Characteristics of the Child/Youth Form, Non-Therapeutic Research
The appropriate method for obtaining assent from children and youth will vary depending on the age of the subject.
Federal
regulations require that assent be obtained from children who are 6 years of
age and older. The means of obtaining assent from children and youth, ages 6
through 18, must be appropriate to the age ranges and levels of mental
development of the prospective subject pool. Although the method for obtaining assent will vary depending on
the age of the subject, these are the characteristics that must be considered:
- For
children ages 6-7, a simple oral description of the study should be given to
prospective subjects. The investigator
should ask the child for verbal assent.
The assent procedure may be documented on an assent form by the presence
and signature of a witness.
- For
children/youth ages 8-18 a more complete description of the research should be
given. The investigator should request verbal assent. The assent procedure may be documented on an
assent form by the presence and signature of a witness.
- A parent
or guardian may not be a witness for a child’s verbal assent document.
- The
required elements of the assent form should be arranged sequentially in
numbered sections.
- The
language, written at the age-appropriate level for the child, must be non-threatening
and non-coercive.
- Include
a statement explaining that the child should consult with his/her parents
and/or legal guardian before deciding whether or not to participate in the
study.
- The
investigator must explain that the decision the child/ youth makes to
participate in the study is voluntary.
- State if
the child will (or will not) receive a gift or payment for participating in the
study.
- State
that the information obtained from the study will be confidential, and how
confidentiality will be maintained.
- Children
must also be informed that they can withdraw from participating in the study at
any time.
- Older
children and youth should be told their rights as research subjects, and provided contact
information for the IRB.