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Research Participant Confidentiality Agreement Template for Netherlands

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Key Requirements PROMPT example:

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."

Document background
The Research Participant Confidentiality Agreement is essential for any research project in the Netherlands involving human participants where confidential or personal data is collected or shared. This document is designed to comply with Dutch law, EU GDPR requirements, and the Dutch Code of Conduct for Research Integrity. It becomes necessary when conducting academic, medical, or commercial research involving human subjects, ensuring proper protection of participant data and research information. The agreement covers crucial aspects such as data handling procedures, confidentiality obligations, participant rights, and compliance with Dutch research ethics requirements. It's particularly important for research falling under the Medical Research Involving Human Subjects Act (WMO) or involving sensitive personal data processing.
Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Alex Denne

Head of Growth (Open Source Law) @ ºÚÁÏÊÓÆµ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions



































Clauses






























Relevant Industries

Healthcare

Academic Research

Pharmaceutical

Technology

Social Sciences

Psychology

Market Research

Clinical Trials

Biotechnology

Environmental Science

Education

Consumer Research

Relevant Teams

Legal

Research & Development

Clinical Operations

Data Protection

Research Ethics

Regulatory Compliance

Academic Affairs

Research Administration

Human Resources

Information Security

Relevant Roles

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

Industries







Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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