[Institutional review board of the French college of obstetricians and gynecologists (CEROG).].
OBJECTIVE
To report the rules and the activity of the institutional review board of the French college of obstetricians and gynecologists (Comité d'éthique de la recherche en obstétrique et gynécologie [CEROG]) created in 2008. The submission requirements are also described.


METHODS
Retrospective study.


RESULTS
The Ethical Review Committee [institutional review board of the French college of obstetricians and gynecologists (CNGOF)] CEROG have examined 65 project studies in 2008. The median number of submitted studies was 5.5 per month (IQR: 3.75-6.25). The origins of the submission were as follows: tertiary care university hospitals (n=63, 97 %), Inserm (n=1), INRA (n=1). Researches were found to be in conformity with the French laws and regulations, to conform to generally accepted scientific principles and medical research ethical standards in 44 cases (68 %). In 13 cases (20 %), the study has been forwarded to the Persons Protection Committee (PPC) since it concerned biomedical research or "usual care research" (soin courant). In six cases (9 %), the investigators have not responded to IRB suggestions. In two cases (3 %), the information form has been judged unsatisfactory.


CONCLUSIONS
The CEROG is the first national IRB in obstetrics and gynecology. This new committee clarifies IRB submission procedure in France concerning non-interventional studies in the field of obstetrics and gynecology.
Deffieux
X
X
Collège national des gynécologues et obstétriciens français, 184, rue du Faubourg-Saint-Antoine, 75012 Paris, France. xavier.deffieux@abc.ap-hop-paris.fr
Vayssiere
C
C
Azria
E
E
Porcher
R
R
Parant
O
O
Clavier
J
J
Guibert
J
J
Benachi
A
A
Houfflin-Debarge
V
V
Jouannic
J-M
JM
Rozenberg
P
P
Andre
G
G
Ansquer
Y
Y
Rouzier
R
R
Benbassa
A
A
Collinet
P
P
Ayel
J-P
JP
Jacquetin
B
B
Morice
P
P
Boubli
L
L
Senat
M-V
MV
Brunet
L
L
Levy
G
G
D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000458:organization & administration; D005602:France; D006176:Gynecology; D009774:Obstetrics