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 age 18 and is either married or widowed is automatically emancipated. Further, Alabama law now 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.
Investigators who propose research involving persons younger than 18 years of age must provide protocol-specific information about their involvement. The IRB must be able to determine that the proposed research meets the requirements of all applicable federal regulations. Investigators use the Special Population Review Form—Children to provide information that is sufficient for the IRB to confirm that the applicable requirements are met and to describe the research as fitting Children´s Risk Level (CRL) 1, 2, 3, or 4. (These risk levels are described on the form.)
Federal regulations require special protections for "children" in research. The protections are in 45 CFR Part 46 Subpart D and, as applicable, 21 CFR Part 50 Subpart D, and 34 CFR Part 97 Subpart D. However, the criteria that define "children" come from local laws and institutional policy. When research procedures are to be performed in another state, investigators should contact the IRB for guidance on meeting local requirements.
UAB Office of Counsel has defined people younger than 18 as "minors." Usually, minors cannot provide legally effective consent for medical treatment or research procedures. Therefore, the UAB IRB requires that all applicable federal protections for children be incorporated in protocols that allow enrollment of participants younger than 18.
One required federal protection is commonly called "parental consent." It requires that a child-participant's parents or guardian be informed about the research and consent to the child's participation. In practice, it is important to ensure that this consent/permission comes from a person who is legally authorized to give consent for the minor-participant.
- If the proposed research involves no more than minimal risk (CRL 1), or does involve greater than minimal risk but is of possible direct benefit to the child (CRL 2), the consent of both parents is required unless the IRB finds that the permission of one parent is sufficient for the proposed research.
- If the research involves greater than minimal risk without direct individual benefit (CRL 3), permission must be obtained from both parents unless there is only one reasonably available parent. Guardian consent should be substituted for parental under appropriate legal constraints.
- Requires the following when children as wards of the state are involved in research determined to be CRL 3 or CRL 4:
- Appointment of an advocate for each child in addition to any other individual acting on behalf of the child as guardian or in loco parentis (An advocate may serve for more than one child.)
- The advocate to be an individual who has the background and experience to act in, and agrees to act in the best interests of the child for the duration of the child´s participation in the research; and
- The advocate to have no association in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
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.
In two situations the investigator can request that the UAB IRB waive the requirement for parental consent when a potential participant may be younger than 18:
- The UAB IRB does not require parental consent if the potential participant is an "emancipated minor." The Code of Alabama (26-21-2) defines an "emancipated minor" as "a minor who is or has been married or has by court order otherwise been legally freed from the care, custody and control of her [sic] parents." The IRB will base its decision on applicable state law. In this situation, federal requirements for consent and assent still apply to any participants who are younger than 18 and not emancipated. The IRB will review, on a case-by-case basis, studies in which adolescents (14-18 years of age or >12 years of age in the case of STDs) will be participating and in which the investigator requests an exception to parental consent.
- The federal requirement for parental consent recognizes an exception when "parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or abused children)" [45 CFR 46.408(c)]. Investigators who wish to incorporate this waiver must indicate in the Human Subjects Protocol (a) why parental consent is not a reasonable requirement and (b) what protections will be used to protect the child-participants. In this situation, the IRB may request additional information from the investigator to ensure adequate protection of the child-participants.
Aside from requiring parental consent, the federal regulations also require obtaining the child's assent to participate, as determined appropriate by the IRB. Therefore, investigators must propose, in the Human Subjects Protocol (HSP), methods to obtain and document assent that are based on the age, maturity, and psychological state of the children involved. Any request to waive the assent requirement must be described in the HSP. The IRB generally recommends the following methods by age (in years):
- Younger than 7: Obtaining assent may be appropriate, depending upon the participant population. If assent is to be obtained, a written assent document may also be appropriate.
- 7 and older but younger than 14: Assent must be obtained unless this requirement is waived by the IRB. An assent document should be used, written simply and at a comprehension level appropriate for a 7-year-old child. An assent section on the adult consent document may be appropriate for research that involves only adolescents (e.g., 13- and 14-year-olds).
- 14 and older but younger than 18: Assent must be obtained unless this requirement is waived by the IRB. An assent section on the adult consent document may be appropriate, or a separate assent form may be prepared in the same language as the adult consent document.
US Department of Education Funded Research
When research is funded by the US Department of Education access to instructional material (including teachers´ manuals, films, tapes, or other supplementary instructional material) used in connection with the research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in the research.
Research or experimentation program or project is defined as any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.
Children are defined as persons enrolled in the research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law which in Alabama is 18 years of age.