IRB-Non-Compliance-Title

Non-Compliance

IRB-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.