Minor Assent & Parental Permission

Introduction

When children or minors (<18 years of age) are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s), in place of the consent of the subjects.

While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent 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.

The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects - whether all or some of the children are capable of assenting to participation. 

Assent Process

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.

Develop Parental Permission & Assent Forms

The Parental Permission Form must contain the same elements as a typical Consent Form, 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

Determining Capability to Assent

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.




Generic Assent Procedure

Obtaining assent is dependent on the cognitive capacity of the child and the nature of the research participant. Thus, the example which follows is just a starting point. Every attempt should be made to obtain at least assent when working with children. The researcher should attempt to obtain a signature if at all possible.

Example:

(Project Title)

1. Hi, [child's name].

2. My name is _____________, and I am trying to learn more about [Description of project in appropriate language].

3. I would like you to [Description of what you would like the child to do; include points listed above for appropriate age range. Try to avoid using words like “help” and “cooperate” which might suggest coercion].

4. Do you want to do this? [If the child does not indicate affirmative agreement, you cannot continue with this child].

5. Do you have any questions before we start? [Clarify if necessary].

6. If you want to stop at any time just tell me.

A signature can be solicited if appropriate.

A witness statement can be added if the extra protection provided by it is desired.