Assent and Parental Permission for the Participation of Children in Research

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.  Generally, when children age 7 or older are involved in research, the IRB requires the assent of the child as well as the written permission of the parent(s).  DHHS 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." California law recognizes parents or court appointed guardians as the legal decision-makers for children in most situations.

In California, a child gains majority at age 18 or upon marriage. Pregnancy does not confer majority status. The regulations permit children, with 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 [45 CFR 46.402(b)]. 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 IRB, the children are capable of understanding the nature of their participation in the research. The IRB is obligated to examine the ages, maturity, and psychological state of the children involved in the research [45 CFR 46.408(a)].

The IRB determination of the assent requirement for a study must be complied with or a minor subject cannot be enrolled.  The Principal Investigator may request an exception for a specific subject.  Before enrolling a minor without assent, prior approval from the Chair or Vice-Chair of the IRB must be obtained.  Approval can be by telephone or e-mail.

NOTE:  If the 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 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.

The IRB is sensitive to parents who, when the child’s health is threatened, may wish to try anything, even when the likelihood of success is marginal and the probability of extreme discomfort for the child is high. When the research involves the provision of experimental therapies for life-threatening diseases such as cancer, difficult decisions must be made when the child does not wish to undertake experimental therapy. In general, if the child is a mature adolescent and death is imminent, the child’s wishes should be respected.

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.
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 [§46.404], or greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, [§46.405] permission of one parent is sufficient.  Where research is classified under §46.406 and §46.407 both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Investigators should obtain written permission from the parent/guardian before contacting children for participation in research.

Conditions of Confidentiality for Parental Permission:

The State of California 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. 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 California 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.

Waiver of Parental or Guardian Permission

The 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 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 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.

  • If the research involves procedures for which children of a certain age may consent on their own under state law, the IRB may waive parental consent. In California, 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 California may receive treatment for the prevention and care of pregnancy (except for abortion or sterilization);

  • Where the subject is legally emancipated.

Children under Seven Years of Age

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.

Writing the Assent Form for Children from 7-17 Years of Age

If the child is 7-17 years of age, a child assent form is usually required in addition to the parental permission form. The form should be brief and study specific, with language that is 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 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. 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 assent form should include why the child was chosen to participate, what is going to happen from the child’s point of view, the risks and discomforts to the child, the possible benefit, if any, to the child and a statement that the child has a choice to participate or to stop at any time without consequences.  There should be a date and signature line for the child, and if desired, for the investigator.  To encourage the child's sense of autonomy it is preferable to require only the child's signature.