Definitions: Children

Child: “Persons who have not attained the legal age for consent to treatments or procedures involved in the research [clinical investigations], under the applicable law of the jurisdiction in which the research [clinical investigation] will be conducted.” 21 CFR 50.3(o), 45 CFR 46.402(a) [FDA]

HRPP Manual Section 6-8-C, Special Categories of Research Subjects: Children:

In Michigan, a child is a person who has not:

1.     Yet reached the age of 18; and

2.     Been emancipated by court order; and

3. Been emancipated by operation of law under any of the following circumstances:

a.     Marriage

b.     Active duty with the armed forces of the United States

Michigan law states that an emancipated minor has the rights and responsibilities of an adult (with certain exceptions), including the right to authorize his or her own preventive healthcare. Although it is a reasonable inference, Michigan law does not explicitly state that emancipated minors may consent to participation in research. Thus, the IRB, with input from the MSU Office of the General Counsel, may choose not to approve research that relies solely on the consent of an emancipated minor.

Emancipated: A legal status conferred upon persons who have reached the age of 18 or who have not yet attained the legal age of competence as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had, by virtue of assuming adult responsibilities, such as marriage or serving on active duty in the military, or by virtue of a court order.