What is an amendment?
Amendments are alterations to the procedures or documentation involved in undertaking a study that do not significantly change the study objectives, alter the physical or mental integrity of the participants, introduce new research questions or cleave research questions from the original study, alter the scientific value of the study, change the conduct or management of the study or the quality or safety of any medicinal product. Valid amendments can be approved by Chairman’s action. All other changes require a new application.
Examples of valid amendments are:
- Minor changes to Participant Information Sheets explaining procedures
- Minor changes to assessments (for example, minor wording changes or changes to layout)
- Changes to the size of the sample
- Recruitment of participants with new procedures
- Changes to personnel (other than the Principal Applicant)
- Changes to the arrangements for storing or transporting samples
- Inclusion of new sites and investigators
- Extension of the study beyond the period specified in the application form
Examples where new applications are needed are:
- Changes to the design or methodology
- Changes to background information affecting the scientific value of the study
- Changes to procedures undertaken by participants (including significant increases in duration).
- Replacing the intervention under investigation
- Changing the study population (for example, from adults to children)
- Cleaving a subset of the assessments to answer an unrelated research question
- Changes to the Principal Applicant
- Extensions to the study requested after the current end date
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. It would be helpful if documents were given version numbers that incremented with the amendment.
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.