Question

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Documentation is required unless waived by an IRB.
Parents must approve written documentation.
Federal regulations do not require the documentation of minors' assent.
To protect minors documentation is always required.

Answer 1

Federal regulations do not require the documentation of minor's assent.

Step-by-step explanation:

According to the federal regulations, documentation of minor's assent is necessary. However, there are requirements for additional protection for children involved in research. The permission from guardian is made necessary when it comes to minor's assent and children should be provided with proper information before they become a part of the research.