A propos du comité guinéen d’éthique pour la recherche en santé

L’esprit fondateur de l’éthique de la recherche dans le monde contemporain souligne la dimension morale inhérente à tout acte de recherche au service de l’humanité. En Guinée, l’essor du concept est associé à la normalisation du cadre de recherche en santé et au développement des interventions de santé publique dans le pays. C’est au cours de l’élaboration de la Stratégie de la Recherche Nationale Essentielle en Santé (RNES) que le code d’éthique y afférent a été formulé. Il a été intégré un peu plus tard au code de santé publique ayant fait l’objet de la loi n°021/AN/97 du 19 juin 1997.

Le Comité National d’Ethique pour la Recherche en Santé (CNERS) a été créé l’année  suivante par le Décret N° D/218/PRG/SGG du 29 octobre 1998. Il a été placé sous la tutelle du Ministère de la Santé Publique qui doit lui fournir les moyens de son fonctionnement. Son siège est établi à Conakry, dans l’enceinte de la Blue zone de Dixinn.

La première équipe du CNERS a été mise en place par le Décret N°D/99/078/PRG/SGG du 02 août 1999 pour une durée de trois (03) ans renouvelables. Lors de sa première session, en Octobre 1999, le CNERS a élu un bureau de quatre (04) membres, et a choisi une femme pour la présidence.

Mission / Attributions

Le Comité National d’Ethique pour la Recherche en Santé (CNERS) a pour mission de protéger les personnes participant à une recherche. A ce propos, elle veille sur la qualité scientifique et éthique de la recherche conduite en République de Guinée dans le domaine de la santé, biomédical et environnemental. A ce titre, le CNERS a pour principales attributions de :  

 

  • Examiner les protocoles de recherche en santé qui lui sont soumis, et donner un avis sur leur acceptabilité du double point de vue scientifique et éthique ;
  • Veiller à ce que les recherches se déroulent en conformité avec les dispositions du Code d’Ethique pour la Recherche en Santé ;  
  • Proposer, s’il y a lieu, des modifications du Code d’Ethique 
  • Examiner les problèmes d’ordre éthique relatifs à la recherche en santé qui lui sont soumis par des institutions ou des individus.

Composition

Le CNERS est composé de dix-sept (17) membres, choisis en raison de leur intérêt pour les problèmes d’éthique de la recherche, de leur compétence, de leur expérience et de leur représentativité. Il regroupe des professionnels de santé, ainsi que des non spécialistes pour représenter les couches sociales les plus larges et les valeurs morales les plus profondes de la communauté nationale : médecins, épidémiologistes, pharmaciens, statisticiens, spécialistes de santé publique, représentants des ministères de la santé et de la justice, des institutions de formation et de recherche, des confessions religieuses et des ONG, des associations de malades.

Les membres du comité ne sont jamais remplacés au même moment. Il existe un régime de renouvellement de l’expertise qui suggère le changement d’un tiers des membres à la fois. Cette approche répond au souci de formation des nouveaux adhérents, et de facto le maintien de la tradition développée et entretenu au sein du comité. L’équipe peut, par ce fait, demeurer efficace tout en changeant de membres.

Organisation et fonctionnement

Pour son fonctionnement, le CNERS dispose d’un bureau exécutif chargé d’impulser et de coordonner les activités du comité et de veiller à son bon fonctionnement ainsi qu’à la tenue régulière de ses réunions. Il est composé de cinq membres élus au sein du CNERS : un(e) président(e), un(e) vice-président(e), un secrétaire général, un secrétaire chargé du suivi de la mise en œuvre des protocoles et un trésorier. Le poste de secrétaire général est tenu par le chef de section en charge de la Recherche au Ministère de la Santé.

Depuis sa création, le CNERS dispose d’un siège dans l’enceinte de l’hôpital national Ignace Deen. En 2018, il a bénéficié d’un nouveau local à travers le projet AFREENET, dans l’enceinte de la BlueZone de Dixinn. L’ancien bureau, devenu reclus au fond de l’hôpital Ignace Deen, sert désormais de bloc des archives pour entreposer l’ensemble des documents administratifs et des protocoles reçus par le CNERS. Le siège administratif du comité est géré par une assistante administrative. Sous la direction de la Présidente et du Secrétaire général, elle est chargée d’appuyer le comité dans son fonctionnement courant : 

 

  • Recevoir les protocoles de recherche et tout courrier soumis à l’examen du Comité ;   
  • Gérer la documentation et les archives du CNERS ; 
  • Préparer les sessions du Comité ;   
  • Rédiger les comptes rendus et procès-verbaux des rencontres du Comité ;   
  • Diffuser les recommandations et les décisions du CNERS.

Les membres du comité sont organisés autour de trois (03) commissions techniques de travail. La première s’occupe des actions de plaidoyer, communication et sensibilisation. La seconde est responsable des activités de formation. Et la troisième conduit les opérations de suivi-évaluation des réalisations du comité.

Réalisations et partenariat

A partir de 2012, le CNERS a été redynamisé grâce au projet de renforcement de ses capacités « Support project for the strengthening of Guinean National Ethics Committe » financé par l’EDCTP (le partenariat Union Européenne & Pays en Développement pour les Essais cliniques). A travers cette assistance, il a pu rénover et équiper son siège à Ignace Deen, élaborer ses documents techniques de travail (manuel des procédures, dépliant), son plan stratégique pour les cinq (05) prochaines années, ses plans de communication et de suivi-évaluation, réaliser la formation de ses membres et de certains chercheurs, effectuer des voyages d’études auprès des comités homologues des pays voisins ainsi que des visites de sites de recherche locaux, organiser une
enquête CAP auprès des chercheurs, mettre en place son site WEB, etc.

Depuis sa mise en place, le Comité a examiné plus de 300 protocoles portant sur des projets de recherches soumis par des institutions scientifiques nationales seules ou en partenariat avec des institutions et chercheurs internationaux. Plusieurs de ces projets sont multicentriques et regroupent des chercheurs des pays développés et des pays en développement. Ces projets constituent une source importante de renforcement des capacités des équipes de recherche des  pays du Sud.

Parmi ces institutions de recherche et universités du Nord qui sont des collaborateurs dans les projets de recherche menés en Guinée et dont les protocoles de recherche ont été examinés par le CNERS, on peut citer : les CDC/Atlanta, le MRC/Angleterre, l’IMT/Hambourg, l’IMT/Anvers, la London School of Hygiene ant Tropical Medicine, l’Université Mc Gill de Montréal, le NIH américain, l’IRD/France, l’institut Pasteur de Paris, l’Université Paris VI, les Universités de Florence, de Tours, de CapeTown, le MRC d’Afrique du Sud et de Gambie, etc.

Il existe également un partenariat fécond entre les chercheurs et institutions scientifiques guinéens en matière de recherche en santé, avec leurs homologues de la sous-région et du reste de l’Afrique comme : le Mali, le Sénégal, le Bénin, le Burkina Faso, le Ghana, la Gambie, la Sierra-Léone, l’Afrique du Sud, l’Algérie, le Kenya, le Mozambique, la Tanzanie…

Le CNERS a récemment noué un partenariat avec ses homologues de certains pays comme la Côte d’Ivoire, le Sénégal, le Togo, le Mali. Le partenariat local est en cours de renforcement. Des partenaires comme l’OMS, SOLTHIS ont commencé à apporter leur appui pour le renforcement du CNERS.

Perspectives

Le CNERS est en train de mettre en place les bases nécessaires à l’affirmation de sa personnalité aux différents niveaux du système national de recherche en santé, afin de conférer aux activités de recherche fiabilité et crédibilité. Pour y parvenir, il s’applique à :

 

  • Faire connaitre le CNERS, en ce
    qui concerne ses attributions et son organisation auprès des autorités, des
    chercheurs en santé, des organismes de coopération, des partenaires au
    développement et de la communauté en général ;
  • Créer les conditions propres à
    assurer au CNERS le meilleur fonctionnement possible ;
  • Former les cadres et chercheurs en
    santé, aux principes de l’éthique en matière de recherche en santé ;
  • Décentraliser le CNERS au niveau régional et préfectoral, et appuyer la création des comités institutionnels

Pour obtenir ces résultats dans l’esprit de son plan stratégique, le CNERS élabore un plan d’actions annuel dont l’exécution est minutieusement suivie.

 

Télécharger le décret de création du CNERS ici

Télécharger le code éthique ici

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