Children as Participants in Human Subjects Research
In addition to parental permission for all minors (under age 18 years), the childís assent must be secured. Below are the age related guidelines and requirements for assent.
Assent from Children
Children, ages 7 and older, should be given an opportunity to provide assent. That means that they voluntarily agree to be in the research. Generally, verbal assent through the use of a script should be obtained from children 7 - 11 years of age. Written assent using a written document for the children to sign is sought for older children. Children 12 years of age or older must sign assent after the parent or legal guardian has given permission. The assent process should be tailored to the age, maturity, and psychological state of the children involved and should be easy for the children to understand. Therefore, a given research study may make use of multiple documents to obtain assent, for example:
- verbal script (ages 7 -11),
- written assent document (ages 12- 15), and
- a written assent matching the detail of an adult consent document (ages 16 -17).
Assent from children must be obtained unless:
- The research holds out the prospect of direct benefit to the subject and which is available only in the context of the research (for example, new intervention when none is available).
- The subject is incapable, mentally or emotionally, of being reasonably consulted.
- The IRB specifically waives the requirement and documents protocol-specific justification.
At times there may be inconsistency between parent permission and child assent. Usually a "no" from the child overrides a "yes" from a parent, but a child typically cannot decide to be in research over the objections of a parent. Obviously, there are individual exceptions to these guidelines (such as when the use of an experimental treatment for a life threatening disease is being considered). The general idea, however, is that children should not be forced to be research subjects, even when their parents grant permission to it.
The Assent Form
Researchers should try to draft a form that is age-appropriate and study specific, taking into account the typical child's experience and level of understanding, and composing a document that treats the child respectfully and conveys the essential information about the study. The assent form should:
- tell why the research is being conducted;
- describe what will happen and for how long or how often;
- say it's up to the child to participate and that it's okay to say no;
- explain if it will hurt and, if so, for how long and how often;
- say what the child's other choices are;
- describe any good things that might happen;
- say whether there is any compensation for participating; and
- ask for questions.
For younger children, the document should be limited to one page if possible. Illustrations might be helpful, and larger type makes a form easier for young children to read. Studies involving older children or adolescents should include more information and may use more complex language.