Amendment (of a study in progress)
If it emerges that a previously approved study requires adjustments which would have led to a different specification in the original EtCL application, you should inform the EtCL immediately. You can submit an amendment in the portal.
You are required to submit an amendment in the following cases:
- different participant groups;
- a different intervention;
- more or fewer tasks;
- a different estimation of the burden or risk to the participants.
The EtCL will of course do its best to provide a prompt reassessment, but if the study is much more ethically complicated due to the change, then the decision can only take place at the following EtCL meeting. For questions as to the necessity of an amendment, applicants can contact the EtCL secretary.