Table 2.

Characteristics of the application process for Ethical approval across the various European countries involved in GenOSept

Country	National coordinator	No of ICUs	Is the ethics approval process centralized or local?		In what form is the ethics application made?		Which of the following are usual members of the ethics committees?			Outcome of GenOSept application process: range of centres approved			Month/Year ethics application submitted & decision received			Additional info / modification	National guidelines for Research in ICU pts
			National or Regional EC	Local EC	Paper application	Web-based Application	Lay	Medical	Legal	All units	Some units	Approval refused	Submitted	Approved or rejected	Interval (months)
Austria	Novak	1	√	–	√	–	√	√	√	√	–	–	02/07	09/07	7	√	√a
Belgium	Damas	7	√	–	√	–	√	√	√	√	–	–	02/06	05/06	3	√	–
Czech Re	Sramek	8	√	√	√	–	√	√	√	√	–	–	07/05	07/05	< 1	√	–
Croatia	Gasparovic	2	–	√	√	–	–	√	–	√	–	–	11/07	3/08	4	–	–
Estonia	Sarapu	2	√	–	√	–	√	√	√	√	–	–	06/05	06/05	< 1	–	–
France	Chiche	8	√	–	√	–	√	√	–	√	–	–	10/05	10/06	12	√	√
Germany	Bloos	12	–	√	√	–	√	√	√	–	√	–	07/05	08/05	1	–	–
Greece	Armanagidis	2	–	√	√	–	–	√	–	√	–	–	04/06	04/06	< 1	–	–
Hungary	Bobek	10	√	–	√	–	–	√	–	√	–	–	10/05	09/07	24	√	–
Ireland	Ryan	7	–	√	√	–	√	√	√	√	–	–	03/06	10/06	7	–	–
Israel	Weiss	5	√	–	√	–	√	√	√	–	√	–	08/05	02/06	6	√	√
Italy	Cotogni	24	–	√	√	–	√	√	√	–	√	–	01/06	03/06	2	√	√
NL	Hazelzet	1	–	√	√	–	√	√	√	√	–	–	01/07	11/07	9	–	√
Poland	Mikstacki/Tamowicz	22	√	–	√	–	–	√	–	√	–	–	05/05	06/05	1	–	√
Portugal	Carneiro	0	√	√	√	–	√	√	√	–	–	√	08/05	08/06	< 1	–	–
Serbia	Surbatovic	2	–	√	√	–	√	√	√	√	–	–	07/06	07/06	< 1	–	√
Spain	Sirgo/Rello	19	√	√	√	–	√	√	√	√	–	–	07/05	08/05	1	–	√
UK	Hinds	28	√	–	–	√	√	√	√	√	–	–	03/06	04/06	1	–	√
Totals	18 countries	160	11	10	17	1	14	18	13	14	3	1	Median interval = 1.5 months			7	9

^aAustria: the REC which received the application recommended inclusion only of those critically ill patients who had capacity to give consent