Organization Policy on Research Involving Children (Policy No. D403)
April 2008

It is the policy of the Organization to require adherence to federal regulations regarding the additional responsibilities assigned to the IRB under DHHS regulations (45 CFR 46 Subpart D) and FDA regulations (21 CFR 50 Subpart D), as applicable.  These regulations protect children who are the subjects of research.  For the purpose of applying Subpart D of the federal regulations, children are defined 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..

The IRB must review research covered by Subpart D and approve only research that satisfies the conditions of all applicable sections of Subpart D. The IRB must determine that whenever Subpart D applies, consent will be obtained from each child subject’s parents or guardians, in addition to the child’s assent (when applicable). These findings will be documented on a checklist and in the Minutes for the meeting.

Under DHHS regulations “guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care; and under FDA regulations “guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research. For purposes of subpart D of this part, a guardian also means an individual who is authorized to consent on behalf of a child to participate in research. It is Hopkins’ position that the State of Maryland, guardians may grant permission for children to take part in research for children. However, please see the Guidance on Foster Children.

The Organization authorizes the JHM IRBs to approve research applications that indicate foster children may be enrolled. The IRBs and investigators shall follow the procedures developed with the Baltimore City Department of Social Services and General Counsels of JHHS and JHU to determine the type of guardianship order that would be applicable to obtain legally authorized consent for such a child from Baltimore City who may be eligible for enrollment. The procedures provide a template for investigators who wish to enroll a child who is considered in foster care in another jurisdiction in Maryland or another state. The Organization will follow the regulatory criteria found in DHHS 45 CFR 46 Subpart D, section 46.409 “Wards” and in FDA 21 CFR 50 Subpart D, section 50.56 “Wards.” The IRBs are authorized to approve research involving foster children (or wards of the state) that meet the regulatory criteria for involving children in research found at 45 CFR 46.404, 405, and 406; as well as 21 CFR 50.51, 52, and 53. When a JHM IRB determines a project meets the classification of research approvable under 45 CFR 46.406 and/or 21 CFR 50.53, the IRBs are authorized “to appoint an advocate for each child who is a ward, in addition to any other individual or entity acting on behalf of the child as guardian or in loco parentis” as a condition of approval in accord with federal regulations.

Under Maryland law individuals 18 years of age are considered children as defined in Federal regulations, unless one of the exceptions listed below applies. In other words, under Maryland law Subpart D applies to all individuals 18 years of age, unless the one of following exceptions apply:

A) A person under the age of 18 who is married;

B) A person under the age of 18 who is the parent of a child; or

C) A person under the age of 18 who seeks treatment for one of the following conditions (provided that the research is directly related to one of these conditions and involves minimal risk or involves more than minimal risk and offers the prospect of direct benefit to the subject from the specific treatment):

1. Drug abuse;
2. Alcoholism;
3. Mental or emotional disorder (if age 16 or older);
4. Venereal disease;
5. Pregnancy;
6. Contraception other than sterilization;
7. Physical examination and treatment of injuries from an alleged rape or sexual offense;
8. Physical examination to obtain evidence of an alleged rape or sexual offense; or
9. Initial medical screening and physical examination on and after admission of the person into a detention center.

When research is conducted outside of the State of Maryland the IRB will consult with regulatory for a legal determination about which individuals under the local jurisdiction are children and guardians.

Requirements for Assent by Children

“Assent” means agreement – specifically, in this context, a child’s agreement to participate in research. Assent, like consent, is a process that should be documented.

Under 45 CFR 46.408(a), when, in the IRB’s judgment, children are capable of providing assent, the IRB must determine that adequate provisions are made for soliciting their assent. The IRB will additionally determine how assent will be solicited, obtained and documented. In determining whether children are capable of assenting, the IRB takes into account their ages, maturity, and psychological state. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, then the IRB may determine assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the participants are capable of assenting, the IRB still may waive the assent requirement in accord with 45 CFR 46.116.

Documentation of Assent:

Under 45 CFR 46.408(e), when the IRB determines that assent is required it shall also determine whether and how assent must be documented. Assent forms are designed similarly to consent forms and should include the purpose, procedures, risks and benefits of participating in a particular research study. The assent should be written at the age level of the children, with jargon and technical terms explained or removed.   

For children ages seven and under, the IRB may determine written documentation is not required, but that Investigators must verbally explain the study to the child, including its purpose, procedures, and potential risks and benefits (if appropriate, depending on the child’s age, maturity and development). For children ages eight through 17 years, the IRB may require separate written assent from the child, or may allow an affirmative statement in the parental permission document of “ ” to document an assent process was conducted. Depending on the study, its procedures, risk and benefits, the IRB may determine assent for any or all children, a verbal assent process may be conducted and written documentation made in the record that an assent discussion occurred. Assent (written and verbal) should be obtained in the presence of a parent or legal guardian.