Le Comité d'éthique de la recherche en obstétrique et gynécologie (CEROG)

X. Deffieux; C. Vayssiere; E. Azria; R. Porcher; O. Parant; J. Clavier; J. Guibert; A. Benachi; V. Houfflin-Debarge; J. M. Jouannic; P. Rozenberg; G. Andre; Y. Ansquer; R. Rouzier; A. Benbassa; P. Collinet; J. P. Ayel; B. Jacquetin; P. Morice; L. Boubli; M. V. Senat; L. Brunet; G. Levy

doi:10.1016/j.jgyn.2009.12.009

Le Comité d'éthique de la recherche en obstétrique et gynécologie (CEROG)

X. Deffieux, C. Vayssiere, E. Azria, R. Porcher, O. Parant, J. Clavier, J. Guibert, A. Benachi, V. Houfflin-Debarge, J. M. Jouannic, P. Rozenberg, G. Andre, Y. Ansquer, R. Rouzier, A. Benbassa, P. Collinet, J. P. Ayel, B. Jacquetin, P. Morice, L. BoubliM. V. Senat, L. Brunet, G. Levy

Résultats de recherche: Contribution à un journal › Article › Revue par des pairs

Résumé

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. Conclusion: 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.

Titre traduit de la contribution	Institutional review board of the French college of obstetricians and gynecologists (CEROG)
langue originale	Français
Pages (de - à)	401-408
Nombre de pages	8
journal	Journal de Gynecologie Obstetrique et Biologie de la Reproduction
Volume	39
Numéro de publication	5
Les DOIs	https://doi.org/10.1016/j.jgyn.2009.12.009
état	Publié - 1 janv. 2010

mots-clés

CEROG
CNGOF
Ethics
Ethics committee
IRB
Institutional review board

Accès au document

10.1016/j.jgyn.2009.12.009

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Contient cette citation

Deffieux, X., Vayssiere, C., Azria, E., Porcher, R., Parant, O., Clavier, J., Guibert, J., Benachi, A., Houfflin-Debarge, V., Jouannic, J. M., Rozenberg, P., Andre, G., Ansquer, Y., Rouzier, R., Benbassa, A., Collinet, P., Ayel, J. P., Jacquetin, B., Morice, P., ... Levy, G. (2010). Le Comité d'éthique de la recherche en obstétrique et gynécologie (CEROG). Journal de Gynecologie Obstetrique et Biologie de la Reproduction, 39(5), 401-408. https://doi.org/10.1016/j.jgyn.2009.12.009

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title = "Le Comit{\'e} d'{\'e}thique de la recherche en obst{\'e}trique et gyn{\'e}cologie (CEROG)",

abstract = "Objective: To report the rules and the activity of the institutional review board of the French college of obstetricians and gynecologists (Comit{\'e} d'{\'e}thique de la recherche en obst{\'e}trique et gyn{\'e}cologie [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. Conclusion: 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.",

keywords = "CEROG, CNGOF, Ethics, Ethics committee, IRB, Institutional review board",

author = "X. Deffieux and C. Vayssiere and E. Azria and R. Porcher and O. Parant and J. Clavier and J. Guibert and A. Benachi and V. Houfflin-Debarge and Jouannic, {J. M.} and P. Rozenberg and G. Andre and Y. Ansquer and R. Rouzier and A. Benbassa and P. Collinet and Ayel, {J. P.} and B. Jacquetin and P. Morice and L. Boubli and Senat, {M. V.} and L. Brunet and G. Levy",

year = "2010",

month = jan,

day = "1",

doi = "10.1016/j.jgyn.2009.12.009",

language = "Fran{\c c}ais",

volume = "39",

pages = "401--408",

journal = "Journal de Gynecologie Obstetrique et Biologie de la Reproduction",

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Deffieux, X, Vayssiere, C, Azria, E, Porcher, R, Parant, O, Clavier, J, Guibert, J, Benachi, A, Houfflin-Debarge, V, Jouannic, JM, Rozenberg, P, Andre, G, Ansquer, Y, Rouzier, R, Benbassa, A, Collinet, P, Ayel, JP, Jacquetin, B, Morice, P, Boubli, L, Senat, MV, Brunet, L & Levy, G 2010, 'Le Comité d'éthique de la recherche en obstétrique et gynécologie (CEROG)', Journal de Gynecologie Obstetrique et Biologie de la Reproduction, VOL. 39, Numéro 5, p. 401-408. https://doi.org/10.1016/j.jgyn.2009.12.009

TY - JOUR

T1 - Le Comité d'éthique de la recherche en obstétrique et gynécologie (CEROG)

AU - Deffieux, X.

AU - Vayssiere, C.

AU - Azria, E.

AU - Porcher, R.

AU - Parant, O.

AU - Clavier, J.

AU - Guibert, J.

AU - Benachi, A.

AU - Houfflin-Debarge, V.

AU - Jouannic, J. M.

AU - Rozenberg, P.

AU - Andre, G.

AU - Ansquer, Y.

AU - Rouzier, R.

AU - Benbassa, A.

AU - Collinet, P.

AU - Ayel, J. P.

AU - Jacquetin, B.

AU - Morice, P.

AU - Boubli, L.

AU - Senat, M. V.

AU - Brunet, L.

AU - Levy, G.

PY - 2010/1/1

Y1 - 2010/1/1

N2 - 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. Conclusion: 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.

AB - 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. Conclusion: 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.

KW - CEROG

KW - CNGOF

KW - Ethics

KW - Ethics committee

KW - IRB

KW - Institutional review board

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U2 - 10.1016/j.jgyn.2009.12.009

DO - 10.1016/j.jgyn.2009.12.009

M3 - Article

AN - SCOPUS:77955655329

SN - 0368-2315

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JO - Journal de Gynecologie Obstetrique et Biologie de la Reproduction

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