dean, Institutional Officials, and others. When reporting to regulatory entities (e.g., FDA and/or OHRP) is required, the IRB will make every effort to notify the study team in writing, by phone, or in person prior to forwarding the report to the regulatory entity.

See HRP 052-SOP-Post Review for more information regarding the IRB’s obligations to report this information to regulatory and university officials and department leadership.