The correct answer is D) Federal regulations do not require the documentation of minors' assent.
The other options of the question were A) Parents must approve written documentation. B) Documentation is required unless waived by an IRB. C) To protect minors documentation is always required.
The statement that most accurately describes the requirement for the documentation of minors' assent to participate in research is "Federal regulations do not require the documentation of minors' assent."
However, as they are minors, the institution is recommended to have the written permission of the parents, describing exactly the methods, procedures, goals, and activities of the research. This way, parents will know everything they need to know about children's participation and if there is a risk involved. This document serves the institution in the extreme case there would be claims or legal problems.
