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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 ensure records documenting compliance and 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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