Assent forms are often densely packed with detailed information about the study’s purpose, procedures, risks, and benefits, along with legal disclaimers. This can overwhelm children, leading to confusion or disengagement. In international trials, this challenge is compounded by cultural differences in communication styles. In some cultures, the presentation of extensive written information may seem unnecessary or even something not to be trusted, as oral communication is traditionally more valued.

Challenges Across Cultures and Languages

Any patient-facing document needs to be sensitive to the cultural dimension of how information is expected to be received. High-context cultures rely on implicit communication and shared understanding, whereas low-context cultures prefer explicit, detailed information. Many assent forms are designed in low-context cultures (e.g. USA, UK) where the quantity of information may feel overwhelming or redundant in high-context cultures. Consider that some assent forms can run into fifteen pages.

Also, cognitive processing and learning styles vary across cultures. Some cultures prefer narrative storytelling, while others favour more structured formats.

Misunderstanding Risks and Benefits Across Cultures

Assent forms must communicate potential risks and benefits clearly and appropriately. However, children across diverse cultures may have varying perceptions of risk and probability. For instance, the concept of “1 in 1,000 chance” may be abstract and confusing, particularly in cultures with different numerical literacy practices.

This can result in unrealistic expectations or fear-driven decisions. In some cultures, risks may be interpreted more emotionally, while others may perceive medical risks as fate or destiny, influenced by religious or cultural beliefs.

Risk perception is understood differently from culture to culture. There are differences in numerical literacy and probability. So, in cultures with oral or non-numerical traditions, statistical explanations may be meaningless or confusing.

Cultural beliefs about risk in relation to health also differ. For example, beliefs about what causes illness (spiritual? Biomedical?) can influence how risks are perceived and understood.

Regarding ethical practices, there could be conflicting norms. In some collectivist cultures, the focus on community well-being may overshadow individual risk assessment. This can affect the decision-making process.

Perceived Obligation

Children are particularly vulnerable to influence from authority figures, including parents, doctors, and researchers. This challenge is magnified in hierarchical cultures where respect for authority and consensus decisions from the community override individual choice. In such contexts, children may be influenced by social desirability bias, feeling pressured to agree, especially if they perceive that it will please their parents or community leaders.

Perceived obligation undermines the voluntary nature of assent, leading to participation driven by duty rather than informed choice. This raises ethical concerns about autonomy and the validity of assent.

What are the Solutions?

To enhance comprehension and cultural relevance in assent forms, it is crucial to localise content using culturally relevant terms, idioms, and communication styles. Using culturally resonant visual aids, such as cartoons, diagrams, videos, and interactive digital tools, makes complex concepts more relatable. Pilot testing with children from target cultural and linguistic groups ensures effective communication, as already practiced in Clinical Outcome Assessment validation. A layered information approach - presenting essential details upfront with expandable sections or supplementary oral discussions - caters to different cultural communication preferences. Digital tools, including multimedia presentations and animated stories, can engage children in narrative-focused cultures. Using culturally relevant examples and infographics to explain risks and benefits enhances understanding. Involving community leaders or cultural mediators ensures accurate interpretation, while community consent models in collectivist cultures respect group decision-making and individual autonomy.

Conclusion

The challenges surrounding assent forms for children in clinical trials are magnified in multilingual and multicultural settings. This is where cultural norms, linguistic diversity, and cognitive differences must be navigated carefully. By using culturally sensitive language, visual aids, localised examples, and empowering children to make voluntary decisions, researchers can enhance the ethical standards and effectiveness of assent processes globally. This is a long way from the pervasive, if not standard, one-size-fits-all approach to patient-facing consent and assent documentation.

Thank you for reading,

Mark Gibson

Leeds, United Kingdom