Human Subjects Research
Consent/Assent Process for Minors
Minor children (under age 18) cannot give legally valid informed consent. Consent must be obtained from the legal parents or court-appointed guardian of the child. When the child is old enough to understand what is being asked of them, the child's agreement to participate should be sought.
A child's agreement to participate is called an ‘assent,' and is documented with an ‘assent form.' This is a child-friendly document that outlines the essential information about the research. All children 8 years through 17 years old should be given an opportunity to assent. Most children 8 and over have the cognitive and emotional maturity to understand a research project and to decide whether they want to participate in it. Some children under the age of 8 may also be able to grant and withhold assent, and the IRB asks researchers to be sensitive to the needs of these children on an individual basis.
Researchers should draft a document 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. Whether or not a signed assent form is used, the educational process of obtaining a minor's consent should:
- tell why the study is being conducted;
- describe what will happen and for how long or how often;
- explain if it will hurt and for how long and how often;
- describe any good things that might happen;
- say what the child's other choices are;
- say it's up to the child to participate and that it is okay to say no; and
- ask for questions