Children and Students

The Code of Federal Regulations consider children to be a particularly vulnerable population, and require that institutional review boards give special consideration to protecting their welfare.

Children are defined by the regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which research will be conducted." [§46.402(a)]

In Massachusetts, persons under the age of 18 are considered children, but this varies state to state and country to country. If using children as subjects outside of the commonwealth of Massachusetts, the investigator must confirm the applicable laws in that state/country. 

When investigators plan on using children as subjects, they must justify their use in detail in Section i ("Justification for Use of Any Special/Vulnerable Subject Populations") of their protocol.