The Experiment Consent Form is a critical document required for any research involving human subjects in Belgium. It must be used before conducting any experimental research, whether in academic, medical, or commercial settings. The document ensures compliance with the Belgian Law on Human Experimentation of 2004, GDPR, and other relevant EU regulations. It serves multiple purposes: protecting participant rights, documenting informed consent, outlining data handling procedures, and providing legal protection for research institutions. The form must be provided to and signed by participants before any research activities begin, and it should be available in all relevant languages for participants. Special versions may be required for vulnerable populations or high-risk research. This document is essential for obtaining ethics committee approval and maintaining legal compliance throughout the research process.
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1. Parties: Identification of the research institution/experimenter and the participant
2. Background: Brief context about the research project and its purpose
3. Definitions: Key terms used throughout the document
4. Experiment Description: Detailed explanation of the experiment procedures and what participation involves
5. Duration and Time Commitment: Expected length of participation and time requirements
6. Risks and Discomforts: Clear description of potential risks or discomforts associated with participation
7. Benefits: Potential benefits to the participant and/or society
8. Compensation: Details of any payment or compensation for participation
9. Data Protection and Privacy: Information about how personal data will be collected, processed, stored, and protected in compliance with GDPR
10. Participant Rights: Description of rights including withdrawal, data access, and complaint procedures
11. Costs: Any costs the participant might incur
12. Emergency Contacts: Contact information for researchers and ethics committee
13. Declaration of Consent: Formal consent statement and signature blocks
1. Medical Emergency Procedures: Required for experiments involving medical procedures or physical risks
2. Audio/Video Recording Consent: Required if the experiment involves recording of participants
3. Future Research Use: Optional section for consent to use data in future research
4. Commercial Applications: Required if research might lead to commercial products
5. Insurance Coverage: Required for medical experiments or those with physical risks
6. Translation Declaration: Required if the form is provided in multiple languages
7. Biological Sample Storage: Required if the experiment involves collecting biological samples
1. Detailed Experiment Protocol: Step-by-step description of experimental procedures
2. Data Processing Information: Detailed information about data handling procedures as required by GDPR
3. Risk Assessment: Detailed assessment of potential risks and mitigation measures
4. Ethics Committee Approval: Copy of ethics committee approval for the experiment
5. Participant Information Sheet: Detailed information about the study in plain language
6. Withdrawal Form: Template form for participants to withdraw from the study
7. Insurance Certificate: Copy of insurance coverage for medical/physical risk experiments
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Principal Investigator
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Ethics Committee Member
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