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.