The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was “Evolution of Research Ethics in Uganda and the Region: Past, Present and Future”. We were asked to address the topic: “The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research”. The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose strategies for (...) effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub‐Saharan Africa. Inferring from the ‘evolutionary’, ‘flexible’, and ‘general’ nature of the CIOMS guidelines, we proposed a six‐point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence‐based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a ‘bioethics culture’ among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines. (shrink)

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

On 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.