The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster trial conducted (...) in a low-resource setting with the Ottawa Statement; to identify ethical issues in the design or conduct of the trial not captured adequately and to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; the classification of lay health workers who deliver study interventions as health providers or research participants; the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; the timing of gatekeeper engagement, particularly when researchers face funding constraints; providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and defining vulnerable participants needing protection in low-resource settings. (shrink)

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share (...) their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. (shrink)

The Science Granting Councils Initiative (SGCI) in Africa aims to strengthen the capacities of selected science granting councils (SGCs) in sub-Saharan Africa in order to support research and evidence-based policies that will contribute to Africa’s economic and social development. As part of SGCI, a study was conducted in 2021 to investigate strategies that have been adopted by fifteen SGCs participating in SGCI in promoting ethical practice in research and innovation. Data collection for the study was mainly based on a data (...) abstraction form that was completed for each country by an assigned focal person with a background in research ethics. The focal persons relied on various methods including document and website review and interviews with senior officers at the SGCs. The study specifically sought to describe the strategies and activities being implemented by the 15 SGCs in promoting ethics and integrity in research and innovation. The study revealed various strategies that were being implemented by the 15 SGCs aimed at promoting ethics in research and innovation including requiring proof of research ethics committee approval before releasing research funds and the inclusion of ethics questions in the application form for funding. It was observed that some activities and strategies were generic to most SGCs for example the development of general/standard guidelines for the conduct of research in each respective country. Overall, the different SGCs were involved in a broad spectrum of activities aimed at promoting research ethics and this paper presents an opportunity for cross fertilization of ideas. By providing a summary of the various strategies that SGCs are using in promoting ethical conduct of research, it is hoped that this paper will lead to improvements in the ways SGCs provide support and oversight over the research that they fund. (shrink)

Background Caring is a core function of nurses and it confers upon them ethical obligations as ethical agents. Failure to carry out such ethical obligations raises ethical concerns. This study was not intended to explore ethical concerns, but the reported findings reveal problems which have ethical implications. This paper aims to elucidate the ethical issues inherent in the findings and propose strategies to mitigate them. Research design and methods An exploratory-descriptive qualitative design was used within a larger Action Research Study. (...) Data were collected through focus group discussions with nurse/midwives, and through exit interviews which were conducted with the women who participated in the study on their day of discharge. Six focus group discussions and thirty exit interviews were conducted, and data were analysed through thematic analysis. Participants and research context The study took place at selected maternal and child healthcare settings in Lilongwe, Malawi. The participants were nurse/midwives and women who were admitted in maternal and child healthcare settings and were purposively sampled. Ethical considerations Ethical approval was obtained from the relevant ethics committee and all ethical guidelines were followed in the conduct of the study. Findings The findings are presented under three themes which emerged from the data. The findings reveal effects of staff shortages on patient outcomes, problems experienced in low resource clinical settings and disrespectful nurse/patient communication. Conclusion The findings reveal that institutional factors constrain moral agency and patient safety is severely compromised in some of the clinical settings in Malawi which raises serious ethical concerns. (shrink)