An appraisal of the process of protocol review by an ethics review committee in a tertiary institution in Ibadan
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Resumo
It is a well established norm that biomedical research involving human participants must conform to acceptable scientific principles and international codes of research ethics. The University of Ibadan/University College Hospital Health Research Ethics Committee (UI/UCH HREC) is the body that plays an oversight role and performs the function of a third party independent review of research protocols submitted by staff and students of the two institutions. A 6-year (2002- 2007) retrospective audit of the protocols submitted to the HREC was performed to determine the profile of the lead investigator, sources of funding for the research and the duration for review using a 25 item questionnaire. A total of 752 protocols were submitted, 618 protocols (82%) were approved while 38 protocols were not approved. The principal investigators were mainly postgraduate students (67.1%) while academic staff constituted 21.3%. The average time from submission to approval was approximately 21 weeks (95% CI: 20 - 23 weeks). The period from submission to approval is significantly affected by the number of revision required and the funding agent (p < 0.05); it took a shorter time to review internationally funded research.
Keywords: Research ethics committee, research protocol, an appraisal, review process
Résumé
C’est une norme bien établie que la recherche biomédicale utilisant les sujets humains doit se conformer aux codes éthiques internationaux et aux principes scientifiques acceptable. L’université d’Ibadan et le Comité Ethique du Centre Universitaire Hospitalier (UI/UCH HREC) est un corps qui joue un rôle de superviseur et performe ses fonctions de tierce partie indépendante sur les protocoles des projets de recherche soumis par les chercheurs et les étudiants de ces deux institutions. Pendant 6 ans (2002- 2007), un audit rétrospectif sur les protocoles soumis au HREC était faite pour déterminer le profile des investigateurs, les sources de financements des projets de recherches et la durée de l’étude des dossiers utilisant un questionnaire de 25 questions. Sept cent cinquante deux (752) protocoles étaient soumis, 618 protocoles (82%) ont été approuvés tan disque 38 protocoles étaient rejetés. Les investigateurs principaux étaient principalement les étudiants pré et postdoctorales (67.1%) lorsque les enseignants constituaient 21.3%. Le temps moyen mis de la soumission et l’approbation était de 21 semaines (95% CI: 20 - 23 semaines). Cette période était significativement affectée par le nombre de révision nécessaire et l’agence de financement (p < 0.05); Ceci prenait un temps plus court pour revoir les projets financés par les organismes ou institutions internationales.
Correspondence: Dr. Olayinka R. Eyelade, Department of Anaesthesia, College of Medicine, University of Ibadan, Nigeria. E-mail: dryinka@yahoo.com, oeyelade@comui.edu.ng
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