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Institutional Review Board - Appendix I Sample Assent Form - ashford

Institutional Review Board - Appendix I Sample Assent Form - ashford 2025

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The document provides a template for an assent form required for research studies involving minor children. It outlines the necessary steps to inform children about the study in age-appropriate language, ensuring they understand their participation is voluntary and contingent upon parental consent. Key elements include introducing the study, describing tasks, risks, benefits, encouraging discussion with parents, inviting questions, and emphasizing the child's right to withdraw at any time.

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How can assent be given?

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.

What is an example of assent?

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).

How to write an IRB consent form?

The Consent Form used in a study should be edited to match requirements of the specific study: It should include information about the investigator, the topic under study, and a clear description of purpose, risks, and benefits.

How do I document assent?

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.

How to do 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.