The Informed Assent Form is a crucial document in U.S. research involving minors, required by federal regulations including 45 CFR 46 and 21 CFR 50. This document serves as a tool for explaining research procedures to young participants in age-appropriate language, while acknowledging their developing autonomy. It differs from informed consent in that it seeks the minor's agreement while still requiring parental permission. The form must be approved by Institutional Review Boards (IRBs) and typically includes explanations of procedures, risks, benefits, and the voluntary nature of participation.
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1. Introduction: Age-appropriate explanation of the research study and what the document is for
2. Purpose: Clear, simple explanation of why the research is being conducted
3. Procedures: Step-by-step description of what will happen during the study, written in age-appropriate language
4. Risks and Benefits: Simple explanation of possible risks and benefits of participation
5. Voluntary Participation: Statement that participation is voluntary and can be stopped at any time
6. Confidentiality: Explanation of how private information will be protected
1. Compensation: Details of any payment or reward for participation, if applicable
2. Alternative Procedures: Description of other options available to the participant
3. Future Use of Information: Explanation of how data might be used in future research
4. Audio/Video Recording: Information about any recording that will take place during the study
1. Study Timeline: Visual representation of study events and duration
2. Contact Information Sheet: List of research team contacts and emergency numbers
3. Pictorial Explanations: Age-appropriate illustrations of procedures and equipment
4. Signature Page: Page for participant assent signature, witness signature if required, and date
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