Non-Compliance

Non–compliance is failure to follow DoD, DoN, and NPS regulation and policy governing human subject research. Allegations of non-compliance are investigated by the IRB and results reported to the Department Chair, NPS President, Department of the Navy, and research sponsor. Possible corrective actions may include:

• Suspension or termination of research.
• Destruction and loss of use of all human subject data collected.
• Completion of additional ethics training.
• Notifying subjects of the non-compliance.
• Loss of privilege to conduct human subject research.

Examples of Non-Compliance

This can include, but is not limited to:

• Failure to obtain IRB approval prior to conducting research.
• Failure to follow the approved the protocol.
  • Modifying consent forms, survey questions, interview questions, etc.
  • Increasing the number of subjects.
  • Destroying consent forms or research records.
  • Piloting the research without IRB approval.
  • Failure to store and safeguard data according to the protocol.
• Failure to obtain informed consent from subjects.
• Implementing changes to the research without IRB approval.
• Continuing human subject research after approval expired.