When children are involved in research the Federal regulations require Investigators to have the child’s agreement to take part in the study. This is known as assent and means that the study has been explained to the child and the child is willing to take part. This 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 seven 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 (Basic Elements of a Consent Form) 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. Please see Basic Elements of a Consent Form to guide the development of the adolescent (ages 15 to 17) consent forms.
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.