The Experiment Consent Form is a crucial legal document required under Dutch law for any research involving human subjects. It serves as both an informational tool and a legal record of informed consent, essential for compliance with the Medical Research Involving Human Subjects Act (WMO), GDPR, and research ethics guidelines in the Netherlands. This document should be used whenever conducting research experiments involving human participants, whether in medical, behavioral, social, or technical research contexts. The form includes comprehensive information about the study, potential risks and benefits, data handling procedures, participant rights, and withdrawal options. An Experiment Consent Form must be obtained before any research activities commence and should be updated if significant changes occur during the study. The document provides legal protection for both the research institution and the participants while ensuring ethical research practices.
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1. Study Information: Title of the study, reference number, and organizing institution details
2. Researcher Information: Names and contact details of principal investigator and research team
3. Purpose of the Study: Clear explanation of research objectives and importance
4. Study Procedures: Detailed description of what participation involves, including duration and activities
5. Risks and Discomfort: Clear outline of potential risks, side effects, or discomfort
6. Benefits: Description of direct and indirect benefits of participation
7. Voluntary Participation: Statement emphasizing voluntary nature and right to withdraw
8. Confidentiality and Data Protection: GDPR-compliant explanation of data handling, storage, and protection measures
9. Costs and Compensation: Information about any payments, reimbursements, or costs involved
10. Contact Information: Details for questions, complaints, and emergency situations
11. Declaration of Consent: Formal consent statement and signature blocks for participant and researcher
1. Medical Background Questions: For studies requiring health information - includes relevant medical history questions
2. Audio/Video Recording Consent: When the experiment involves recording of participants
3. Future Research Use: When collected data might be used in future research projects
4. Genetic Testing Information: For studies involving genetic analysis
5. Proxy Consent: When participants are unable to provide consent themselves (minors, impaired capacity)
6. Commercial Applications: When research might lead to commercial products or patents
7. Insurance Information: For medical trials requiring specific insurance coverage
1. Detailed Study Protocol: Step-by-step description of experimental procedures
2. Participant Information Sheet: Detailed information about the study in lay language
3. Data Processing Agreement: GDPR-compliant details of data processing activities
4. Risk Assessment: Comprehensive overview of potential risks and mitigation measures
5. Withdrawal Form: Template for participants to withdraw from the study
6. Emergency Contact Form: Template for emergency contact information
7. Privacy Notice: Detailed information about data protection and privacy measures
Relevant legal definitions
Study
Researcher
Principal Investigator
Research Institution
Participant
Personal Data
Special Category Personal Data
Data Processing
Informed Consent
Research Protocol
Ethics Committee
Medical Research Ethics Committee (METC)
Withdrawal
Adverse Event
Research Records
Confidential Information
Data Controller
Data Processor
Pseudonymization
Legal Representative
Experimental Procedure
Control Group
Medical Device
Study Medication
Research Team
Sponsor
Data Protection Officer
Research Subject
Biological Samples
Secondary Use
Follow-up Period
Side Effects
Scientific Research
Compensation
Emergency Contact
Researcher
Principal Investigator
Research Institution
Participant
Personal Data
Special Category Personal Data
Data Processing
Informed Consent
Research Protocol
Ethics Committee
Medical Research Ethics Committee (METC)
Withdrawal
Adverse Event
Research Records
Confidential Information
Data Controller
Data Processor
Pseudonymization
Legal Representative
Experimental Procedure
Control Group
Medical Device
Study Medication
Research Team
Sponsor
Data Protection Officer
Research Subject
Biological Samples
Secondary Use
Follow-up Period
Side Effects
Scientific Research
Compensation
Emergency Contact
Clauses
Voluntary Participation
Study Procedures
Data Protection
Confidentiality
Risk Disclosure
Benefits
Compensation
Withdrawal Rights
Medical Care
Emergency Procedures
Insurance Coverage
Records Access
Publication Rights
Future Research Use
Sample Storage
Intellectual Property
Liability
Costs
Contact Information
Consent Declaration
Data Subject Rights
Third Party Disclosure
Duration and Termination
Complaints Procedure
Governing Law
Study Procedures
Data Protection
Confidentiality
Risk Disclosure
Benefits
Compensation
Withdrawal Rights
Medical Care
Emergency Procedures
Insurance Coverage
Records Access
Publication Rights
Future Research Use
Sample Storage
Intellectual Property
Liability
Costs
Contact Information
Consent Declaration
Data Subject Rights
Third Party Disclosure
Duration and Termination
Complaints Procedure
Governing Law
Relevant Industries
Healthcare
Academic Research
Pharmaceutical
Psychology
Social Sciences
Medical Devices
Biotechnology
Clinical Research
Educational Research
Technology Research
Consumer Research
Behavioral Sciences
Relevant Teams
Research & Development
Legal
Compliance
Ethics
Data Protection
Clinical Operations
Academic Affairs
Regulatory Affairs
Research Administration
Quality Assurance
Relevant Roles
Research Director
Principal Investigator
Research Coordinator
Ethics Committee Member
Data Protection Officer
Research Ethics Officer
Clinical Trial Manager
Research Compliance Officer
Legal Counsel
Research Administrator
Study Director
Research Scientist
Research Professor
PhD Researcher
Clinical Research Associate
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