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1. 1. Identification of Parties: Details of the research institution, principal investigator, and participant identification fields
2. 2. Research Background: Brief overview of the research project, its purpose and context
3. 3. Definitions: Clear definitions of key terms used in the consent form
4. 4. Research Participation Details: Detailed explanation of what participation involves, including time commitment and activities
5. 5. Data Collection and Processing: Description of what data will be collected and how it will be processed, in compliance with GDPR
6. 6. Risks and Benefits: Clear explanation of potential risks and benefits of participation
7. 7. Participant Rights: Detailed explanation of participant rights, including right to withdraw and data subject rights under GDPR
8. 8. Confidentiality and Data Protection: Information about how confidentiality will be maintained and data protected
9. 9. Costs and Compensation: Information about any costs or compensation related to participation
10. 10. Contact Information: Contact details for researchers, data protection officer, and ethics committee
11. 11. Declaration of Consent: The actual consent statement and electronic signature mechanism
1. Medical Emergency Procedures: Required for research involving medical interventions or potential health risks
2. Commercial Usage Rights: Needed if research results might be commercialized
3. Audio/Video Recording Consent: Required if the research involves recording participants
4. Future Research Use: Optional section for consent to use data in future research projects
5. International Data Transfer: Required if data will be transferred outside the EU
6. Biological Samples: Required if the research involves collecting biological samples
7. Third-Party Access: Required if other researchers or organizations will have access to the data
1. Appendix A: Detailed Research Protocol: Detailed description of the research methodology and procedures
2. Appendix B: Data Protection Impact Assessment Summary: Summary of DPIA findings relevant to participants
3. Appendix C: Participant Information Sheet: Detailed information about the research in lay terms
4. Appendix D: Privacy Notice: Detailed privacy notice compliant with GDPR Article 13/14
5. Appendix E: Withdrawal Form: Template form for withdrawing from the research
6. Appendix F: Contact Details: Complete list of relevant contact information and resources
Healthcare
Academic Research
Pharmaceutical
Psychology
Social Sciences
Market Research
Clinical Trials
Biotechnology
Educational Research
Technology Research
Consumer Research
Medical Devices
Legal
Research & Development
Clinical Operations
Data Protection
Ethics & Compliance
Information Technology
Research Administration
Quality Assurance
Regulatory Affairs
Information Security
Academic Affairs
Research Director
Principal Investigator
Research Ethics Officer
Data Protection Officer
Research Coordinator
Clinical Trial Manager
Legal Counsel
Research Compliance Officer
Research Administrator
Ethics Committee Member
Research Project Manager
Information Security Officer
Privacy Officer
Research Department Head
Clinical Research Associate
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