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Research Participant Confidentiality Agreement
"I need a Research Participant Confidentiality Agreement for a medical technology study starting in March 2025, which will involve collecting biometric data from participants across multiple research sites in the Netherlands, with specific provisions for data sharing with our US-based parent company."
1. Parties: Identification of the research institution/researcher and the research participant
2. Background: Context of the research project and purpose of the agreement
3. Definitions: Definitions of key terms including 'Confidential Information', 'Research Project', 'Personal Data', and 'Research Data'
4. Scope of Participation: Details of what the research participation involves
5. Confidentiality Obligations: Core confidentiality obligations of the participant regarding research information
6. Data Protection: GDPR-compliant provisions regarding handling of personal data
7. Duration and Survival: Term of the agreement and which provisions survive termination
8. Return of Confidential Information: Obligations regarding return or destruction of confidential information
9. General Provisions: Standard provisions including governing law, jurisdiction, and entire agreement
10. Signature Page: Execution blocks for all parties
1. Intellectual Property Rights: Required when research may generate IP or when participants need to assign rights to any contributions
2. Publication Rights: Needed when there's possibility of research publication and participants need to be informed about use of data
3. Compensation: Include when participants receive payment or reimbursement for participation
4. Medical Information Handling: Required when research involves medical data or falls under WMO regulations
5. Third Party Disclosure: Include when there's potential need to share information with specific third parties
6. Withdrawal Rights: Detailed section on withdrawal rights when research falls under specific regulatory frameworks
1. Research Project Description: Detailed description of the research project and participant's role
2. Data Processing Details: Specific details about what personal data will be collected and how it will be processed
3. Consent Form: Separate detailed consent form complying with GDPR and research ethics requirements
4. Privacy Notice: Detailed privacy notice as required by GDPR
5. Security Measures: Description of technical and organizational measures for protecting confidential information
Authors
Healthcare
Academic Research
Pharmaceutical
Technology
Social Sciences
Psychology
Market Research
Clinical Trials
Biotechnology
Environmental Science
Education
Consumer Research
Legal
Research & Development
Clinical Operations
Data Protection
Research Ethics
Regulatory Compliance
Academic Affairs
Research Administration
Human Resources
Information Security
Research Director
Principal Investigator
Research Coordinator
Ethics Committee Member
Data Protection Officer
Research Administrator
Legal Counsel
Research Ethics Officer
Clinical Trial Manager
Research Project Manager
Academic Researcher
Research Compliance Officer
Human Subjects Research Coordinator
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