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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.

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