Assent means a minor’s (e.g., child, youth, adolescent under the age of 18) affirmative agreement to participate in research (45 CFR 46.402(b)). To assent, the minor must actively demonstrate a continued willingness to participate in the research, and not just comply with participation directions.
Researchers must judge whether minors are capable of assent, account for the nature and difficulty of the proposed research activity, and contrast the activity against the age, maturity, physical ability, and psychological state of the minor involved. These considerations should be kept in mind when reviewing the proposed assent procedure and content of the information conveyed to the prospective participants in the consent form.
For older youth and adolescents, a written assent form is desirable. Researchers should consider the reading level of their participants when writing the assent form. In some instances, this may require researchers to define scientific jargon in simple terms. It may also require more concise explanations, or the use of pictures to show study activities. The chart below is an example of the differences between general consent language and language used when explaining study procedures in an assent form.
|Consent Language for Adults||Assent Language for Youth|
|This study is being done to determine how student organization skills and study habits affect their grades.||We are trying to learn about how students study.|
|Your participation is voluntary. You can leave the study at any time even if you have not finished. You can stop participating at any time without penalty.||You do not have to be in this study if you do not want to. Nothing bad will happen to you if you say no now or change your mind after starting the study. You just need to tell me if you want to stop being in the study.|
|The primary researcher will keep all written materials locked in a desk drawer in a locked office. All information obtained from your participation in this study will be held strictly confidential and will be disclosed only with your permission or as required by U.S. or State law.||I will keep the information I collect safe and secure. I will not share information that has your name on it with people who are not part of the research team unless required to.|
|You might feel embarrassed to share personal information. You do not have to answer any questions or share anything you do not want to talk about.||You could feel uncomfortable, afraid, lonely, or hurt. It is okay for you to not answer a question.|
|I understand that my participation in this interview is voluntary. I understand I can ask questions about the purposes, procedures, risks and benefits regarding this research study.||I understand what I am being asked to do and I know that if I have any questions, I can ask the researcher at any time.|
For adolescents (typically ages 12 to 17), their capacity to understand information is closer to that of an adult. They have longer attention spans, larger lexicons, and are familiar with the basics of the scientific method. As a result, the assent procedure should include information similar to what would be provided in an informed consent for adults or parental permission, but written in age-appropriate ways. Researchers may provide:
For youth (typically ages 7 to 11), their age and maturity level may limit their ability to fully comprehend the nature of the research activity. If their cognitive abilities allow, they should be consulted about whether they want to participate in the research. In these cases, it may be appropriate to focus on conveying an accurate picture of what the actual experience of participating in research will be like. Researchers may provide:
The IRB presumes that minors ages 7 and older should be given an opportunity to provide assent. Written assent using a physical document is usually sought in these cases.
For children (typically ages 3 to 6), specific considerations should be made to ensure that they understand what is asked of them. For example, preschool children may need visual representations (e.g., smile, frown, etc.) to help interpret their willingness to engage or continue with a study activity.
For toddlers (typically ages 8 months to 3 years), a researcher may engage directly with the child. However, the child may be unwilling (or unable) to follow directions in a logical or linear way. Researchers should consider study activities that may not follow a set order, but that can respond in flexible ways to the needs of the child. Researchers should account for breaks or playtime as the child may not sit still to complete one task from beginning-to-end.
For infants, researchers may need to defer to the parent or guardian regarding the infant’s typical behavior in order to gauge a child’s comfort level with a study activity. Researchers may need to take into account the likelihood that an infant (or toddler) will get fussy or hungry during a study. Researchers should consider flexible schedules when planning a study activity, and allow for breaks, feeding, or playtime.
The assent procedure should reflect a reasonable effort to enable the child (youth or adolescent) to understand, to the degree they are capable, what their participation in research would involve. Assenting also involves researchers actively observing verbal and non-verbal cues that the youth does not want to participate (e.g., crying, fussing, throwing a tantrum, hesitation, distraction, or discomfort etc.). Researchers should pause (or stop) the study if they observe any signs of resistance the youth may express.
Researchers are asked to check in with young study participants to ensure that they want to continue with the study activity, if they want a break, or if they want to stop entirely. This check-in process may occur at several points during the study. Young study participants must be allowed to break or stop activities at any point. Teachers College IRB will make the final determination on whether a minor in a research study has the capacity to assent.
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