BACKGROUND: Orphans and vulnerable children (OVCs) represent a significant population worldwide, enduring poor health and living conditions. Evidence-based interventions are needed. However, without parents, ethical concerns about including OVCs in research persist. The aim of our study was to better understand the ethical challenges facing researchers who work with OVCs. METHODS: We conducted semi-structured interviews with 12 international pediatric researchers working with OVCs in seven countries. We used descriptive content analysis to characterize the ethical rationale for inclusion and associated challenges. RESULTS: Researchers believed research was justified as a necessary means for informing evidence-based interventions to benefit OVCs directly or as a population. Ethical challenges included difficulty identifying OVCs given variation among children living without parents; difficulty identifying guardians among a range of caregivers; concerns about meaningfulness of guardian consent; difficulty assessing risk; and responding to children's many needs. CONCLUSIONS: A range of caregivers bear responsibility to protect OVC's interests in place of parents in research but are often not prepared to do so. This places greater burden on researchers to assess risks and respond to children's needs. Findings suggest that we should improve support and rethink the roles of guardians, researchers and older children in research participation and protection.
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Assent, Consent, International research ethics, Orphans, Vulnerable children, Vulnerable populations, Adolescent, Child, Child, Orphaned, Child, Preschool, Ethics, Research, Humans, Infant, Qualitative Research, Research Personnel, Vulnerable Populations