Definition of Assent: Minor (Child) is a person, who has not attained the legal age of eighteen (18), can assent but cannot legally consent to treatments or procedures involved in research.
Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research does not involve interventions likely to be of benefit to the participants and the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each study whether all or some of the children are capable of assenting to participation. Federal regulations do not require that assent be sought from children starting at a specific age; therefore, determination by the IRB will be made based on such factors as the nature of the research and the age, maturity, status, and psychological state of the child participants. Note that the basic consent elements required under the federal regulations for an adult consent are not required to be included in a child assent.
Assent for children should be written using simple language the child can understand. Generally, the IRB suggests the following types of assent be used based on a child’s reading ability:
Oral Script: A simple oral script can be read to young children that are not proficient at reading but are still capable of giving assent.
Written Assent: A written and signed assent form can be given to older children/minors that are proficient readers and capable of comprehending concepts such as a research study, voluntary participation, benefits and risks, etc.
NOTE: The JCU IRB hesitates to specify an exact age range where an oral script versus a written and signed assent is appropriate. In some instances, assent cannot be obtained (e.g. babies and toddlers) and only parental permission is necessary. Each situation and child is different and therefore the JCU IRB in conjunction with the principal investigator will make the appropriate determination on a case-by-case basis.