Protocol non-compliance (2)

How to self-report non-compliance?

You should notify the ethics committee about the details and reasons of a deviation at the soonest opportunity. You should also describe any remedial actions that you have taken. You may attach any relevant documents to provide clarification.

If you would like to make further improvement to the way you conduct your study, you should also submit a ‘protocol amendment’ application with the non-compliance report.

If the incident has caused actual harm to subjects, then an ‘adverse event’ report should be submitted too. 

What will the ethics committee do with the report?

Your report will be subjected to either an expedited (delegated) review or a full board review.

Minor or administrative deviations that do not affect the scientific soundness of a study nor compromise the rights, safety or welfare of subjects will usually undergo expedited review. A full board review is conducted for major protocol deviations or violations that could critically affect subjects’ safety or data integrity.

What are the possible outcomes?

The committee may:

• require no further action,
• recommend corrective and preventive actions,
• suspend ethics approval until all issues are addressed, or
• withdraw approval in cases of fraud or unresolved serious safety issues.

Where clarification is needed, you may be asked to submit further documents or asked to attend a meeting.

What should you do after making the report?

At all times, you should keep subjects who have been affected by the incident well-informed, and take their concerns seriously.

You and your research team should reflect on why a non-compliance incident has occurred. You should implement any necessary actions to resolve any harm that has been done and prevent it from happening again.

It is also important to ensure that everyone in the research team is well-supported to perform their tasks properly. Besides conducting proper training, regular team meetings will help to identify and resolve any difficulties that team members could be facing in their roles.

Who else do you need to report to?

You should promptly inform all your subjects if significant changes have to be made to your study, or if the study has to be suspended or terminated.  

Where applicable, you may also need to inform your sponsor, the NPRA (for drug trials) and/or the MDA (for medical device research) about any incidents of non-compliance. ^(11,13)

Regulatory or disciplinary actions to researchers are not common, but could happen when persistent or multiple serious non-compliance issues were identified. You should not deliberately conceal any incidences of non-compliance.