What does ICH E6 require regarding the assent of children in clinical trials?

ICH E6 guidelines emphasize the importance of obtaining the assent of children participating in clinical trials. This requirement acknowledges the autonomy of child participants and the importance of involving them in the decision-making process regarding their participation, to the extent that they are capable of understanding the trial. Assent is a way for children to indicate their willingness to participate, while consent is typically obtained from a legally acceptable representative, such as a parent or guardian.

The requirement for assent unless a valid reason exists for waiving it is rooted in ethical considerations to protect the rights and welfare of minors. It highlights the importance of ensuring that children are not only protected but also treated as valued participants in the research process.

In this context, it is essential to recognize that while consent from guardians is critical, the active participation of children in the assent process is equally important in fostering a respectful and ethical research environment. The options that suggest that assent can be ignored or is only necessary for certain age groups do not align with these ethical principles outlined in ICH E6.