The Consent Form For Research is a mandatory legal document required for any research involving human participants in Belgium. It must comply with the Belgian Law of 7 May 2004 on Human Subject Research, GDPR requirements, and the Belgian Law of 30 July 2018 implementing GDPR. This document is essential for establishing informed consent, protecting participant rights, and ensuring ethical research practices. It should be used before commencing any research activities and must include clear information about data processing, participant rights, research procedures, and potential risks and benefits. The form serves both as a legal protection for researchers and institutions and as an informational tool for participants, ensuring transparency and compliance with Belgian and EU research standards.
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1. Study Information: Title of the research study, name of principal investigator(s), and affiliated institution(s)
2. Purpose of the Study: Clear explanation of research objectives and why the study is being conducted
3. Participation Requirements: Detailed description of what participation involves, including time commitment, activities, and procedures
4. Risks and Discomforts: Description of potential risks, discomforts, or inconveniences associated with participation
5. Benefits: Explanation of direct and indirect benefits to participants and society
6. Data Protection and Privacy: GDPR-compliant explanation of how personal data will be collected, processed, stored, and protected
7. Voluntary Participation: Statement emphasizing participation is voluntary and right to withdraw at any time
8. Contact Information: Details for reaching researchers, ethics committee, and data protection officer
9. Declaration of Consent: Formal consent statement and signature section for participant and researcher
1. Compensation: Details about any payment or compensation for participation, used when study offers compensation
2. Medical Emergency Procedures: Information about emergency protocols and insurance coverage, required for medical/clinical research
3. Future Use of Data: Information about potential future use of collected data or samples, needed when data might be used beyond current study
4. Audio/Video Recording Consent: Specific consent for recording procedures, included when study involves recordings
5. Biological Samples: Information about collection, storage, and use of biological samples, required for studies collecting such samples
6. Third Party Data Sharing: Details about sharing data with other researchers or institutions, included when data sharing is planned
1. Detailed Study Protocol: Step-by-step description of research procedures and timeline
2. Data Processing Information: Detailed GDPR-compliant information about data processing activities
3. Participant Rights: Comprehensive list of participant rights under GDPR and research regulations
4. Withdrawal Procedures: Detailed procedures for withdrawing from the study
5. Glossary: Definitions of technical terms used in the consent form
6. Emergency Contact Information: Complete list of emergency contacts and procedures
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Pharmaceutical
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Social Sciences
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Relevant Teams
Legal
Research & Development
Clinical Operations
Regulatory Affairs
Ethics & Compliance
Data Protection
Academic Affairs
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Relevant Roles
Research Director
Principal Investigator
Research Ethics Officer
Data Protection Officer
Clinical Research Coordinator
Research Administrator
Legal Counsel
Compliance Officer
Research Project Manager
Ethics Committee Member
Research Scientist
Clinical Trial Manager
Research Nurse
Research Assistant
Academic Department Head
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