Assent Form Template for Denmark

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Assent Form

I need a Danish-compliant Assent Form for a medical research study starting in March 2025, which will collect sensitive health data from participants and share anonymized results with international research partners.

Document background

The Assent Form serves as a crucial legal instrument in Danish business and regulatory compliance, particularly where explicit consent or agreement is required from individuals. This document type is essential when organizations need to obtain and document formal consent for various purposes, such as data processing, participation in research, medical procedures, or use of services. The form must comply with Danish legal requirements, including the Danish Contract Law (Aftaleloven) and, where applicable, the Danish Data Protection Act. It's designed to ensure transparency, protect individual rights, and provide clear documentation of consent. The document becomes particularly important in contexts where proof of explicit consent is legally required or where organizations need to demonstrate compliance with Danish regulatory requirements.

Suggested Sections

1. Title and Date: Clear identification of the document as an Assent Form and the date of execution

2. Individual's Information: Full name, contact details, and any relevant identification information of the person giving assent

3. Purpose Statement: Clear and concise explanation of what the individual is assenting to

4. Terms of Assent: Detailed description of what the individual is agreeing to, written in clear and simple language

5. Data Processing Information: Information about how any personal data will be collected, processed, and stored in compliance with GDPR

6. Rights and Obligations: Clear statement of the rights retained by the individual and any obligations being undertaken

7. Duration and Withdrawal: Information about how long the assent remains valid and how it can be withdrawn

8. Declaration: Formal statement of assent with space for signature

9. Contact Information: Details of who to contact with questions or concerns

Optional Sections

1. Legal Guardian Information: Required when the assent form involves minors or individuals who cannot legally provide consent themselves

2. Third Party Disclosures: Required when information or rights will be shared with or transferred to third parties

3. Financial Implications: Required when the assent involves any financial obligations or consequences

4. Medical Information: Required for health-related assent forms, including specific health information and related consents

5. Digital Usage Terms: Required when the assent involves digital platforms or online services

6. Translation Declaration: Required when the form is provided in multiple languages

Suggested Schedules

1. Privacy Notice: Detailed information about data processing practices and privacy policies

2. List of Third Parties: If applicable, a comprehensive list of third parties who may have access to information or rights

3. Rights Summary: A summary of key rights and how to exercise them

4. Withdrawal Form: Template form for withdrawing assent if needed

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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Authors

Alex Denne

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