ECSubmissionFee object
Depends on request
Yes
Research ECs charge fees for trials with a commercial sponsor as fixed by the Royal Decree of 15 July 2004, but they are subject to an indexation each year (e.g. in 2015: fixed fees given as follows + 25 % approximately):
1. Interventional studies:
• Initial evaluation: single opinion committee: €1000.-; other committees: €300.- (local advice only).
• Amendments: €250.- to the EC that gave the single advice.
2. Non-interventional studies:
• Initial evaluation: single opinion committee. €400; other committees: €100 (local advice only).
• Amendments: €100 to the EC that gave the single advice.
No fees for non-commercial, academic trials are charged.
Moreover, the committees receive each year a certain amount of money from the CA : 75 % of the fees paid by commercial sponsors to the CA should be redistributed to the EC. This redistribution is done on the basis of the number of trial protocols evaluated by each committee- further details on the particular procedure is provided in the latest circular “Pending payments for ethics committees”, available on the FAMHP website in section Ethics committee.
