Assent Consent Form - Netherlands

Assent Consent Form for the Netherlands

Assent Consent Form Template for Netherlands

A legally compliant Assent Consent Form designed for use in the Netherlands, adhering to Dutch medical research laws and EU GDPR requirements. This document serves as a formal mechanism to obtain and record informed assent from participants who may have limited capacity to provide full consent, such as minors or vulnerable individuals. The form includes necessary provisions for data protection, voluntary participation acknowledgment, and clear explanation of procedures, while meeting the requirements of the Medical Research Involving Human Subjects Act (WMO) and other relevant Dutch legislation.

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What is a Assent Consent Form?

The Assent Consent Form is a crucial document required under Dutch law when conducting research or medical procedures involving participants who may have limited capacity to provide full informed consent. This document type is specifically designed to comply with the Netherlands' Medical Research Involving Human Subjects Act (WMO), the EU General Data Protection Regulation (GDPR), and other relevant Dutch healthcare and research regulations. The form must be used alongside standard informed consent procedures when working with minors, individuals with cognitive impairments, or other vulnerable populations. It includes simplified explanations of procedures, risks, and rights, while ensuring all necessary legal requirements are met. The document is essential for research institutions, healthcare providers, and organizations conducting studies or treatments requiring participant assent in the Netherlands.

What sections should be included in a Assent Consent Form?

1. Parties: Identification of the participant, legal representative(s) if applicable, and the organization/researcher requesting consent

2. Introduction: Brief, simple explanation of why this form is needed and what it means to give assent

3. Project Information: Clear, age-appropriate description of the research/procedure/treatment for which assent is being sought

4. Voluntary Participation: Statement explaining that participation is voluntary and can be withdrawn at any time

5. Risks and Benefits: Simple explanation of any risks or benefits, written in age-appropriate language

6. Privacy and Confidentiality: Basic explanation of how personal information will be protected and used

7. Contact Information: Names and contact details of responsible persons for questions or concerns

8. Declaration of Assent: The actual assent statement and signature blocks for all required parties

What sections are optional to include in a Assent Consent Form?

1. Medical Emergency Procedures: Required when the research/procedure involves medical interventions or risks requiring emergency protocols

2. Audio/Visual Recording Consent: Include when the project involves recording of the participant

3. Future Research Use: Include when collected data/samples might be used for future research

4. Compensation Information: Required when there is payment or reimbursement involved

5. Translator Declaration: Include when the form needs to be explained through a translator

6. Witness Statement: Required when participant can only give verbal consent or when required by institutional policies

What schedules should be included in a Assent Consent Form?

1. Summary Information Sheet: Simple, pictorial or age-appropriate summary of key information

2. Parent/Guardian Information Sheet: Detailed information for legal representatives

3. Emergency Contact Form: List of emergency contacts and relevant medical information

4. Rights of Participants: Detailed explanation of participant rights in simple language

5. Data Processing Description: Detailed information about how personal data will be processed and protected

6. Withdrawal Form: Template form for withdrawing assent if desired

Authors

Alex Denne

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

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Free to use

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And Informed Consent Form

A Dutch law-compliant informed consent form for medical research or treatment, meeting WMO and GDPR requirements.

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Alex Denne

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