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1. Study Title and Research Team Information: Full title of the research study, names and contact information of principal investigator and research team members
2. Introduction: Brief overview of the research study and invitation to participate
3. Purpose of the Research: Clear explanation of research objectives and why the study is being conducted
4. Study Procedures: Detailed description of what participation involves, including time commitment and specific activities
5. Risks and Discomforts: Description of potential risks, side effects, or discomforts associated with participation
6. Benefits: Explanation of potential benefits to the participant and/or society
7. Voluntary Participation: Statement that participation is voluntary and participants can withdraw at any time
8. Confidentiality: Information about how data will be collected, stored, protected, and used
9. Compensation: Details about any payment or compensation for participation
10. Contact Information: Who to contact for questions about the research or participants' rights
11. Consent Declaration: Formal statement of consent with signature lines for participant and researcher
1. Audio/Video Recording Consent: Required when research involves recording of participants
2. Future Use of Data: Needed when data might be used for future research projects
3. Commercial Applications: Required when research might lead to commercial products or patents
4. Genetic Testing Information: Necessary for studies involving genetic testing or biospecimens
5. Translation Statement: Required when consent form is translated from original language
6. Substitute Decision Maker Section: Needed for research involving participants who cannot consent for themselves
7. Pregnancy and Reproductive Risks: Required for clinical trials or studies with potential reproductive risks
8. Indigenous Community Approval: Needed for research involving Indigenous communities
1. Schedule A: Detailed Study Procedures: Step-by-step description of study procedures, including diagrams or flowcharts if applicable
2. Schedule B: Privacy and Data Management Plan: Detailed information about data handling, storage, and security measures
3. Schedule C: Withdrawal Procedures: Detailed procedures for withdrawing from the study and handling of collected data
4. Appendix 1: Glossary of Terms: Definitions of technical or scientific terms used in the consent form
5. Appendix 2: Research Ethics Board Approval: Copy of the REB approval letter and contact information
6. Appendix 3: Additional Resources: List of support services or resources available to participants
Research
Principal Investigator
Research Team
Participant
Personal Information
Confidential Information
Research Ethics Board
Consent
Withdrawal
Data
Personal Health Information
Anonymous Data
De-identified Data
Coded Data
Study Procedures
Adverse Event
Risk
Benefit
Compensation
Substitute Decision Maker
Vulnerable Population
Sponsor
Institution
Privacy
Confidentiality
Secondary Use
Data Storage
Data Retention
Research Protocol
Informed Consent
Capacity to Consent
Biospecimen
Control Group
Intervention
Participant Selection
Voluntary Participation
Study Procedures
Duration of Participation
Risks and Discomforts
Benefits
Alternatives to Participation
Confidentiality
Privacy Protection
Data Collection and Use
Data Storage and Retention
Compensation
Costs
Rights of Participants
Withdrawal Rights
Emergency Procedures
Conflict of Interest Disclosure
Commercial Applications
Future Use of Data
Contact Information
Complaint Procedures
Consent Declaration
Authorization
Indigenous Rights and Considerations
Institutional Approval
Translation Certification
Healthcare
Pharmaceutical
Biotechnology
Academic Research
Clinical Research
Social Sciences
Psychology
Education
Public Health
Medical Devices
Environmental Research
Market Research
Research Administration
Legal
Compliance
Ethics
Clinical Operations
Regulatory Affairs
Data Protection
Research Operations
Quality Assurance
Patient Safety
Research Development
Medical Affairs
Research Coordinator
Principal Investigator
Clinical Trial Manager
Research Ethics Officer
Research Compliance Manager
Legal Counsel
Privacy Officer
Research Administrator
Study Director
Research Nurse
Research Assistant
Ethics Committee Member
Regulatory Affairs Specialist
Research Department Head
Data Protection Officer
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