69. Additional DoD Reporting Requirements
University and affiliate principal investigators are responsible for informing the DOD-component human research protection officer within 30 days of any of the following:
- significant changes to the research protocol that are approved by a University IRB (including amendments approved by expedited procedures);
- results of IRB continuing review (including continuing review by expedited procedures);
- change of reviewing IRB;
- unanticipated problems involving risks to subjects or others, or serious or continuing noncompliance;
- suspension or termination DoD research; and
- notification that any part of the University HRPP is under for-cause investigation by any Federal department, agency or national organization for a DoD research protocol.
University IRBs will insure records documenting noncompliance with DoD regulations are accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the relevant DoD component.