The federal regulations (Subpart D of 45 CFR 46, 46.401) provide additional protection for children involved as subjects in research. They require that adequate provisions be made for the assent of the child when the child is capable of providing assent, taking into consideration the age, maturity and psychological state of the child involved. Although there are very formal requirements for the elements that must be present in a consent form, no such requirements exist for assent forms. This means that the investigator can propose assent content that he/she believes will best inform children about the study. The following are general guidelines for creating an assent form for your study.
- For research projects involving children, the IRB requires consent from the parent/legal guardian and, if the children are aged 7 years or older, assent from the children.
- Assent is defined as a child’s affirmative agreement to participate in research. Failure to object is not considered assent.
- The assent document should discuss the study purpose, any discomforts or inconveniences the child may experience if he/she agrees to participate, and that participation is voluntary.
- The length of the assent form should be proportional to the complexity of the study and the age of the participants.
- The use of topic headings may improve readability.