ASSENT FORM: EXAMPLE 1 2025

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The informed consent and assent process is usually documented with a consent form and an assent form signed by the research participant and/or read to the research participant. In certain cases, documentation of consent may be waived and an information sheet used instead.
Assent means a minors (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.
Describe what the subject will be expected to do. Describe which part of the study is experimental. Describe all procedures using simple terms and explaining any technical/medical terms. Risks or Discomforts of Participating in the Study (Can anything bad happen to me?)
In all cases where assent may be needed a separate assent form must be created and that form must include the same information as the consent form presented to the guardian (although the language may be changed so that the form reads at the appropriate education/ability level of the individual granting assent).
Assent is an agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7-17 or cognitively-impaired person) to participate in research. Please review the Research Guidance Document on Assent for more information about requirements, etc.

People also ask

Sample Child Assent Forms I have been told that my parents (mom or dad) have said its okay (or, have given permission) for me to participate, if I want to, in a project about . I know that I can stop at any time I want to and it will be okay if I want to stop.

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