Minor Assent & Parental Permission

The assent process, while not legally binding, should involve taking the time to explain to a child, at whatever age they can begin to understand, what is going on in the proposed study, why the study is being done, what will be done to them, and that if they object, the research will be terminated and they will not be punished or scolded. As children develop, they should gradually become the primary guardians of personal health and the primary partners in medical decision-making, assuming responsibility from their parents. Just as is the case with informed consent, the emphasis on obtaining assent should be on the interactive process in which information and values are shared and joint decisions are made.

The Parental Permission Form must contain the same elements as a typical Consent Form (download Consent Form Checklist), be directed to the parent, and be called a Parental Permission Form (and not a Consent Form).

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.

Unless waived by the IRB, child assent and parental permission must be obtained for each participating minor.

Children less than 5 years of age

A simple oral explanation of the study should be offered to the child before study-related procedures are conducted. A signed Parental Permission form is required as well.

Children between the ages of 5 and 12 years

Informed voluntary assent should be obtained without pressure from parents or investigators. The protocol review package should include an example of the explanation to be offered to the child.

Children between the ages of 12 and 16 years

Investigators should submit a permission form for parents and a separate assent form for the child (i.e., at about a 6th grade reading level) to read and sign. An assent form should be written as simply as possible and cover the following points:

• What the study is about
• Why he/she qualifies for the study
• The voluntary nature of the study
• The procedures that will be done
• Potential benefits & potential risks
• An assurance that he/she will be treated the same whether or not he/she agrees to join the study
• An invitation to ask questions
• Assurance that he/she may withdraw from the study after discussing it with his/her parents

Children between the ages of 16 and 18 years

Investigators should submit both Parent Permission and Child Assent forms, written in language that is easily understandable for both the parents and the child (i.e., at 8th grade reading comprehension level), which covers the following points:

• What the study is about
• Why he/she qualifies for the study
• The voluntary nature of the study
• The procedures that will be done
• Potential benefits & potential risks
• An assurance that he/she will be treated the same whether or not he/she agrees to join the study
• An invitation to ask questions
• Assurance that he/she may withdraw from the study after discussing it with his/her parents

Please click on the following link: http://www.hhs.gov/ohrp/researchfaq.html (see Question 18).

In determining whether children are capable of assenting, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research.

Consent

"Consent" involves the act of the will, based upon legal rights of the consenter, which requires the individual to be 18 years of age or older. Individuals who have appropriate decisional capacity and legal empowerment can give their informed consent. Consent embodies judgments about proposed interventions and, more importantly, consent (literally "to feel or sense with") expresses something for one's self: a person who consents responds based on unique personal beliefs, values, and goals.

Minor / Children

"Children" are persons who have not attained the legal age for consent (18 years of age in most states), and thus cannot legally provide "consent" to treatments or procedures involved in research. In some instances, the child may be considered an "emancipated minor" as defined by applicable law in the jurisdiction where the research will be conducted, and may in that case provide legal consent.

Assent

"Assent" means a child's affirmative agreement to participate in research. It is an act signifying understanding (recognizing that the minor has not reached full legal age). Mere failure to object by the child should not, absent affirmative agreement, be construed as assent.

Permission

"Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research. Unless waived, parents must provide their permission (parental consent) to allow their child to participate in the research study. [NOTE: Unless waived, there must be a signed Parental Permission (Consent) form on file for each participating minor. "Passive" consent , i.e., sending the child home with a form which states "please let us know if you don't want your child to participate", and then in the absence of a response (failure to object) from the parent, construing this to mean agreement that the child can participate, is not allowable.]