Participants who are minors (under the age of 18 and not legally emancipated) cannot give their “informed consent”; but they may “assent” to participate in research. Assent is defined as “a child’s affirmative agreement to participate in research”. Passive consent, or allowing a parent/child to “opt out” of a research activity or procedure, is not acceptable.
These Guidelines assume youth who are developmentally and educationally on-track for their chronological age. If necessary, adapt the age cut-offs to fit your specific population and then explain in the Consent section of your protocol why you have chosen a higher or lower level for your age group.
In ordinary minimal risk research, the children in this age group should simply be told verbally what the research activity will be, and the description should be extremely simple and age-appropriate. For instance, “we will give you some stickers and you will tell us which one you like the most,” or “you will tell us a story about something that happened to you and I will take notes.” The child may then be asked if they choose to participate in the activity or not in order to obtain verbal consent.
For this age group, the parental consent should include this statement in the “Risks” section: “If your child indicates through his/her behavior, or any other means, that they do not want to participate in one or any of the research activities, their participation will be stopped immediately.”
If the children are too young to read or write, or are functioning at that level, please don’t submit an assent to be read and signed by them.
The purpose of the assent form for this age group is to inform the youth of what will happen during the research procedures and, out of respect for them as research subjects, ask them to sign a form to indicate their permission. There is no expectation that the youth necessarily comprehend the concept of risk and benefit or altruism.
This should be a written and signed form that is very simple and informative in terms of what will happen. Keep it non-technical, jargon-free and readable by your prospective participants.
Since the adult consent form should be written at no higher than an eighth grade reading level, a 14-year-old should be able to understand the same form and concepts. This assent could be a simplified version of our adult informed consent model, assuming that the adult version is written at the eighth grade level. Again, make it non-technical, jargon-free and readable by the 14-17 year olds who will participate in your research.
Minors this age do not like to be referred to as children, so please refer to them as “youth” or “adolescents” in the assent form.