Research Participant Confidentiality Agreement

Research Participant Confidentiality Agreement Template for Germany

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Key Requirements PROMPT example:

"I need a Research Participant Confidentiality Agreement for a clinical trial starting in March 2025 at our hospital in Berlin, which will involve collecting sensitive health data from 200 participants; the agreement must be GDPR-compliant and include specific provisions for biomedical sample collection."

Document background

The Research Participant Confidentiality Agreement is essential for any German research institution conducting studies involving human participants. This document is specifically designed to comply with German legal requirements, including the GDPR, BDSG, and relevant research regulations. It should be used whenever participants are engaged in research studies where they may have access to confidential information or where their personal data will be processed. The agreement covers crucial aspects such as data protection, confidentiality obligations, participant rights, and research ethics requirements. It provides legal protection for both the research institution and participants while ensuring transparent communication about data handling and privacy rights. The document is particularly important in academic, medical, and commercial research settings where participant privacy and data protection are paramount concerns.

Suggested Sections

1. Parties: Identification of the research institution/sponsor and the research participant

2. Background: Brief description of the research project and the need for confidentiality

3. Definitions: Definitions of key terms including 'Confidential Information', 'Research Project', 'Personal Data', and 'Research Materials'

4. Scope of Research Participation: Description of the participant's role and involvement in the research

5. Confidentiality Obligations: Detailed obligations regarding the handling and non-disclosure of confidential information

6. Data Protection and Privacy: GDPR-compliant provisions regarding the processing of personal data

7. Duration and Survival: Term of the agreement and survival of confidentiality obligations

8. Return or Destruction of Confidential Information: Obligations regarding the handling of confidential information after participation ends

9. General Provisions: Standard provisions including governing law, jurisdiction, and entire agreement

Optional Sections

1. Compensation: Details of any payment or compensation for participation, used when the research involves participant remuneration

2. Intellectual Property Rights: Provisions regarding ownership of research results and innovations, used when research may generate IP

3. Publication Rights: Terms regarding the publication of research results and participant anonymity, used in academic research

4. Insurance Coverage: Details of research-related insurance, used in medical or high-risk research

5. Third Party Access: Provisions for sharing data with research partners or regulators, used in collaborative research

6. Emergency Procedures: Safety protocols and emergency contacts, used in medical or high-risk research

7. Withdrawal Rights: Detailed procedures for withdrawing from the research, used in longer-term studies

Suggested Schedules

1. Research Project Description: Detailed description of the research project, methodology, and objectives

2. Data Processing Information: Detailed information about personal data processing as required by GDPR Article 13

3. Consent Form: Separate consent form for participation and data processing

4. Contact Information: List of key contacts including researchers, data protection officer, and emergency contacts

5. Confidential Information Categories: Detailed categorization of types of confidential information involved

6. Security Protocols: Specific procedures for handling and storing confidential information

Authors

Alex Denne

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

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Healthcare

Pharmaceutical

Biotechnology

Medical Devices

Academic Research

Social Sciences

Psychology

Market Research

Clinical Research

Educational Research

Technology Research

Consumer Behavior Research

Relevant Teams

Legal

Research Administration

Clinical Operations

Data Protection

Compliance

Ethics Committee

Research Management

Human Resources

Information Security

Quality Assurance

Relevant Roles

Research Director

Principal Investigator

Research Coordinator

Clinical Trial Manager

Data Protection Officer

Research Ethics Officer

Legal Counsel

Research Administrator

Study Nurse

Research Assistant

Compliance Manager

Ethics Committee Member

Research Project Manager

Human Subjects Protection Specialist

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