The Research Data Sharing Agreement is essential for organizations engaged in collaborative research activities within Canada where valuable research data needs to be shared between parties. This agreement becomes necessary when research institutions, healthcare organizations, or other entities need to exchange data while ensuring compliance with Canadian federal and provincial privacy laws, including PIPEDA, provincial privacy legislation, and the Tri-Council Policy Statement. The document addresses critical aspects such as data protection, confidentiality, intellectual property rights, and specific use limitations. It is particularly important in contexts involving sensitive data, multi-institutional research projects, or when research outcomes may have commercial potential. The agreement should be customized based on the nature of the data, the jurisdictions involved (considering provincial variations in privacy laws), and specific research requirements.
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1. Parties: Identification of all parties to the agreement, including full legal names and addresses
2. Background: Context of the research project, purpose of data sharing, and relationship between the parties
3. Definitions: Clear definitions of key terms used throughout the agreement, including 'Research Data', 'Confidential Information', 'Data Subject', etc.
4. Purpose and Scope: Specific purposes for which the data will be shared and used, including any limitations
5. Data Description: Detailed description of the data to be shared, including format, content, and sensitivity level
6. Terms of Data Transfer: Procedures and timing for data transfer, including technical requirements and security measures
7. Data Protection and Security: Security measures required to protect the data, including storage, access controls, and encryption requirements
8. Confidentiality Obligations: Obligations regarding confidentiality and restrictions on disclosure
9. Permitted Uses and Restrictions: Specific allowed uses of the data and explicit restrictions
10. Privacy Compliance: Requirements for compliance with relevant privacy laws and regulations
11. Intellectual Property Rights: Ownership and IP rights related to the original data and derived works
12. Publication Rights: Terms governing publication of research results and acknowledgment requirements
13. Term and Termination: Duration of the agreement and circumstances for termination
14. Data Retention and Destruction: Requirements for data retention period and secure destruction procedures
15. General Provisions: Standard legal provisions including governing law, dispute resolution, and amendment procedures
1. Commercial Use: Terms governing any potential commercial exploitation of research results, included when commercial applications are anticipated
2. International Transfer: Additional provisions for cross-border data transfers, required when data is shared internationally
3. Third Party Access: Terms governing access by third parties such as subcontractors or collaborators, included when third party involvement is anticipated
4. Cost Recovery: Terms regarding cost sharing or recovery for data preparation and transfer, included when significant costs are involved
5. Insurance Requirements: Specific insurance obligations, included when dealing with high-risk data or activities
6. Ethics Committee Approval: Reference to ethics committee requirements and approvals, included for human subjects research
7. Data Quality Assurance: Provisions regarding data quality standards and verification, included for critical research data
8. Emergency Protocols: Procedures for handling data breaches or emergencies, included for sensitive data sharing
9. Derived Data Rights: Specific provisions regarding rights to data derived from the original dataset, included when derivative works are expected
1. Schedule A - Data Description: Detailed technical description of the data sets, including variables, format, and metadata
2. Schedule B - Security Standards: Specific technical and organizational security measures required
3. Schedule C - Transfer Protocols: Technical specifications for data transfer methods and procedures
4. Schedule D - Authorized Personnel: List of authorized individuals who may access the data
5. Schedule E - Data Management Plan: Detailed plan for handling, storing, and managing the data
6. Schedule F - Privacy Impact Assessment: Assessment of privacy risks and mitigation measures
7. Appendix 1 - Consent Forms: Ƶ or copies of relevant consent forms from data subjects
8. Appendix 2 - Ethics Approvals: Copies of relevant ethics committee approvals
9. Appendix 3 - Data Request Form: Standard form for requesting access to or copies of the data
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