Question

An Institutional Review Board (IRB) in the U.S. is reviewing a clinical investigation targeting children ages 3-5 years old with Fragile X syndrome. There is a prospect of direct benefit to the children in the context of the investigation. Based on this information, may the IRB waive the requirements for assent?

a) Yes
b) No

Answer 1

Based on the information provided, the IRB may not be able to waive the requirements for assent. Assent is crucial when involving children in research, especially if there is a prospect of direct benefit.

Step-by-step explanation:

Based on the information provided, the Institutional Review Board (IRB) may not be able to waive the requirements for assent in this case. IRBs are responsible for ensuring the ethical treatment of research participants, especially when it involves vulnerable populations such as children. Assent is the process of obtaining the child's agreement to participate in the research, in addition to obtaining informed consent from the parent or legal guardian. Since there is a prospect of direct benefit to the children involved in the clinical investigation, it is important to seek assent to ensure their understanding and involvement in the decision-making process.