Assent Form Template for England and Wales

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Assent Form Template

I need an Assent Form Template for a medical research study involving minors aged 12-16, which will run from March 2025 to December 2025, ensuring compliance with both research ethics and child protection requirements.

Document background

The Assent Form Template is essential in situations where formal agreement is required but full legal consent may not be possible or appropriate. This document, governed by the laws of England and Wales, provides a structured approach to obtaining and documenting agreement from individuals who may have limited capacity to provide full consent. The template includes clear explanations of the proposed activity, risks, and rights, while ensuring compliance with relevant legislation. It's particularly valuable in healthcare, research, and educational settings where documented agreement is crucial but traditional consent forms may not be suitable.

Suggested Sections

1. Identification of Parties: Details of the person giving assent and the organization/individual receiving it

2. Purpose Statement: Clear explanation of what the assent is being given for

3. Declaration of Understanding: Confirmation that the person understands what they're assenting to

4. Rights and Withdrawal: Statement of rights and ability to withdraw assent

5. Signature Block: Space for signatures, dates, and witness details if required

Optional Sections

1. Parental/Guardian Consent: Required when the person giving assent is a minor or lacks capacity

2. Data Processing Details: Required when personal data will be collected or processed

3. Risk Disclosure: Required when the activity carries specific risks

4. Duration and Expiry: Optional timeframe for the validity of the assent

Suggested Schedules

1. Information Sheet: Detailed information about the activity or process being assented to

2. Privacy Notice: Details of how personal data will be handled

3. Supporting Documentation: Any additional forms or information referenced in the main assent form

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

alex.den.21@genieai.co

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Assent Form

A legal template under English and Welsh law used to obtain formal agreement from individuals who may not have full legal capacity to provide consent.

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Authors

Alex Denne

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