Parental decision-making through psychological standpoint : Children's participation in clinical trial

Conducting clinical trials is essential for improving children's healthcare. However, parental involvement as a surrogate decision-maker remains a complex process influenced by cultural, social, and psychological factors. Furthermore, little is known about how parents navigate these challenges, particularly in regions of Malaysia, where the culture and religious beliefs strongly shape the health-related choices. Hence, this study aimed to explore in depth the processes, factors, and experiences that influence the parental decision-making on children’s participation in clinical trials. Accordingly, a qualitative design was employed, involving semi-structured interviews with 14 parents whose children participated in the clinical trials at two government hospitals located in Northern Malaysia. In particular, thematic analyses were employed to analyse the data. The findings revealed that the parents underwent a process that began with the referral stage, followed by initial engagement, information sharing, weighing risks and benefits, and finally achieving the decision-making process. Three major themes shaped this process: trust, culture and religion, and socioeconomic considerations. Specifically, trust in the clinical trial teams was central, and the clear and empathetic communication reinforced parental confidence. Meanwhile, cultural and religious beliefs, including Tawakkul, Redha, and Halal consideration, have provided moral guidance and psychological assurance. Moreover, socioeconomic factors involving financial benefits and access to beyond routine medical healthcare have motivated participation. At the same time, parental experiences reflected a mixture of hope, reassurance, and gratitude. Parents valued opportunities for better healthcare and close monitoring. Notably, parents perceived themselves as surrogate decision-makers, supporters, and collaborators in the clinical trial process. In conclusion, while the benefits of participation may facilitate enrolment, parents' experiences highlight the crucial role of trust, cultural sensitivity, and supportive relationships in ensuring informed and ethical consent. Overall, this study revealed a new insight into parents’ perspectives in Malaysia, suggesting that policymakers design culturally sensitive and parental-centred recruitment strategies to enhance future participation