19. Reporting

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.

(DoD Instruction, 4.b.(4). Research Involving Human Subjects Conducted by a Non-DoD Institution, Non-DoD Institutional Responsibilities)