AUDIT OF PROTOCOL SUBMISSIONS TO THE UNIVERSITY OF IBADAN/UNIVERSITY COLLEGE HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE (2002-2007)

Abstract

The University of lbadan/University College Hospital Health Research Ethics Committee (UI/UCH HREC) was established in 2002 to review and approve all research proposals submitted by staff and students of the two institutions. Research proposals submitted are reviewed according to international guidelines and the Nigerian National Health Research Ethics Code (NHREC). Since inception, there had been one audit of protocols submitted to the committee. The objectives of the current review are to determine the types of protocols submitted, the duration for review and reasons for revision and amendment. This retrospective review of all proposals submitted to the UI/UCH HREC during a 6-year period (2002 -2007) was performed using a 25 item questionnaire. The questionnaire contained information on month and year of submission, status of principal investigator, type of funding, scope, location and nature of research. Other questions include the study design, sample size, study participants, the number of revision required before approval, reasons for revision and the time interval between submission and approval. Categorical data were presented as proportions and using frequency distribution. Student t-test was used to compare the mean time from submission of protocols to approval for protocol granted exempt approval and protocol requiring review. The results showed that the committee received a total of 752 protocols between 2002 and 2007, out of which 728 (97%) could be retrieved for this audit. Of the 728 protocols audited, 56 (0.08%) were still under consideration while decision has been reached on 656 (90%) protocols. Six hundred and eighteen protocols were while 38 protocols were not approved. Clinical researches on hospital patient based in single tertiary health institution constituted the bulk of the protocol received accounting for 44.9% of the entire protocols. The principal investigators were mainly postgraduate students (67.1%) while academic staff constituted 21.3%. Thirty-three (5.3%) of the protocols were gained

exempt approval, 464 (75.1%) required only minor modifications after first review. 118 (19.1%) protocols required a second review while 3 (0.5%) required a third review. Of the 566 protocols requiring review, the main reasons for revision in 50% (283/566) was inadequate information on the informed consent form. Other reasons for revision include, use of inappropriate methodology and statistics, scientific justification, simple size calculation, inclusion criteria, inadequate information on treatment of patient. The average time from submission to approval is approximately 21 weeks (95% CI: 20 - 23 weeks); it took a shorter time for protocols granted exempt approval (6 weeks. 95%CI: 4 - 8 weeks) and internationally sponsored protocols (n = 64, mean: 16weeks. 95%Cl: 12 - 20 weeks). The period of time between submission of research proposal and approval is significantly affected by the need for review, number of revision and sponsoring agent (p<0.05). In conclusion, majority of the proposals reviewed by the UI/UCH HREC were submitted by postgraduate and undergraduate students (78.7%.). Providing a worksheet for reviewer to hasten the process of review and increasing the number of trained reviewers and expertise available for consultation are recommended to improve the review process.