Ethical Frameworks for Paediatric Clinical Research in Resource-Constrained Nigerian Settings: A Grounded Theory Development of Contextualised Research Ethics Principles

International research ethics frameworks developed primarily in high-income country contexts are insufficiently attentive to the specific ethical challenges arising in paediatric research conducted in resource-constrained Nigerian settings. These challenges include the ethics of enrolling vulnerable populations during humanitarian emergencies, community consent practices, capacity to obtain informed parental consent, benefit-sharing obligations, and standards of care comparators. This study employs constructivist grounded theory to develop a contextualised ethical framework for paediatric clinical research in Nigeria. Theoretical sampling was conducted across three phases, encompassing 76 in-depth interviews with paediatric researchers, research ethics committee members, caregivers of research participants, community leaders, and regulatory officials drawn from institutions across all six geopolitical zones. Documentary analysis of 42 ethics committee review records supplemented interview data. Constant comparative analysis and memo-writing produced a substantive grounded theory conceptualised as Relational Stewardship, comprising four core categories: contextual risk calibration, negotiated community legitimacy, transparent benefit reciprocity, and adaptive consent processes. The theory challenges atomistic Western notions of individual autonomy in consent and proposes communal assent as a morally valid supplement to parental informed consent in specific contexts. Practical principles derived from the theory are operationalised into a Nigerian Paediatric Research Ethics Framework applicable to IRB review processes. This study represents the first grounded ethics theory developed from Nigerian paediatric research contexts and makes an original contribution to the global discourse on contextualised research ethics. Keywords: research ethics, paediatric research, grounded theory, Nigeria, informed consent.