There are no ethical concerns. All patients will receive routine standard of care according to the hospital. There is no research related intervention. Institutional approval will be required by each participating centre in order to get permission for collecting observational clinical information. This approval must be obtained before the start of inclusion.
Each centre must report to the ESA their local approval process and send the following two things:
- POPULAR Approval Documentation Coversheet
- A letter of approval / notification receipt from their ethics / local authority (letter can be in local language)
We are happy to inform you that the POPULAR study protocol has recently been approved by the Ethical Committee in Munchen, Germany with waiver of consent process. Read the approval official document and its translation: POPULAR Munchen Ethics Committee Approval
Here is a template of Accompanying letter for your submission to Ethics Committee : POPULAR Ethics Committee Submission Accompanying letter