If it emerges that a previously approved study requires adjustments which would have led to a different specification in the original FEtC-H application, you should inform the FEtC-H 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 FEtC-H 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 FEtC-H meeting. For questions as to the necessity of an amendment, applicants can contact the FEtC-H secretary.