Suchergebnisse

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

BACKGROUND: Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. METHODS: Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out. TRIAL REGISTRATION: http://www.clinicaltrials.gov (identifier NCT00623337).