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 | ||