How does federal regulation define "children"?

Federal regulation defines "children" as persons who have not yet attained the legal age of consent under applicable laws. This definition is significant because it establishes a clear understanding of who is considered a child for the purposes of research and the protections that are required when involving these individuals in research studies.

The legal age of consent can vary by jurisdiction, but it generally revolves around age 18 in many contexts, including research. This definition is crucial when considering the ethical implications and protections needed for participation, as children are considered a vulnerable population that requires additional safeguards to ensure their rights and welfare are respected.

This understanding helps institutional review boards (IRBs) determine the appropriate measures needed to protect children when they are involved in research, such as obtaining parental consent and ensuring that the research methods are appropriate for their age group.