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1. Study Title and Introduction: Clear identification of the research study and brief overview
2. Purpose of the Research: Explanation of why the research is being conducted and its objectives
3. Procedures: Detailed explanation of what participants will be asked to do during the research
4. Risks and Benefits: Description of potential risks and benefits associated with participation in the study
5. Confidentiality: Information about how participant data will be protected, stored, and used
6. Voluntary Participation: Statement confirming that participation is voluntary and can be withdrawn at any time
7. Contact Information: Contact details for the research team and institutional review board (IRB)
8. Consent Statement: Explicit consent acknowledgment and electronic signature section
1. Compensation: Details about any payment or compensation provided to participants
2. Future Use of Data: Information about potential future use of research data and storage procedures
3. Medical Treatment Available: Information about available medical care for research-related injuries
4. Audio/Video Recording: Specific details about recording procedures and data storage
1. Detailed Study Procedures: Comprehensive step-by-step description of research procedures
2. Privacy Notice: Detailed information about data handling and privacy practices
3. Withdrawal Form: Template form for participants to withdraw from the study
4. Data Sharing Agreement: Detailed information about how data may be shared with other researchers
Research Institution
Investigator
Principal Investigator
Research Participant
Informed Consent
Study Procedures
Personal Data
Confidential Information
Protected Health Information
Data Collection
Data Processing
Data Storage
Research Purpose
Institutional Review Board (IRB)
Voluntary Participation
Withdrawal
Research Team
Study Materials
Compensation
Adverse Event
Electronic Signature
Data Subject Rights
Privacy Notice
Data Retention Period
Research Records
Authorized Personnel
Study Duration
Identifiable Information
De-identified Data
Voluntary Participation
Study Procedures
Duration of Participation
Risks and Discomforts
Benefits
Confidentiality
Data Protection
Data Usage and Storage
Withdrawal Rights
Compensation
Costs
Emergency Contact
Electronic Consent
Rights of Participant
Future Research Use
Recording Authorization
Data Sharing
Publication Rights
Alternative Procedures
Medical Treatment
Injury Compensation
Contact Information
Third Party Access
Termination of Participation
Language Assistance
Conflict Resolution
Governing Law
Amendment Procedures
Acknowledgment and Authorization
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