Redesigning Assent Forms in International Clinical Research
Apr 21, 2025
Mark Gibson
,
UK
Health Communication Specialist
Clinical trials are essential for advancing medical knowledge and developing safe and effective treatments. When children participate in clinical research, ethical considerations become even more complex. This is because they are considered a vulnerable population unable to provide legally binding informed consent. To protect their rights and ensure they understand their participation, assent forms are used alongside consent from a caregiver.
Assent forms are designed to obtain a child’s agreement to participate in research. They are meant to be age-appropriate, understandable, and respectful of the child’s developing autonomy. However, significant challenges surround the design, implementation, and ethical implications of assent forms. In international clinical trials, these challenges are compounded by linguistic diversity, cultural differences in communication styles, and varying cultural norms around child autonomy.
This article explores the key issues with assent forms for children in clinical trials. It highlights ethical dilemmas, barriers to comprehension, cultural influences, and practical solutions to enhance understanding and voluntary participation across different languages and cultures.
Complex Language and Cultural Nuances
Assent forms are intended to explain the purpose, procedures, risks, and benefits of a clinical trial in language suitable for a child’s age and cognitive level. However, they are often written using complex language and medical jargon that children find difficult to understand. Terms like "placebo," "randomisation," and "adverse effects" can be confusing, especially when translated into other languages where direct equivalents may not exist.
Complex language and poorly translated terminology lead to misunderstandings about the trial’s purpose and procedures. This compromises informed assent, where a child may not understand what they are signing up to.
Challenges Across Cultures and Languages
Medical terms that are untranslatable and remain in the source language or direct translations of medical jargon can be confusing or misleading. There may not be an equivalent word for “placebo” in some languages. Terms that are specific to clinical studies, even simple ones like “study centre” are often taken for granted that they can be understood. We must never make assumptions about what children – or even lay adults – can and cannot understand.
Cultural differences influence how children interpret information. For example, metaphors or examples used in Western contexts may not be meaningful in non-Western cultures. This is particularly the case where Western idioms have been translated literally (‘the shoe is on the other foot’), which is shockingly common in translated patient-facing documentation. Even more common is the inclusion of health metaphors that compare the body to machinery, comparing the heart to a pump, the lungs to bellows, the brain to a computer, the kidneys to filters, and so on. These are common in Western cultures that do not resonate well elsewhere.
Then, there is language style, where complex sentence structures increase cognitive load. Think of sentences in assent forms that contain nests of clauses, such as the following example that I have rewritten from a real assent form (I only changed the illness):
If you decide to join the study, which is designed to see how the new medicine works in children who, like you, have asthma that doesn’t get better with regular treatments, the doctors, who are trained to make sure everything is safe, will check your health, which includes asking questions about how you feel and doing tests to see how the medicine is working.
While the wording of this is not bad and age-appropriate, the structure of the sentence undoes this decent work. It makes it difficult for children to follow the text.
As clinical research continues to globalise, adopting these best practices is essential to uphold ethical standards and promote equitable participation across diverse cultures and languages. The clinical industry needs to make sure that children everywhere – and their caregivers – fully understand what they are signing up to.
The next article examines the cultural dimension of assent and information overload.
Thank you for reading,
Mark Gibson
Sunderland, United Kingdom
Originally written in
English