Final answer:
Assent from children in research is essential regardless of the level of risk or direct benefits, and it is an ethical requirement to obtain their agreement in addition to parental consent for participation in a study.
Step-by-step explanation:
The question pertains to the practices and ethical considerations of an Institutional Review Board (IRB) regarding the use of assent and informed consent when conducting research studies involving children with severe eczema. In accordance with federal regulations and ethical guidelines, assent is a critical aspect of the research process involving minors. While informed consent is given by parents or guardians, assent is an agreement from the child to participate, indicating their willingness to be a part of the study. This is essential regardless of the level of risk or the direct benefits provided by the study. Therefore, the true statement regarding the IRB's determination is that assent is needed even without direct benefits to the children, which corresponds to option (c). The goal of the assent process is to respect young participants and provide them with an age-appropriate understanding of the study, empowering them to make an informed decision about their participation.