Children are legally unable to give valid consent, therefore research involving children requires the permission of parents or legally authorized representatives. When children who can read, comprehend, and write are involved in research, written assentof the child should be obtained as well as the written permission of the parent(s). Assent is “an agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.” Nevada law recognizes parents or court appointed guardians as the legal decision-makers for children in most situations. Please see the Children and Minors — Sample Youth Assent Form, for guidance in formulating the structure and language of an assent form.

In Nevada, a child gains majority at age 18 or upon marriage. Pregnancy does not confer majority status. The regulations permit children, with UNLV IRB approval, to consent on their own behalf if the research involves a treatment for which a child’s consent is permissible under applicable law (e.g., use of contraceptives, treatment for venereal disease or drug abuse). If a subject under the age of 18 is declared to be legally emancipated, s/he may consent to participate in research without the permission of a parent or guardian.

The child’s assent is required in all research where the subject has the capacity to comprehend aspects of the study. The assent process assures an element of understanding, cooperation, and a feeling of inclusion on the part of the child and also illustrates the investigator’s respect for the rights and dignity of the child in the context of research. A child’s refusal to object to participate in research should not be construed as assent. Children should be asked whether or not they wish to participate in the research, particularly if the research: 1) does not involve interventions likely to benefit them; and 2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others.

Assent should be sought when, in the judgment of the UNLV IRB, the children are capable of understanding the nature of their participation in the research. The UNLV IRB is obligated to examine the ages, maturity, and psychological state of the children involved in the research (45 CFR 46.408(a)).

Note: At times there may be inconsistency between the permission of the parent and the assent of the child. A rule of thumb is: A “no” from a child overrides a “yes” from the parent, but a “yes” from a child does not override a “no” from a parent. However, if the UNLV IRB determines that the research offers the possibility of a direct benefit that is important to the child’s health or well-being and is available only in the context of research, the assent of the child is not necessary. In such cases a child’s dissent (which should normally be respected) may, at the UNLV IRB’s discretion, be overruled by the child’s parents.

If the child is under the age of 7, only a parental permission form is required. This form should follow all applicable requirements of informed consent.

If the child is 13-17 years of age, a Youth Assent Form is required in addition to a parental permission form. The youth assent form may follow the format provided for adult consent but is required to contain language written at the appropriate educational level of the youngest prospective subject in the youth age range. In some research projects, it may be necessary to utilize two assent forms written to accommodate subjects at either end of the age range. The Youth Assent Form must contain all required elements of informed consent as identified by subheadings for minimal risk or greater studies.

Please review the Children and Minors — Sample Youth Assent Form for additional guidance.

• If the research poses more than minimal risk and no direct benefit to the child, the investigator is required to gain permission from both parents or the child’s guardian in order for the child to participate in the research.
• If the research poses more than minimal risk but may directly benefit the child, only one of the child’s parents or guardian need give permission.
• The investigator is not required to gain permission from both parents, if one of the parents is not reasonably available, deceased, unknown, legally incompetent, or from a parent who does not have legal responsibility for the care and custody of the child. This caveat does not exempt the investigator from obtaining the permission from at least one parent who has legal responsibility for the child.

The UNLV IRBs are required to make additional considerations for the inclusion of children in research who are wards of the state or any other agency or institution. For research that involves more than minimal risk with no prospect of direct benefit to the individual subjects or for research that requires approval of the Secretary of the Department of Health and Human Services (DHHS), the study must either be 1) related to the subject’s status as a ward, or 2) be conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards (45 CFR 46.406-409).

The UNLV IRB is required to appoint an advocate for each child who is a ward. The advocate must agree to act in the best interest of the child and is required to have the background and experience to act in the best interests of the child for the duration of the child’s participation in the research. The advocate must not be associated in any way with the research, the investigator, or the guardian organization. The requirement for an advocate is in addition to gaining permission from any other person acting on behalf of the child as guardian or in loco parentis.

Subpart D of the federal regulations requires the UNLV IRBs to classify research involving children into one of four categories relating to the risks and benefits of the proposed research:

1. Research involving no greater than minimal risk.
2. Research involving greater than minimal risk, but presenting the prospect of direct benefit to individual subjects. Research in this category is approvable by the UNLV IRB, provided: (a) the risk is justified by the anticipated benefit to the subjects; (b) the relationship of risk to benefit is at least as favorable as any alternative approach; and (c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
3. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield important generalizable knowledge about the subject’s disorder or condition.8Research in this category is approvable, by the UNLV IRB, provided: (a) the risk represents a minor increase over minimal risk; (b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and (d) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
4. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. This section provides a mechanism for the approval of research not falling under categories 1-3. The research must be approved by the Secretary of the Department of Health and Human Services (DHHS) if it is to be funded by the DHHS, after consultation with a panel of experts, and the panel must find that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a significant problem affecting the health and welfare of children.

When assessing risk to children and evaluating a research project proposing to involve children, the UNLV IRB will consider the following issues:

• Is the participation of children as research subjects justified in this particular instance?
• If this research question can be addressed initially in adults, has this work been conducted?
• Have results from any adult research indicated that the proposed research would benefit, or at least would not be harmful to children?
• Has every effort been made to ensure that a parent is present when the research intervention is conducted? This will not only comfort the child but will enable the parent to exercise the right to end the child’s participation in the research project at any time. Investigators should note that in some cases (e.g., research into sensitive personal matters, physical examinations of adolescents, research into abuse, etc.), it may not be appropriate to have a parent present. If a parent will not be present during the course of the project, has the investigator clearly stated why in the protocol?
• Are the personnel involved in the research knowledgeable about and sensitive to the physical and psychological needs of the children and their families?
• Have the investigators taken into account the child’s previous experience with illness and medical interventions? Some children may be able to cope with stresses of research better than others as a result of previous experiences with medicine. Younger, less experienced children may be unprepared for participation in medical research.
• How the investigator determined the number of children to be enrolled for the study. Investigators should justify the number of subjects they propose to study. Investigators should always plan to involve the fewest number of children necessary to obtain statistically significant data from which valid conclusions can be drawn.
• Whether the proposed techniques are the least invasive (physically and psychologically) in order to obtain the information for the study.

The UNLV IRB cannot approve research that exposes children as subjects to more than minimal risk and does not satisfy the conditions outlined above. The federal regulations, however, provide a process for seeking approval for such research from the Secretary of the Department of Health and Human Services (DHHS). Please contact the Office of Research Integrity – Human Subjects Research for more information about this process.