Background: Research involving children presents unique ethical challenges, requiring a delicate balance between parental authority and respect for the evolving autonomy of the child. This study aims to explore the perspectives of Malaysian children and their parents regarding decision-making for children’s participation in research.
Methods: Children under 18 years and their parents visiting outpatient clinics (as patients or visitors) at two tertiary hospitals in the Klang Valley, Kuala Lumpur, were recruited between April and May 2021. A qualitative study was conducted using semi-structured, in-depth interviews focusing on four domains: (I) children’s involvement in decision-making; (II) commonly requested information; (III) appropriate minimum age for assent; and (IV) preferred sequence of approach during recruitment. Interviews were audio-recorded, transcribed verbatim, and analyzed manually using both deductive and inductive thematic approaches.
Results: Ten children and eight parents participated. Four key themes emerged: (I) decision-maker; (II) consent and assent processes; (III) decision age; and (IV) person-approach sequence. While parental consent was considered necessary, most participants supported a shared decision-making model that incorporates the child’s voice. Participants suggested 17–24 years as the appropriate age for independent consent. Notably, both groups preferred researchers to first seek the child’s assent before approaching parents. Influencing factors included the research topic, perceived risks and benefits, prior findings, child interest, time commitment, cost, and data confidentiality.
Conclusions: Although parents play a pivotal role in decision-making, children wish to be actively involved in decisions regarding their research participation. These findings underscore the need to review and strengthen current research ethics guidelines, particularly by formalizing the assent process and encouraging shared decision-making.
