Obtaining Assent/Consent of Children

The IRB Process


The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children.

DEFINITIONS

Assent: A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent.

Children: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.

Emancipated Minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage or procreation. (See also: Mature Minor.)

Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.

Mature Minor: Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. (See also: Emancipated Minor.)

Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.

Permission is not necessary when the research involves the observations of public behavior when the investigator(s) do not participate in the activities being observed.

Given that children have not reached their full intellectual and emotional capacities, involving children in research requires the permission of their parents or legally authorized representatives (unless parents and representatives are designated to be legally incompetent.

While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent/consent to or dissent from participation. Out of respect for children as developing persons, 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 be of benefit to the subjects; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. Thus, adequate provisions should be made for soliciting the assent/consent of the children when, in the judgment of the IRB, the children are capable of providing such assent/consent.

Techniques for Obtaining Assent/Consent

When soliciting assent/consent the child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate.

Consent

Consent must be obtained from a child who have achieved a level of cognitive development sufficient to give informed consent. This is typically children between the ages of 12 to 18. Of course researchers must recognize that some children may be more or less cognitively developed than the average child. Thus, it is the responsibility of the researcher to determine whether assent or consent is most appropriate for the child and the research at hand. Every attempt should be made to obtain consent. The research must ensure the assent letter is understandable by the appropriate age group.

The following regulations must be followed:

  • If a child is cognitively capable of consenting he/she must be given the opportunity.
  • If a child says “stop” you must stop.
  • If a child is capable of consenting he/she should sign a consent form.
  • Parent(s)/guardian(s) must always sign a consent form.
  • If your reviewer determines your project is high risk or deals with sensitive subjects, the consent form must be signed by both parents/guardians unless only one has legal responsibility for, and care of, the child.

The researcher must indicate to the Board how consent will be obtained. Researchers should adapt the generic consent form to fit the project and age range of the participants.

Assent

For projects involving children cognitively capable of giving assent (normally, children 5-12 years old), one must, in addition to obtaining informed consent from the parents and/or guardians, also obtain assent from the children. Of course researchers must recognize that some children may be more or less cognitively developed than the average child. Thus, it is the responsibility of the researcher to determine at what age assent can be ascertained. It is reasonable to assume some children can assent to research before the age of five (depending on the research paradigm). Every attempt should be made to obtain at least assent.

The following regulations must be followed:

  • If a child is cognitively capable of assenting he/she must be given the opportunity.
  • If a child says “stop” you must stop.
  • Parent(s)/guardian(s) must always sign a consent form.
  • If your reviewer determines your project is high risk or deals with sensitive subjects, the consent form must be signed by both parents/guardians unless only one has legal responsibility for, and care of, the child.

The researcher must indicate to the Board how assent will be obtained. There is no strictly prescribed way for obtaining this assent, and the procedure may be adapted to the particular circumstances.

Documentation of Assent

The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child's age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent's assent.

If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place.

Additional information on informed consent is available on the OHRP website http://answers.hhs.gov/ohrp/categories/1566