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 with applicable law, whether federal or national, state and/or local law. (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 would not be considered children under DHHS and FDA regulations. In some states, however, individuals considered adults in one state have not reached the legal age to consent to certain treatments or procedures in another state,and therefore, would be considered children where research were conducted in the latter state. 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 in all cases.
Further, Alabama law permits a person who is 18 years old and older to consent to participate in IRB approved research conducted by a college or university that is accredited by a federally recognized accrediting agency. Where research is conducted in Alabama outside of the college or university setting, a minor may consent to the research without the consent of one or more parents only if the research involves treatment or procedures for which the minor could consent without the consent of his/her parent(s).
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 (outlined below) as a factor in determining whether to waive parental consent on a case by case basis pursuant to 45 CFR 46.408(c)
Alabama law permits adolescents to consent to general “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. Further, a minor of any age may consent to any legally authorized medical, health or mental health services to determine the presence of, or to treat, pregnancy, venereal disease, drug dependency, alcohol toxicity or any reportable disease.
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 appointed guardian of a child pursuant to the Alabama Uniform Guardianship and Protective Proceedings Act (Code of Alabama, Title 26) as documented by a valid court order;
- A person having legal custody of a child and as documented by court order;
- A person acting in loco parentis, regardless of whether such is documented by a court order.
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.