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:

- Purpose or design of a study
- 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 s.spiers@ljmu.ac.uk or 904 6476.

Amendments to NRES approved studies

If your research has been approved by an NRES committee any amendments to your study must be approved by the REC from which approval was granted. For further information please visit http://www.nres.nhs.uk/applications/after-ethical-review/notification-of-amendments/

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



Page last modified by Guy Kilgallen on 21 January 2014.
 
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