Children are persons who have not attained the legal age for consent to treatments or procedures involved in research; in New York state, anyone under the age of 18 is considered a child. There are some exceptions to this, but generally assume your subject population under 18 will be handled as children. When children are involved in a research activity, it is necessary to obtain their assent and the permission of their parents.
Assent is defined as a child’s affirmative agreement to participate in research. This gives a child the opportunity to decide if they want to take part, and to decline if they are not interested. In these cases, an Assent Form is prepared and the procedure is very similar to that of obtaining consent with an adult. The Investigator provides the form to the child and, depending on the child’s reading ability and comprehension, can read it to or with the child. The child is given the opportunity to ask questions and the Investigator takes the opportunity to explain anything that is not clear.
The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. If the research includes a wide range of ages, then multiple assent forms may be appropriate. The assent process should be conducted in a way that the researcher is able to verify that the child’s participation is not influenced by a parent or guardian. This is especially important when substantial incentives are involved.
Assent is separate from getting a parent or guardian’s permission for the child to participate. Generally, IRBs require that the assent of a minor child be sought when the child is 7 years of age or older, unless the child’s decision-making capacity is impaired. For children 7 to 11 years of age, the assent form should be simple enough for the child to understand what he/she is agreeing to do. In general, it should briefly explain in basic terms:
that they are being asked to participate in a research study;
the purpose of the study;
an estimate of how much time is involved in participating;
what will happen to them if they agree to participate (e.g., “answer some questions”);
the foreseeable risks and/or discomfort and any benefits they may experience (immediate risks and/or discomfort and benefits, rather than future or theoretical possibilities);
that they should ask their parents or researcher any questions they have about participating;
that their participation is voluntary (up to them), and that they may stop at any time;
that their father/mother/guardian knows they have been asked to be a part of the study.
For children between the ages of 12 and 14, investigators should use their judgment in deciding which of the required elements of informed consent would be most appropriate for their study population. For adolescents between the ages of 15 and 17, the assent form should closely follow the consent form used for consenting adult participants.
It is very important that the language be appropriate to the subject’s reading level; if the subject population includes a wide range of ages, it may be necessary to use more than one form.
If appropriate, the child should sign the form and a copy should be given to them or their parent/guardian where appropriate.
In addition to obtaining the assent of a child participant, it is necessary to have parental permission. This gives a parent or guardian the opportunity to learn about the study, ask questions, and agree or decline their child’s participation in the research study. Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that the form is written for the parents so it will reference “your child” instead of “you”.
Under certain circumstances, an IRB may waive the requirements for obtaining parental or guardian permission. If the IRB determines that a research activity is designed to study conditions in children for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the parental permission requirements provided that an appropriate mechanism is in place to protect the children, and provided that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting the children would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition.
Sample Minor Assent Document
This sample is intended to help you create an assent document; the text here is a suggestion for how to introduce the required elements of an assent form in a way that is easy for a child to understand. Parts in bold italics should be modified for your specific project. Other parts may need to be modified as well depending on your research methods.
We are doing a research study about purpose in simple language. A research study is a way to learn more about people. If you decide that you want to be part of this study, you will be asked to description, including time involved.
There are some things about this study you should know. These are procedures, things that take a long time, other risks, discomforts, etc.
Not everyone who takes part in this study will benefit. A benefit means that something good happens to you. We think these benefits might be description.
If you do not want to be in this research study, we will tell you what other kinds of treatments there are for you. This statement applies to research projects that offer treatment or intervention.
When we are finished with this study we will write a report about what was learned. This report will not include your name or that you were in the study.
You do not have to be in this study if you do not want to be. If you decide to stop after we begin, that’s okay too. Your parents know about the study too.
If you decide you want to be in this study, please sign your name.