The study is preliminarily planned to start on 1 January 2016 after receiving permission from the Ethics Committee in all countries.
The proposed study is an observational study with no interference with the patient’s routine care, which is in accordance to the good clinical practice and no research-related interventions, will be introduced. Therefore, no ethical concerns are expected and ethical approval may not be required in some centres. However, where ethical approval is required, this approval must be obtained before the start of inclusion.
Patient consent is normally required unless there is a specific and explicit exemption by the relevant Ethical Committee.
A template that can be used for your application to Ethics Committee:
Each participating centre must report to ESA all the steps of Ethical submission and approval or notification, using the Approval Documentation Coversheet, to be signed sent to ESA with a proof of approval/notification (local language is OK), by scan to firstname.lastname@example.org.
Ethical approval and coversheets:
– Aretaieio Hospital, Medical School, University of Athens: E_030-001_EC approval and coversheet
– Karolinska University Hospital, Sweden: E046-001 EpiMAP Chief Investigator EC approval and coversheet