How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi

Abstract

Background Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Methods Qualitative research was conducted with children and parents in three settings in Southern Malawi (low- and high-income urban and rural), to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. Results We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Conclusions Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines.

Operationalization of assent for research participation in pre-adolescent children: a scoping review

“…In the 30 studies focusing on opinions and perceptions of assent, the main populations studied were children (60%), parents (23.3%) [ 23 , 26 – 31 ], researchers (23.3%) [ 15 , 17 , 29 , 30 , 32 – 34 ] and healthcare professionals (16.7%) [ 15 , 22 , 23 , 30 , 31 ]. The main themes identified in these studies were: children’s desire to be involved and their empowerment [ 24 – 26 , 32 , 35 – 39 ], need for cultural considerations [ 12 , 17 , 18 , 26 , 28 , 30 , 31 , 40 ], specific context considerations and opinion variation [ 21 – 23 , 29 , 33 , 34 , 41 ] as well as need for age and developmental considerations [ 13 , 27 , 42 – 45 ].…”

“…Fifteen studies focused on pediatric assent practicalities and identified complexity and variability of assent practices [ 23 , 46 ], variability of clinicians and researchers’ knowledge about assent [ 22 , 33 ] as well as cultural and context-specific assent considerations [ 17 , 18 , 29 , 30 , 34 , 47 ] as important themes.…”

“…Only 30.8% of these studies specified what information was provided to research participants. This information included, for example, common risks and benefits, potential serious side effects, description of research procedures and informing children that they can refuse to participate [ 12 , 29 ]. One study provided information by age category to ensure age and developmental appropriateness of the language used.…”

“…However, the reported minimal age required for obtaining pediatric assent varied considerably (between 5 and 13 years) even within North America. Furthermore, only 14% of studies specifying a minimal age actually provided a justification for their choice [ 16 , 29 , 41 , 42 ]. This variability is in keeping with the broader literature in which some authors propose a “school-age threshold”, suggesting “considerable capacities of 5–7 year-old children” [ 43 ] while others advocate that children less than 11 years of age have a limited understanding of research information [ 34 ].…”

A network of empirical ethics teams embedded in research programmes across multiple sites: opportunities and challenges in contributing to COVID-19 research and responses

“…A central component of much of the empirical ethics work across our institutions, which over time has been valuably supported, critically reviewed, and deepened through the GHBN, is engagement with community members and broader publics [25][26][27][28][29][30][31][32][33][34][35] . An immediate potential opportunity and need under COVID-19 was to work with established community engagement networks with whom we had long term relationships in order to: 1) learn about community members' and the broader publics' priorities and concerns in relation to the response, and to communicate these up through institutions and to local, national and global policy makers and influencers through our wider networks in order to inform locally tailored information giving and action; 2) seek community members' advice and inputs on how to manage closure or appropriate continuation of non-COVID-19 related studies; and 3) engage community members on prioritizing and planning COVID-19 studies.…”