Protocol amendment (2)

How to apply for a protocol amendment?

You should submit the amended protocol, document or study material to the ethics committee, together with anything else that is affected by the amendment.

All amended sections should be clearly indicated. All revised documents should have updated version numbers and dates.

What will the ethics committee do with the application?

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

Minor changes (such as adding a new telephone number or correcting grammatical and spelling errors) will usually be approved via expedited review. A full board review may be indicated if the proposed amendment heightens the risks to subjects, affects the scientific merit of the study or involves substantial changes to the management of the study.

What are the possible outcomes?

The ethics committee may approve, reject, suggest modifications or recommend further actions to your proposed changes. Where clarification is needed, you may be asked to submit further documents or invited to attend a meeting. 

What should you do after making the application?

Amendments should not take effect before ethics approval is granted, unless urgent changes are needed to protect research subjects from harm, or you are only making minor administrative changes.

Once approval has been granted, you should inform your team members about any changes to the way the study will be conducted. All older versions of the protocol or protocol-related documents should be kept for future reference purposes. 

Who else do you need to report to?

You should inform all subjects about any significant changes to the conduct of your study and obtain their consent again.   

Where applicable, you should also inform your sponsor, the NPRA (for drug trials) and/or the MDA (for medical device research) about proposed changes to the protocol. ^(11,13)