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Research Data Sharing Agreement Template for England and Wales

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Key Requirements PROMPT example:

Research Data Sharing Agreement

"I need a Research Data Sharing Agreement to allow my pharmaceutical company to share clinical trial data with a university research team in Manchester, with strict confidentiality provisions and compliance with GDPR, starting from March 2025."

Document background
A Research Data Sharing Agreement is essential when organizations need to share research data while ensuring compliance with UK data protection laws and research governance requirements. This agreement, governed by English and Welsh law, provides a framework for secure and compliant data sharing, defining the scope of data use, security requirements, and responsibilities of all parties. It is particularly important in collaborative research projects where sensitive or personal data is involved, and where clear guidelines for data handling and protection are required.
Suggested Sections

1. Parties: Identification and details of all parties involved in the agreement

2. Background: Context of the research and purpose of data sharing

3. Definitions: Key terms used throughout the agreement including data protection terminology

4. Data Description: Detailed description of data to be shared, including data types and formats

5. Purpose of Sharing: Specific permitted uses of the shared data and research objectives

6. Data Protection Obligations: Compliance requirements with UK GDPR and Data Protection Act 2018

7. Security Measures: Required technical and organizational measures for data protection

8. Term and Termination: Duration of the agreement and termination provisions

9. Confidentiality: Obligations regarding confidential information and research data

10. Intellectual Property Rights: Rights and restrictions regarding the use of research data

Optional Sections

1. International Transfer Provisions: Required when data will be transferred outside the UK, including appropriate safeguards

2. Ethical Approval Requirements: Specific research ethics requirements and compliance obligations

3. Commercial Terms: Payment and financial arrangements for commercial research partnerships

4. Publication Rights: Terms governing the publication of research results

5. Clinical Trial Provisions: Specific provisions for clinical trial data sharing

Suggested Schedules

1. Schedule 1 - Data Specification: Detailed technical description of shared data including format, fields, and metadata

2. Schedule 2 - Security Requirements: Specific security measures, standards and protocols to be followed

3. Schedule 3 - Processing Activities: Detailed description of data processing activities and purposes

4. Schedule 4 - Standard Contractual Clauses: Standard contractual clauses for international transfers where required

5. Schedule 5 - Key Contacts: Contact details for data protection officers and key personnel

6. Schedule 6 - Data Retention Schedule: Timeframes for data retention and destruction requirements

Authors

Alex Denne

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

Relevant legal definitions



































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Industries

UK GDPR and Data Protection Act 2018: Core data protection legislation in the UK that governs the processing of personal data, including research data. Sets out principles for data processing, rights of data subjects, and obligations of data controllers/processors.

Privacy and Electronic Communications Regulations (PECR): Specific rules for privacy of electronic communications, which may be relevant if research involves electronic data collection or communication methods.

Clinical Trials Regulations: Specific regulations governing clinical trials and medical research, including requirements for data handling and participant protection in medical studies.

Human Tissue Act 2004: Legislation governing the storage, use, and transfer of human tissue samples and associated data in research contexts.

Mental Capacity Act 2005: Legal framework for research involving participants who may lack capacity to consent, including safeguards and requirements for such research.

Copyright, Designs and Patents Act 1988: Primary legislation governing intellectual property rights, relevant for protecting and sharing research outputs and data.

Trade Secrets Regulations 2018: Regulations protecting confidential business information and know-how, which may be relevant to commercially sensitive research data.

Freedom of Information Act 2000: Legislation governing public access to information held by public authorities, which may affect research data sharing by public institutions.

Common Law Duty of Confidentiality: Legal principle requiring maintenance of confidentiality in professional relationships, including research contexts.

NHS Research Governance: Specific requirements and frameworks for conducting and sharing research within or involving the National Health Service.

International Data Transfer Requirements: Rules and mechanisms for transferring research data internationally, including adequacy decisions and Standard Contractual Clauses under UK GDPR.

Information Security Standards: Technical and organizational standards (such as ISO 27001) for ensuring secure handling and transfer of research data.

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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