Ethical Reporting of Consent and Assent in Paediatric Oral Health Research in Malaysia: A Scoping Review.

Background: Paediatric oral health research in Malaysia is governed by international framework alongside national requirements. Reporting of ethics approval and parental consent is well established, but child assent remains inconsistently documented. The frequent classification of dental studies as minimal risk may allow expedited review or consent waivers, raising concerns about transparency. This scoping review therefore aimed to map the reporting of ethics approval, parental consent and child assent in Malaysia paediatric oral health research published between 2001 and 2025, with a particular focus on describing current practices and documenting how assent procedures are reported in the absence of mandated requirements. Methods: This review was conducted and reported in accordance with 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 performed. Eligible studies included empirical research involving children aged 0-17 years in Malaysia. Data extraction focused on ethical approval, parental consent, and child assent. The transparency of assent reporting was assessed using a structured three-point framework informed by MREC guidelines for children aged 7-17 years. Results: A total of 72 articles met the inclusion criteria. Of these, 88.9% (n = 64) reported ethics committee approval and 93.1% (n = 67) documented parental consent, whereas child assent appeared in only 6.9% (n = 5). Reporting of ethics 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. Of 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: Ethical committee approval and parental consent are now routinely reported in Malaysian paediatric oral health research, demonstrating broad compliance with international and national frameworks. However, documentation of child assent remains limited and often lacks procedural detail. Strengthening ethical transparency requires standardised, age-appropriate assent procedures and consistent editorial requirements. Improving reporting practices will enhance the protection of children's developing autonomy, reinforce responsible conduct of research, and promote greater trust in paediatric oral health research.