Assent Form for the United States

Assent Form Template for United States

An Assent Form is a legal document used in the United States to obtain agreement from minors or individuals who cannot provide full legal consent. It differs from a consent form in that it's written in simpler language and is designed to ensure the participant understands what they're agreeing to. These forms are particularly important in research, medical procedures, and educational settings, and must comply with federal and state-specific regulations regarding minor participation and documentation requirements.

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What is a Assent Form?

Assent Forms are essential documents in the United States when working with minors or individuals who cannot provide full legal consent. While these individuals may not have the legal capacity to consent, their agreement to participate is ethically important and often legally required. Assent Forms must be written in age-appropriate language and typically accompany a parent/guardian consent form. They are commonly used in research studies, medical procedures, educational programs, and other activities where understanding and voluntary participation are crucial. The document should clearly explain what the participant is agreeing to, any risks or benefits, and their right to withdraw.

What sections should be included in a Assent Form?

1. Purpose of Assent: Clear statement of what the individual is assenting to, written in simple and age-appropriate language

2. Explanation of Procedures/Activities: Simple, age-appropriate description of what will happen and what is expected of the participant

3. Voluntary Nature Statement: Clear statement that participation is voluntary and can be stopped at any time

4. Risks and Benefits: Simple explanation of any potential risks or benefits of participation

5. Signature Block: Space for signature, date, and any witness signatures required

What sections are optional to include in a Assent Form?

1. Confidentiality Statement: Details about how personal information will be protected and used, required when sensitive information is collected

2. Withdrawal Procedures: Explanation of how to withdraw from participation and what happens to collected information upon withdrawal

3. Contact Information: Details for questions or concerns, including names and contact information for responsible parties

What schedules should be included in a Assent Form?

1. Simplified Terms Glossary: Age-appropriate definitions of key terms used in the assent form

2. Visual Aids: Diagrams or illustrations to help explain procedures or activities

3. Parent/Guardian Information Sheet: Additional detailed information for parents or guardians about the activity or study

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

United States

Publisher

Genie AI

Document Type

Consent Form

Cost

Free to use
Industries

COPPA: Children's Online Privacy Protection Act - Required consideration if the assent form involves minors under 13 years of age

E-SIGN Act: Electronic Signatures in Global and National Commerce Act - Federal law governing the use and validity of electronic signatures in assent forms

ADA: Americans with Disabilities Act - Ensures accessibility requirements are met in the form design and implementation

State Age of Consent Laws: Various state-specific regulations determining the legal age at which individuals can provide valid consent or assent

State Electronic Signature Laws: State-specific regulations governing electronic signatures, which may have additional requirements beyond federal E-SIGN Act

State Informed Consent Requirements: State-specific rules about what constitutes valid informed consent and what information must be disclosed

State Privacy Laws: State-specific privacy regulations (e.g., CCPA in California) that may affect data collection and processing

Common Rule: Federal policy for the protection of human subjects in research (45 CFR 46), relevant if the assent form is for research purposes

FDA Regulations: Food and Drug Administration regulations applicable if the assent form is related to medical research or clinical trials

HIPAA: Health Insurance Portability and Accountability Act - Required consideration if the assent form involves medical information

Contract Law Fundamentals: Basic principles including capacity to contract, consideration, and mutual agreement that must be satisfied for valid assent

Plain Language Requirements: Legal requirements and best practices for ensuring the assent form is written in clear, understandable language

Readability Standards: Guidelines for ensuring the assent form is accessible and comprehensible to the intended audience

Unconscionability Doctrine: Legal principle preventing enforcement of contracts that are grossly unfair to one party, must be considered in form drafting

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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