title: An appraisal of the process of protocol review by an ethics review conmmittee in a tertiary institution in Ibadan.
abstract: 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.
authors.affiliation: Department of Anaesthesia, College of Medicine, University of Ibadan, Ibadan, Nigeria. dryinka@yahoo.com
authors.forename: O R
authors.initials: OR
authors.lastname: Eyelade
authors.forename: A J
authors.initials: AJ
authors.lastname: Ajuwon
authors.forename: C A
authors.initials: CA
authors.lastname: Adebamowo
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002985:Clinical Protocols / Q000592:standards*; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000458:organization & administration / Q000706:statistics & numerical data; D032984:Ethics, Research; D006784:Hospitals, Teaching; D006801:Humans; D008485:Medical Audit; D009549:Nigeria; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors