Notification of Study Amendments
Following approval of a research project by LJMU research ethics committee (REC) it is the responsibility of the principal investigator to inform the REC of any major changes made to the project (amendments) following approval. There are 2 types of possible amendments:
1. Major Amendments – any changes which affect the safety or physical or mental integrity of the participants for the conduct or management of the study.
Examples of major amendments are:
- Substantive change in procedures used
- Changes to the study population (i.e. numbers, age range, inclusion/exclusion criteria)
- Change in the principal investigator
- Changes to study documentation such as participant information sheet or consent form
Where a major amendment to a study is to be introduced this must be approved by LJMU REC prior to implementation. The principal investigator should submit an Amendment Notification form to the ethics committee secretary with any associated documentation eg amended participant information sheet, consent form.
Where amended documents are submitted any changes should be highlighted.
2. Minor Amendments – any changes which have no significant implications for participants or the conduct of the study.
Examples of minor amendments are:
- Correcting typographical errors
- Minor clarifications of the protocol
Where a minor amendment is to be introduced there is no requirement for notification prior to implementation although a record of any changes should be kept by the principal investigator.
If you have any doubts over whether or not a proposed change is a major or a minor amendment please contact Sue Spiers on firstname.lastname@example.org or 904 6476.
Amendments to NRES approved studies