If the research subject is a minor capable of reading and understanding a simplified version of the consent form used for parents or guardians, the subject is required to sign an assent form. A copy of this assent form must accompany the protocol. For subjects too young to read, but who are capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the protocol. The age, maturity, and psychological state of the subjects must be taken into account by the researcher when creating an assent form or an oral presentation to obtain assent from minors.
From about junior high or middle school onward, a child's written assent is needed (in addition to parental or guardian consent), because children in this age group usually can read and comprehend a well-constructed assent form. The researcher should use supplementary verbal explanations as needed.
Download sample letter to older school child requesting assent (DOC).
For elementary school-age children, the researcher should obtain, in addition to parental or guardian consent, the child's assent to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question/answer setting is often the most useful form of communication. If the child is old enough to provide a signature, student researchers are required to obtain a signed assent.
Download sample assent form appropriate for a younger school child (DOC).
Researchers should give explanations that match the level of understanding for children below school age (infants, toddlers, preschoolers). In many instances, the child's nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure. A verbal script must be submitted as part of the protocol as well as a written consent form to be signed by parents or guardians.
All research participants under the age of 18 must provide written parental (or guardian) consent (DOC) in order to participate in college-sponsored research projects.
A waiver of consent for parental permission could be requested for children 17 years old or younger depending upon the type of research being conducted (ie., the research study is conducted on campus, is a survey or questionnaire, and is determined to be a minimal risk.) The waiver must be requested and justified in the IRB application for each of the following OHRP requirements:
Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met: