Children and Youth

The legal mandate of the OPRS is to protect the rights and welfare of human subjects. This task becomes more difficult when considering children and minors as research subjects. The federal regulations provide for "Additional Protections for Children Involved as Subjects of Research" [ 45 CFR 46 Subpart D].

Assent and Parental Permission for the Participation of Children in Research

• Assent for Children
• Parental Permission
• Conditions of Confidentiality for Parental Permission
• Waiver of Parental or Guardian Permission
• Children Under Seven Years of Age
• Writing the Assent Form for Children From 7-12 Years of Age
• Condition of Confidentiality for Child’s Assent
• Youth Assent Form
• Parental Permission and Research of Minimal Risk
• Parental Permission and Research of More than Minimal Risk

 

Assent for Children

Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives. When children age 7 or above are involved in research, the regulations require the written assent of the child as well as the written permission of the parent(s). OPRR defines "assent" as "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 Sample 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 legally declared to be emancipated, he/she 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. Investigators should remember that a child’s mere refusal to object to participation in research should not be construed as assent. Out of respect for children as developing persons, they 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.

The federal regulations do not specify the age at which the written assent from children is required. 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: The mere absence of an objection by the child should not be construed as assent [45 CFR 46.402(b)]. 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 [45 CFR 46.408(a)].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. 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.

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Parental Permission

Current regulations tend to avoid the term "consent" when one person grants approval for another to enroll in a research. Parents or legal guardians therefore grant "permission" for children to participate in research [45 CFR 46.408]. The "permission" form is in essence a consent document and should follow all applicable requirements for informed consent as outlined in this manual.

Whenever possible, the permission of both parents should be obtained; however, current federal regulations do not require permission from both parents in all research situations. In general, the risk to the child and the prospect of direct benefit for the child as a research subject determine whether single parental/guardian permission may be permitted. If the research involves no greater than minimal risk, permission of only one parent is sufficient [45 CFR 46.404].If the research involves greater than minimal risk, consent of both parents must be obtained unless one parent is deceased, unknown, incompetent, not reasonably available, or when only one parent has the legal responsibility for the care and custody of the child [45 CFR 46.408(b)].Investigators should obtain written permission from the parent prior to contacting children for participation in research.

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The State of Nevada mandates that investigators and their staff report a reasonable suspicion or known abuse or neglect of a child. When research is likely to reveal possible child abuse, such as interviews about personal behavior, child-rearing practices, discipline, or when talking to others about the child or specific familial relationships, or when the research is conducted in the subject’s home, a medical facility, or a doctor’s office, the parental permission form should clearly indicate that the investigator is required to report a reasonable suspicion or known abuse or neglect of a child, for additional requirements regarding the participation of children in research.) The following statement is required for parental permission forms when investigators conduct research with children that requests information regarding sensitive personal or family behavior or is conducted in the subject’s home:

Under Nevada law the privilege of confidentiality does not include information about sexual or physical abuse of a child. If any member of the research team has or is given such information, she or he is required to report it to the authorities. The obligation to report includes alleged or probable abuse as well as known abuse.

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The UNLV IRB may waive parental permission under limited conditions:

• When the consent of parents is not a reasonable requirement because it poses additional risk to the potential subject, or the parents’ interests may not adequately reflect the child’s interests (for example, in research concerning neglected or abused children), the UNLV IRB may waive the requirement for parental or guardian consent. The researcher should propose an alternative mechanism in the application and explain how it will protect the child. The UNLV IRB may require an alternative mechanism for protecting the rights and welfare of the children. The choice of an appropriate alternative mechanism depends on the nature and the purpose of the research, the risk and anticipated benefit to the child, and their age, maturity, status, and condition. for a more detailed explanation of reporting requirements for child abuse, etc.);
• If the research involves procedures for which children of a certain age may consent on their own under state law, the UNLV IRB may waive parental consent. In Nevada, minors over the age of 12 may give legally valid consent to mental health care and to treatment for communicable disease, substance abuse, pregnancy, rape, and sexual assault. Minors of any age in Nevada may receive treatment for the prevention and care of pregnancy (except for abortion or sterilization);
• Where the subject is legally emancipated.

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 as outlined in this manual.

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Writing the Assent Form for Children From 7-12 Years of Age

If the child is 7-12 years of age, a child assent form is required in addition to the parental permission form. The form should be brief and study specific, with subheadings or numerical paragraphs, and contain language that is both appropriate to the child’s maturity and age. The assent form should have a simple format that is easy to read and when possible, limited to one page. The use of larger type, simple schema, and pictures will facilitate the child’s understanding of the text.

The assent form does not replace a thoughtful discussion with the child regarding participation in the research. Many researchers have suggested that the assent process, or discussion with the child is more important than the document. Investigators should remember that the assent process should take into account, in both oral and written communication, the child’s experience and level of understanding. Ultimately, the assent process should illustrate respect for the child and convey the essential information the child requires, in a manner the child can understand, in order to make a decision about participating in the research.

The UNLV IRB understands that the writing of a good assent form is an art and that there is more than one correct approach to creating a document that is easily understood by the child and includes all of the pertinent information. The UNLV IRB recommends that investigators unfamiliar with the language capabilities of the subject population consult with experts prior to developing an assent form. The simplified form should contain the following elements and conclude with an assent statement:

1. Why the child was chosen to participate
2. What is going to take place from the child’s point of view
3. The risks and discomforts to the child
4. The possible benefit to the child
5. Identification of the researcher by name and telephone number in case the child would like to call and ask questions
6. In non-therapeutic research, statement that child has a choice to participate or to withdraw at any time without consequences
7. Statement that child may keep a copy of the assent form
8. Date and signature lines for the researcher and the child indicating assent.

Assent forms and parental permission forms should be written in parallel fashion in order to maintain consistency between certain guaranteed elements of privacy or privilege to parent/teacher/guardian and the child. For example, investigators should not promise in the parental permission form that the parent has the right to review and edit audio/video-tapes of the child if the assent form assures the child that no one besides the researcher will have access to the material.

For research conducted in a child’s school the parental permission form should indicate, if applicable, that the study is conducted with the approval of but not under the auspices of the school. In addition, the assent form and the parental permission form should clearly indicate that the study:

1. is not part of the child’s regular curriculum and therefore the child’s grade is not affected by a decision whether or not to participate; and
2. does not require the participation of the child and that the child need not participate if s/he chooses not to participate.

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Condition of Confidentiality for Child’s Assent:

When research is likely to reveal possible child abuse, such as interviews about family life, discipline, etc., or is conducted in the subject’s home, a medical facility, or a doctor’s office, the State of Nevada mandates that investigators and their staff report a reasonable suspicion or known abuse or neglect of a child. The assent form should clearly indicate that the investigator cannot protect the child’s confidentiality. The following sample is meant to guide investigators in constructing a fair and honest assent form:

We know your answers are personal and we are very careful with any information you give us. We will not tell anyone what you tell us without your permission unless there is something that could be dangerous to you or to someone else. If you tell us that someone is or has been hurting you, we will have to let people know who are responsible for protecting children, so they can make sure that you are safe.

The UNLV IRB acknowledges the sensitivity of some of the preceding wording for the assent form and will consider alternative wording suggested by investigators as long as the limits on maintaining the child’s confidentiality are made clear.

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Youth Assent Form

If the child is 13-18 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 simple 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.   

Click here to view sample youth assent form

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Parental Permission and Research of Minimal Risk:

Parental permission is required in most circumstances for the participation of children in research. Investigators are required to gain parental permission from at least one of the child’s parents or guardians if the research involves only minimal risk.

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1. 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.
2. 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.
3. The investigator is not required to gain permission form 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 HHS Secretary, 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 is required to have 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 who is not 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. Research 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, and the facility in which the research will be conducted, knowledgeable about and sensitive to the physical an psychological needs of the children and their families?
• Have the investigators taken into account the child-subject’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. Biomedical 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.
• Have the investigators clearly defined how the assent of the child-subjects will be obtained?

All personnel working with children should be familiar with State laws requiring reports of suspected child abuse or neglect.

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 DHHS Secretary. Please contact the OPRS for more information about this process.

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