Final answer:
Assent is required by both the FDA and ICH guidelines to ensure that human subjects participate in clinical trials with informed understanding. It is an important ethical step in establishing a participant's willingness to be involved in a study, particularly for vulnerable populations.
Step-by-step explanation:
Assent is indeed required for both the FDA (Food and Drug Administration) and ICH (International Conference on Harmonisation). When conducting clinical trials involving human subjects, regulatory frameworks established by these organizations require that participants give informed assent or consent, acknowledging that they understand the nature of the study and agree to partake in the research. The process of assent is particularly important for certain populations, such as children, who are considered unable to provide consent but can still agree to participation in terms that they understand.
For the FDA, assent is part of the requirement for an IND (Investigational New Drug) application, which must be submitted and reviewed before human trials can begin. The ICH guidelines, which harmonize the standards for pharmaceuticals in the EU, Japan, and the United States, also include standards for ethical aspects of clinical trials, implying the necessity of assent or consent from trial participants.
Assent is essential to ensure that human subjects are participating in clinical trials with full knowledge and understanding of the implications, helping to protect their rights and well-being.