Assent is recommended for a minor, a person who is between the ages of 7 and 17, who can assent but cannot legally consent to participation in research. Children under the age of 7 are generally not able to provide assent.
Assent is recommended for research participants 18 or older who are intellectually or emotionally impaired and not legally competent to give their informed consent.
- Minor subjects who are able to read and understand the informed consent document (parent’s permission form) may provide assent on that form with a separate signature line.
- Minor subjects (aged 7 or older) who are too young or intellectually immature to read and understand the parent’s permission form should be given the opportunity to provide written assent on a simplified assent form.
- Adult subjects (18 or older) who are not legally competent to give their informed consent should be given the opportunity to provide written assent on a simplified assent form.
What should be included in the assent form?
- Study Title
- Study Purpose- provide a brief explanation of the purpose of the study.
- Procedures- describe what the subject is being asked to do.
- Withdrawal privilege- describe how a subject can stop participation later even if he/she agrees to start.
- Voluntary participation- include a statement that the subject does not have to participate.
- Confidentiality- indicate that the experimenter will not tell anyone (parents, teachers) what the subject says or does in the study.
- Signature lines- include a signature line for the subject and for the investigator. Be sure to include a date line as well.
- Write the form using language that is appropriate for the age level and mental capacity of subjects.