2. Protocol amendments

You should make an application for ‘protocol amendment’ if you need to make changes to your research plans or revise any protocol-related documents after receiving initial ethics approval.

This is so that the ethics committee can assess the appropriateness of these proposed changes before they take effect.

It is common for researchers to make changes to their original research plans as they progress. In fact, hardly any studies will carry on without ever needing to change something. Examples of protocol amendments include: ^(14,15)

Changing the target sample size Changing the design of the advertisement used to recruit subjects Changing the frequency or amount of tissue sampling Adding new safety information to the Investigator’s Brochure of a study drug Adding a new research team member or collaborator Declaring a new conflict of interest