BackgroundOn site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.MethodsThis was a retrospective review of research site monitoring reports covering a period of four years.ResultsThe monitoring was conducted by the Uganda National Council for Science and Technology, the National Drug Authority and the National HIV/AIDS Research and Ethics Committee over the period 2007 to 2010.The monitoring team was usually three members comprising of two experts in research ethics and an assistant. A total of 28 site monitoring visits covering 40 research projects were reviewed. 25% of the site monitoring reports revealed violation of the regulatory requirement for valid ethical approval. 36% of the site reports showed some instances of informed consent violation, 28% showed violation of the rights and welfare of research participants, 38% revealed that sites did not report SAEs to regulatory authorities and many sites lacked adequate GCP and GCLP. However, most of the sites monitored had adequate facilities to conduct the respective studies and good working practices.ConclusionThis model employed by the monitoring teams to evaluate research compliance is effective in auditing ethical practice. Compliance monitoring is feasible and affordable in a resource limited setting. Research protocol non compliance is still a major problem in Uganda, and there is need for a pro-active approach to this vice by all stake holders if ethical conduct of research is to be achieved.
ABSTRACT:The study was undertaken to examine water quality in the distribution network of Kampala City by assessing five storage reservoirs and four consumer taps. The aim was to evaluate residual chlorine decay and relate it to the risk of recontamination. Physicochemical quality of water in the distribution network was temperature 25.6(24.23-28.66) pH 6.6 (6.5-7.1); turbidity 1.9 (0.5-4.5) NTU; colour 17.2 (2.0-54) PtCo, ammonia 0.02 (0.0-0.05) mgl -1 , and Fe2 + 0.005 (0-0.0.08) mgl -1 . Residual chlorine decay was significant between the Water Treatment Plant (WTP) and the storage tanks (Total Chlorine, F=35.67, P< 0.05; Free Chlorine, F=37.97, P<0.05) and consumer taps (P<0.05) and chlorine concentrations were lower that the WHO (2008) recommended levels in two reservoirs and most of the community standpipe taps. The findings in this study provide a typical scenario of water distribution network in African urban areas and the conditions that increase the risk of recontamination. The information generated is important to the scientific community for designing further research to ensure consumer safety. The Water Board can use the generated information and recommendations in this study for better planning and management of the water distribution network. @JASEM
Commentators have argued that when research conducted in a developing country shows an intervention to be effective, the intervention must be made “reasonably available” to the host population after the trial. But this standard is sometimes too stringent, and sometimes too lenient. It offers a benefit, but not necessarily a fair benefit.
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