Background: Paediatric oral health research in Malaysia is governed by international ethical frameworks and national regulatory requirements. While reporting of ethics approval and parental consent is well established, the documentation of child assent remains inconsistent. The frequent classification of dental studies as minimal risk may permit expedited review pathways or consent waivers, raising concerns about transparency. This scoping review aimed to map the reporting of ethics approval, parental consent and child assent in Malaysian paediatric oral health research published between 2001 and 2025, with particular focus on describing current practices and documenting how assent procedures are reported in the absence of mandated requirements.
Methods: The review followed the PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline. An electronic search of five databases: PubMed, Web of Science (WOS), Scopus, MyJurnal and the National Medical Research Registry (NMRR) was conducted. Eligible studies comprised empirical research involving children aged 0-17 years in Malaysia. Data extraction focused on ethics approval, parental consent, and child assent. Transparency of assent reporting was assessed using a structured three-point framework informed by Malaysian Medical Research and Ethics Committee (MREC) guidelines for children aged 7-17 years.
Results: Seventy-one articles met the inclusion criteria. Of these, 88.7% (n = 63) reported ethics committee approval and 91.5% (n = 65) documented parental consent, whereas child assent appeared in only 6.9% (n = 5). Reporting of ethics committee approval and parental consent increased substantially, rising from below 50% in 2001-2005 to above 95% after 2015. Child assent was not reported until 2021-2025, appearing in 17.9% of studies during this period. Among the five studies reporting assent, three used written forms, two relied on implied assent, and only one provided a detailed procedure aligned with ethical standards.
Conclusions: Ethics approval and parental consent are now routinely reported in Malaysian paediatric oral health research. However, documentation of child assent remains limited and often lacks procedural detail. Strengthening ethical transparency will require standardised, age-appropriate assent procedures and clearer editorial expectations. Improving reporting practices will better support children's developing autonomy, reinforce responsible research conduct, and promote greater trust in paediatric oral health research.
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