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)

Introduction Globally, healthcare providers (HCPs), hospital administrators, patients and their caretakers are increasingly confronted with complex moral, social, cultural, ethical, and legal dilemmas during clinical care. In high-income countries (HICs), formal and informal clinical ethics support services (CESSs) have been used to resolve bioethical conflicts among HCPs, patients, and their families. There is limited evidence about mechanisms used to resolve these issues as well as experiences and perspectives of the stakeholders that utilize them in most African countries including Uganda. Methods (...) This phenomenological qualitative study utilized in-depth interviews (IDIs) and focus group discussions (FGDs) to collect data from Uganda Cancer Institute (UCI) staff, patients, and caretakers who were purposively selected. Data was analyzed deductively and inductively yielding themes and sub-themes that were used to develop a codebook. Results The study revealed there was no formal committee or mechanism dedicated to resolving ethical dilemmas at the UCI. Instead, ethical dilemmas were addressed in six forums: individual consultations, tumor board meetings, morbidity and mortality meetings (MMMs), core management meetings, rewards and sanctions committee meetings, and clinical departmental meetings. Participants expressed apprehension regarding the efficacy of these fora due to their non-ethics related agendas as well as members lacking training in medical ethics and the necessary experience to effectively resolve ethical dilemmas. Conclusion The fora employed at the UCI to address ethical dilemmas were implicit, involving decisions made through various structures without the guidance of personnel well-versed in medical or clinical ethics. There was a strong recommendation from participants to establish a multidisciplinary clinical ethics committee comprising members who are trained, skilled, and experienced in medical and clinical ethics. (shrink)

Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. (...) The data were analyzed thematically using NVivo version 12 software. Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists’ practices and attitudes toward informed consent. (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.