title: [Institutional review board of the French college of obstetricians and gynecologists (CEROG).].
abstract: 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.
authors.affiliation: Collège national des gynécologues et obstétriciens français, 184, rue du Faubourg-Saint-Antoine, 75012 Paris, France. xavier.deffieux@abc.ap-hop-paris.fr
authors.forename: X
authors.initials: X
authors.lastname: Deffieux
authors.forename: C
authors.initials: C
authors.lastname: Vayssiere
authors.forename: E
authors.initials: E
authors.lastname: Azria
authors.forename: R
authors.initials: R
authors.lastname: Porcher
authors.forename: O
authors.initials: O
authors.lastname: Parant
authors.forename: J
authors.initials: J
authors.lastname: Clavier
authors.forename: J
authors.initials: J
authors.lastname: Guibert
authors.forename: A
authors.initials: A
authors.lastname: Benachi
authors.forename: V
authors.initials: V
authors.lastname: Houfflin-Debarge
authors.forename: J-M
authors.initials: JM
authors.lastname: Jouannic
authors.forename: P
authors.initials: P
authors.lastname: Rozenberg
authors.forename: G
authors.initials: G
authors.lastname: Andre
authors.forename: Y
authors.initials: Y
authors.lastname: Ansquer
authors.forename: R
authors.initials: R
authors.lastname: Rouzier
authors.forename: A
authors.initials: A
authors.lastname: Benbassa
authors.forename: P
authors.initials: P
authors.lastname: Collinet
authors.forename: J-P
authors.initials: JP
authors.lastname: Ayel
authors.forename: B
authors.initials: B
authors.lastname: Jacquetin
authors.forename: P
authors.initials: P
authors.lastname: Morice
authors.forename: L
authors.initials: L
authors.lastname: Boubli
authors.forename: M-V
authors.initials: MV
authors.lastname: Senat
authors.forename: L
authors.initials: L
authors.lastname: Brunet
authors.forename: G
authors.initials: G
authors.lastname: Levy
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000458:organization & administration; D005602:France; D006176:Gynecology; D009774:Obstetrics