What is an amendment?
Amendments are changes to the procedures involved in undertaking a study. An amendment does not change the study objective or the introduction of new research questions. Furthermore, the integrity of the study should be preserved; that is, sub-studies cannot be cleaved from the original study. Any such change requires a new application.
Examples of valid amendments are:
- Changes to Participant Information Sheets explaining procedures
- Changes to the size of the sample
- Recruitment of participants with new procedures
- Additions or replacements of assessments that better address the study objectives
- Changes to personnel (other than the Principal Applicant)
Examples where new applications are needed are:
- Replacing the intervention under investigation
- Changing the study population (for example, from adults to children)
- Undertaking a subset of the assessments to answer a separate research question
- Introducing an assessment that opens a new research question
- Changes to the Principal Applicant
How do I apply for an amendment?
Write (email is acceptable) to the Committee explaining what the amendment entails and why it is needed. Include new versions of any documentation that has been changed. If the amendment alters any of the study procedures, update the original application form making clear (using highlighting, for example) what the changes are and include with your letter.
If you have any uncertainty about whether changes to your study are an amendment or require a new application, you can write to the Committee for advice in advance. In any correspondence with the Committee, please include the title and REC reference number.