The IRB and the PI are required to report certain events to the HRPO. The following occurrences involving a DoD-supported research protocol must be reported to the DoD within 30 days of the event:
- Determinations of serious or continuing noncompliance
- Unanticipated problems involving risks to subjects or others
- Study suspensions or terminations
- Audits, inspections or investigations
- Results of the IRB Continuing Review
- Changes to the reviewing IRB
- Substantive amendments to the protocol that are approved by the IRB. Amendments must be reviewed and approved by the HRPO prior to implementing the change to the study.