Obtaining assent for research involving children in Malaysia: a position statement from the Academy of Medicine of Malaysia College of Paediatrics

Obtaining assent for research involving children in Malaysia: a position statement from the Academy of Medicine of Malaysia College of Paediatrics
E J Khoo, B A Zilfalil, M K Thong, S C Yong, S C Chee, J K Lee, S H Teh, F Taib, F C Cheah
Medical Journal of Malaysia, July 2024; 79(4) pp 494-497
Abstract
The Academy of Medicine of Malaysia College of Paediatrics acknowledges the role of children in research and this position statement explores the ethical considerations in obtaining assent from minors in the Malaysian context. It highlights the importance in respecting children’s agency and navigating cultural complexities. The College proposes flexibility in the minimum age for assent of at least nine years old, while emphasising the need for a tailored assent procedure. Addressing language and cultural diversities and expanding local empirical research on a formal assent process are some building blocks in developing a standardised nationwide process in obtaining assent from children.

Recommendations
Considering the challenges associated with obtaining ethical and effective assent for research involving children in Malaysia, the College proposes several recommendations to address these issues towards best practice.

1. Recognising the importance of respecting children as individuals with their own rights, the College suggests a flexible approach to the minimum age for assent. Specifically, the College recommends raising the minimum age to at least nine years old, guided by current available evidence. Additionally, this flexibility should be applied with consideration for the complexity of the research, ensuring that the assent process is age appropriate. Such an approach not only acknowledges the child’s agency but also aids in the development of decision-making skills crucial for adulthood, contributing to the cultivation of trust in an era of evolving healthcare systems.
2. The College emphasises the need for tailored assent procedures that account for varying educational levels among children. To enhance comprehension, the College suggests customising assent procedures by integrating visual aids, multimedia resources, verbal explanations and open question sessions. Innovative methods, such as combining images with text or utilising multimedia, can further ensure the development of its best practice.
3. The College calls attention to the dynamic nature of the assent process, emphasising that obtaining assent is a dialogue. While the College advocate for researchers documenting a child’s assent for accountability, the process is not a one-time signature on a form, that could all the more so place a burden on the child to engage in a significant act they might not fully comprehend. Recognising assent as an ongoing and dynamic process, continuous evaluation is desirable.
4. The College addresses the diverse linguistic landscape of Malaysia by recommending proactive language accessibility. This includes addressing translation needs to ensure inclusivity. Furthermore, the College advises granting sufficient time and privacy for consultations with parents, guardians and children. Additionally, extending this process to include discussions with extended family members or community members, as applicable, is deemed crucial. Cultural nuances that may influence the assent process should be acknowledged and navigated accordingly.
5. Given the absence of data on the appropriate age for obtaining assent in Malaysia, the College recommends and supports the conduct of local empirical research in this area. This research aims to better understand the cultural contexts within Malaysia and subsequently formulates the basis for developing assent practices nationwide. Such an approach stresses the importance of tailoring assent procedures to the unique cultural diversity present in Malaysia.

Conclusion
Addressing the challenges of obtaining assent from minors in Malaysia requires a multifaceted approach. This position statement by the College not only delineates its challenges but also outlines a path forward, emphasising the importance of respecting children’s developing capacity and ensuring effective communication, while navigating Malaysia’s socio-cultural landscape. Establishing local policies and guidelines must be dynamic and responsive to evolving research and societal norms. Advocating for best practices at a local level will deepen understanding and inform the formulation of standardised nationwide assent practices.