I. Reporting Non-Compliance

 

Research non-compliance can be reported by two parties:

• Principal Investigator (PI) and Other Research Personnel:

Research personnel must report any potential non-compliance in the research as soon as possible or within 5 business days from the discovery of the non-compliance incident.

• Others Outside of the Research Personnel:

Research subjects, witnesses, or the general public can report any actual or suspected non-compliance to the KEP. In such cases, the reporter may choose to remain anonymous. The recipient of an anonymous report must inform the reporter that the issue will be investigated as far as possible based on the information provided. The recipient may suggest that the reporter provide additional details later if new information becomes available.

Reporters can fill out the Non-Compliance Reporting Form and send it via email to kep@lpem-febui.org to submit the report. Reports can be submitted anytime, meaning, the report can be reviewed outside of KEP’s regular cycle.

Reporters need to submit the following document:

• Non-Compliance Report Form

The document should be sent to kep@lpem-febui.org with the subject: Non-Compliance Report – (research title).

 

At the end of the KEP’s review process of the report, the reviewer can make one of three possible decisions:

• Continued with Corrective Actions:

The research may continue by implementing some corrective actions.

• Suspended:

The research team must fulfill all corrective actions or additional requirements before resuming the research.

• Terminated:

The review team assesses that the research should be fully terminated due to major non-compliance that has caused an unanticipated emergency event.

 

II. Corrective Actions

KEP can recommend corrective actions such as, but not limited to:

Minor Non-Compliance:

• Changes to the research protocol or procedures;
• Changes to the consent process or form;
• Notification to subjects about the non-compliance information if it may affect their willingness to continue participating in the research;
• Re-consenting subjects to participate again;
• Providing additional relevant information to subjects before participation;
• Post-approval monitoring or other monitoring actions deemed appropriate by KEP.

 

Major Non-Compliance:

• Changes to the research protocol or procedures;
• Changes to the consent process or form;
• Notification to subjects about the non-compliance information if it may affect their willingness to continue participating in the research;
• Re-consenting subjects to participate again;
• Providing additional relevant information to subjects before participation;
• Scheduling periodic follow-up reviews;
• Requiring researchers to complete courses/training;
• Monitoring research procedures or PSP processes;
• Suspension or termination of the research;
• Seizure of data;
• Restriction on researchers intervening with subjects;
• Referral to other organizational entities (e.g., Dean, Department Head, etc.);
• Post-approval monitoring or other monitoring actions deemed appropriate by KEP.

 

III. General Information

1.1. Non-Compliance:

Non-compliance is the failure of the researcher to adhere to the KEP-approved research protocol, KEP requirements, determinations, and institutional policies related to human subject research, and government regulations. This applies to the Principal Investigator and all members of the research team.

Based on the level of risk, there are two types of non-compliance: minor non-compliance and major non-compliance.

 

1.2. Minor Non-Compliance:

Minor non-compliance does not increase risk and does not jeopardize the rights and welfare of research subjects. Additionally, this type of non-compliance does not affect the integrity of the research and efforts to protect human subjects.

Examples of Minor Non-Compliance:

• A signed and dated consent form is missing, but other documentation shows that the subject agreed to participate in the research.
• A page is missing from the approved PSP Form, but the subject was later re-consented with the complete PSP procedure.
• The number of subjects enrolled exceeds the number approved by KEP.
• Research procedures were not conducted according to the protocol, but there is no potential increase in risk to subjects or compromise to data integrity.
• Minor dosing errors (if the research involves drug interventions) with little or no increased risk.
• Incomplete PSP documentation, including:
  • Missing subject or parent/guardian signatures (in studies involving children). But other documentation indicates voluntary participation and understanding of risks.
  • Missing investigator’s signature.
  • Copies of the form were not provided to the person signing the form.
  • Someone other than the subject wrote the date on the consent form.
• Failure to follow approved study procedures without affecting subject safety or data integrity:
  • Study procedures were conducted out of order.
  • Study visits were conducted outside the specified timeline (due to a shift in the research timeline).

 

1.3. Major Non-Compliance:

Major non-compliance potentially increases risk, jeopardizes the rights and welfare of research subjects, affects research integrity, and efforts to protect human subjects. There are two forms of Major Non-Compliance: Serious Non-Compliance and Continuing Non-Compliance.

1.3.1. Serious Non-Compliance:

Serious non-compliance can endanger the rights, safety, and welfare of human subjects. KEP also considers willful or serious breaches of KEP requirements as Serious Non-Compliance.

Examples of Serious Non-Compliance:

• Research procedures were not conducted according to protocol with potential increased risk to subjects or compromise to data integrity.
• Failure to follow the research protocol. For instance, enrolling subjects who do not meet eligibility criteria, enrolling subjects without proper consent, not performing safety procedures or laboratory tests, and making substantive changes to the research without KEP approval.
• Conducting research without an IRB review. For example, KEP discovers a study involving secondary clinical patient data to conclude the efficacy of a genetic testing process. The study team had not obtained ethical approval before conducting the research. Such activities should undergo ethical review as they aim to draw generalizable conclusions and involve identifiable human subject data.
• Procedures were not halted when requested by participants.

1.3.2. Continuing Non-Compliance:

Continuing non-compliance refers to previously reported non-compliance or a pattern showing a lack of understanding of human subject protection. Several examples of Continuing Non-Compliance include, but are not limited to:

• Failure to implement corrective actions provided by KEP.
• Repeated minor non-compliance.
• For the Principal Investigator, a pattern of deviations may occur in the same or different protocols. The pattern of deviations may involve repeated violations of the same policy/procedure and regulations.