Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The correct answer is that it is false that FDA regulations do not require the IRB to ensure that assent from children is obtained. According to both FDA regulations and the Common Rule, when conducting research involving children, the Institutional Review Board (IRB) must consider whether children are capable of providing assent, which is a form of agreement that respects their developing autonomy.

Assent is typically sought in addition to parental consent, which means that even if the research is deemed minimal risk or has received full parental consent, the process of obtaining assent from eligible children is still a necessary requirement. This reflects an ethical commitment to involve children in the decision-making process regarding their participation in research to the extent that they are able.

The practice acknowledges that children should be given a voice in matters that affect them, thus reinforcing the importance of their autonomy even at a young age. Failure to obtain assent might not only violate ethical standards but also regulatory ones, emphasizing the IRB's role in safeguarding the rights and welfare of child participants.