OC 8378 REQUIREMENTS FOR THE ETHICAL CONDUCT OF CLINICAL RESEARCH IN CAMEROON, SUB-SAHARAN AFRICA: THE IMPORTANCE OF ACTIVE MONITORING

Abstract

BackgroundPrevious evaluation of the state of ethics regulation in Cameroon revealed: law regulating clinical research is lacking; existing committees lack infrastructure and financial support to sustainably review and effectively monitor approved protocols. The present Cameroon National Ethics Committee (CNEC)-EDCTP project aimed at implementing and evaluating active monitoring of clinical research in Cameroon.MethodsBetween 2011–2013, approved clinical trials and protocols involving transfer of biological materials abroad were consecutively monitored. The monitoring tool, a questionnaire on the conformity of key documents e.g. research protocols, ethical clearance, informed consent documents, investigator’s brochure, with a focus on GCP standards was sent to promoters/investigators ten days prior to the field visit. Teams of two-three monitors, made up of CNEC members and independent consultants, were mobilised per site (hospital/research institute/NGO). Reports with key recommendations were submitted to CNEC for review and approval, to different promoters/investigators, and the Regulatory Authority for action; the monitoring summary was submitted to EDCTP.ResultsUp to 22 site visits were done throughout the country, monitoring about 30 protocols within 11 hospitals, 9 research institutes, a National Programme and a non-governmental organisation. All sites had ethical clearance and administrative authorisation for research. From the registered number of research participants, less than half of the signed consent forms were available. Other issues were the lack of full involvement of local investigators, inexistence of material transfer and data sharing agreements with collaborative studies, non-implication of study communities/participants. As educators-consultants, monitors formulated recommendations to investigators, ethics committees and regulatory authority, insisting on the implication of local PI/collaborators with defined percentages of time to be devoted for research and good participatory practice among research communities/participants.ConclusionActive monitoring shows some formality in the application of ethical/administrative clearance in Cameroon. However, complex issues raised confirm the necessity of continuous monitoring to meet the high standards for clinical research ethics in Cameroon.