Question

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

Parents must approve written documentation.


Documentation is required unless waived by an IRB.


To protect minors documentation is always required.


Federal regulations do not require the documentation of minors' assent.

Answer 1

Letter D is the correct answer.

In order for minors to participate in research, there is no need of documentation of minors' assent. Federal regulations only require voluntariness and informed consent; the subjects have to participate in research by free choice and be adequately educated about the study they are participating in.