Subpart D of the federal regulations covers minors in research studies. The term minor refers to those under the legal age of consent, which can vary depending on the legal and cultural understanding of a population.
All UVa employees are legally obligated to report child abuse. University Human Resources has developed a web page that defines child abuse and provides information about how to report an incident. All UVa employees should become familiar with this page but it is particularly relevant to researchers who work directly with children. For more information, please see Child Abuse.
Consent is a legal term. In most states in the United States, an individual cannot consent for him or herself until he or she is 18. For international studies, some cultures may accept that an individual may consent for him or herself at an earlier age, or may require parental consent past 18 years. Thus the age in which one can consent to participate in a study is determined by the legal and cultural definition for consent in the jurisdiction of the study. In some situations there may be exceptions; for example a minor who is married may be “emancipated” from parental consent. A minor who is a parent may be able to consent for his or her child but cannot consent for him or herself. If a child does not have a parent or legally authorized representative and is a ward of the state, a state appointed representative can consent for the child.
Consent also requires an adult level of understanding. Often children, particularly young children, are unable to understand the full scope of the decision put before them. It is important that a parent/legally authorized representative be the primary person to give consent in order to act in the child’s best interests. However, don’t underestimate a child’s ability to understand and their capacity to make a decision to participate. Obtaining permission from the child through an assent form or similar process is an important part of the parent/child consent process.
According to the Code of Virginia, "Legally authorized representative" means, in the following specified order of priority:
- the parent or parents having custody of a prospective subject who is a minor,
- the agent appointed under an advance directive, as defined in § 54.1-2982, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research,
- the legal guardian of a prospective subject,
- the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final,
- an adult child of the prospective subject,
- a parent of the prospective subject when the subject is an adult,
- an adult brother or sister of the prospective subject or
- any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject. This person(s) cannot have any association with the agency conducting the human research.
No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative” (32.1-162.16).
Minors are only allowed to participate in a study if the study fits one of the following categories:
- Research is not greater than minimal risk. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
- Research is greater than minimal risk but presents direct benefit to participant. In order for the Board to approve this study, you must demonstrate that the risk is justified by the anticipated benefit to the child and the relation of the anticipated benefit to the risk is at least as favorable to the child as another approach. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
- Research is greater than minimal risk but will yield generalizable knowledge about disorders or conditions affecting the minor. In order for the Board to approve this study, you must demonstrate that the risk is only a minor increase over minimal risk, the procedure could reasonably occur in the child’s normal care (i.e. medical, dental, psychological, social, or education situation), and the information gathered from the study will provide valuable information for the child’s condition or disorder. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
- Research not otherwise approvable but presents opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. In order for the Board to approve this study, you must justify that this study presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
Wards of the State
Children who are wards of the state (or similar institutions or entities) require additional restrictions in order to include them in a study. The children can only be included in the study if the research is related to their status as wards or if the study is conducted in a setting where the majority of the participants are not wards (i.e. school, camps, hospitals, institutions). The IRB is required to appoint an advocate for each child in addition to other individuals acting on behalf of the child. One individual may serve as an advocate for more than one child; this person should have adequate experience to act in this capacity and can have no association with the study, the researchers, and the guardian organization.
Many of the studies involving minors occur in educational settings. There are additional guidelines for working in an education setting and additional consent requirements. Please see Research in an Educational Setting for more information.
Please note that there are additional guidelines for working with abused children. Even if you will not be targeting abused children for your study, we recommend that you review this section for guidance on handling a situation where abuse is discovered. Please see Child Abuse for more information.
Parents should be contacted about the study before you can approach a child about participating in a study. In a general parent/ child consent process, the parent receives a parent version of the consent form, while the child receives an assent form. The parent should sign the consent form first before the child signs the assent form. Each form should be written to the comprehension level of the target audience.
Determining capacity to assent: A child’s capacity to assent can depend on the complexity of the study and the maturity of the child, but as a general rule, the IRB-SBS requires that assent be obtained from all children ages seven and older. For children younger than seven, it is still appropriate to talk to the child about what they will do and to ask permission to go forward.
When are studies exempt and consent is not required: The Board is allowed to exempt minor studies that are deemed normal educational practice, use educational tests, public observations, or incorporate secondary use of existing data. However, all surveys, interviews, and private observations require that minors have parental permission in order to participate.
When can assent and/or consent be waived? If the child’s capacity to understand is so limited, assent can be waived but parental permission is still required. If the procedure provides a direct benefit important to the health or well-being of the child and it cannot be obtained otherwise, the researcher can proceed without assent though parental permission is required. If a protocol meets the requirements to waive documentation of consent or to waive consent, assent can also be waived. In addition, if consent could be a risk to the child (i.e. abused or neglected child), consent can be waived but must be replaced with an adequate procedure to represent the child, including a procedure to obtain assent from the child where appropriate.
What forms should I use? For most studies, you will want to follow the Parent Consent and Minor Assent templates. In some studies, the parent may act as a participant in the study as well as allowing their child to participate. If so, it may be necessary to provide a separate consent form document that more clearly explains what the parent will do as a participant in the study particularly if parent participation is optional; if you decide to use one form to describe the parent and child participation, make sure to use separate sections to describe what the parent will do and what the child will do. Also, if the study requires that you provide additional forms (i.e. materials release forms, debriefing documents), you should provide a parent version as well as a child version.