UAB Policy on Definition of Child, Parent Guardian
In accordance with its Federalwide Assurance, it is the policy of UAB to require compliance with applicable regulations when conducting or overseeing research involving children. The IRB is responsible for determining whether research involves children and, if so, for ensuring compliance. (See also: PRO108 Procedure for Additional Safeguards for Children Involved in Research.) In the event of a conflict between federal or national, state and/or local law, the most restrictive shall apply.
Federal regulations (21 CFR 50.3, 45 CFR 46.402, 34 CFR 97.402) define children 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 the research will be conducted.” Usually the law of the jurisdiction in which the research is conducted is supplied by state law; under which the legal age for consent is termed the age of majority. Individuals who have not attained the age of majority are termed minors.
The terms “minor” and “child” are not synonymous. Minor refers to individuals who under state law meet the state law definition of “minor.” A “child” is an individual who meets the federal definition of “children” based on state law that defines the legal age to consent to the treatments or procedures. Who is a “child” depends on the jurisdiction in which the research is being conducted and the treatments or procedures being conducted. In many states certain minors have reached the legal age to consent to certain treatments or procedures and therefore are not children under DHHS and FDA regulations. In some states certain adults have not reached the legal age to consent to certain treatments or procedures and are therefore children under DHHS and FDA regulations. Some states have emancipated minor laws that allow minors to consent to certain treatments or procedures as an adult. Other states do not give emancipated minors those rights. Therefore, it cannot be assumed that emancipated minors in all states have reached the legal age to consent to the treatments or procedures involved in research.
Under Alabama law (Ala. Code 26-1-1), a minor is a person younger than 19 years old, unless such a person has been emancipated. A person who is 18 years old and is either married or widowed is automatically emancipated. While Alabama law permits adolescents to consent to “medical” treatment, if they are (1) 14 years of age or older; (2) have graduated from high school; (3) are married or divorced; or (4) are pregnant, there is no statute addressing their capacity to consent to procedures purely for research purposes (i.e., where no “treatment” is involved).
When conducted in Alabama research involving children as defined above will be reviewed in accordance with 45 CFR 46, Subpart D, which generally requires the consent of at least one parent and the assent of the child. The IRB has discretion to consider the ability of adolescents to consent to treatment under state law (see (1)-(4) above for Alabama) as a factor in determining whether to waive parental consent on a case by case basis pursuant to 45 CFR 46.408(c)
Notwithstanding the above, a minor who is the parent of a child who is a prospective participant in research being performed in Alabama may consent to research involving that child or infant (neonate). Also, assent of a child may be waived if the capability of the child is limited by age, maturity, or psychological state.
When research studies are conducted outside the State of Alabama and intend to enroll participants which arguably are children, the investigators and IRB may seek advice from the UAB Office of Counsel on whether the definition of children is met for the applicable jurisdiction.
A parent, for purposes of consent, means either a child’s biological or adoptive parent. In some instances, the consent of a guardian may be used in lieu of parental consent. A guardian is an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. For purposes of research conducted in Alabama a guardian is:
A person acts in loco parentis of a child where the individual voluntarily assumes responsibility for the child’s custody, care, and maintenance even though no court order exists formally appointing the person as the guardian, legal custodian, or adoptive parent of the child.
When research studies are conducted outside the State of Alabama and intend to enroll participants who may have guardians, the investigators and IRB may seek advice from the UAB Office of Counsel on the correct manner to obtain legally effective informed consent for the applicable jurisdiction. The investigator shall ensure that all required consents are obtained before any research involving children as subjects begins.
Approved on March 1, 2010, by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP