The Consent Form For Research is a crucial document required for any research involving human subjects in Saudi Arabia. It serves as a legal and ethical safeguard ensuring that research participants are fully informed about the study they are agreeing to join. The document must comply with Saudi Arabia's specific regulatory framework, including the National Committee of Bioethics Guidelines, the Law of Ethics of Research on Living Creatures, and principles of Islamic Shariah law. This consent form should be used before commencing any research involving human subjects, whether in medical, academic, or social science contexts. It includes detailed information about the research protocol, potential risks and benefits, confidentiality measures, and participant rights, while ensuring compliance with both local and international research ethics standards.
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1. Study Title and Identification: Clear identification of the research study, including protocol number and institution
2. Introduction: Brief overview of the research study and purpose of the consent form
3. Purpose of the Research: Detailed explanation of why the research is being conducted and its objectives
4. Study Procedures: Detailed description of what participation involves, including duration, activities, and requirements
5. Risks and Discomforts: Clear explanation of potential risks, side effects, or discomforts associated with participation
6. Benefits: Description of potential benefits to the participant and/or society
7. Alternatives: Information about alternative procedures or treatments if applicable
8. Confidentiality: Explanation of how personal information will be protected and data handled
9. Costs and Compensation: Information about any costs or compensation associated with participation
10. Voluntary Participation and Withdrawal: Statement that participation is voluntary and can be withdrawn at any time
11. Contact Information: Details of researchers, ethics committee, and who to contact for questions or concerns
12. Declaration of Consent: Formal statement of consent with spaces for signatures
1. Future Use of Data: Include when research data might be used for future studies or shared with other researchers
2. Genetic Testing Information: Required when the research involves genetic testing or DNA analysis
3. Photography/Video Recording Consent: Include when the research involves taking photographs or recording video/audio of participants
4. Commercial Development: Include when research might lead to commercial products or patents
5. Religious/Cultural Considerations: Include specific considerations related to Islamic principles or local cultural norms when relevant
6. Translator Declaration: Include when the consent form needs to be explained in a language other than written language
7. Guardian Consent: Required when participants are minors or lacking capacity to consent
1. Participant Information Sheet: Detailed information about the study in plain language
2. Schedule of Procedures: Detailed timeline and list of all procedures involved in the research
3. Risk Disclosure Form: Detailed explanation of specific risks associated with procedures
4. Privacy Policy: Detailed information about data protection and privacy measures
5. Emergency Contact Form: Form for participant emergency contact information
6. Withdrawal Form: Template form for participants to withdraw from the study
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Research & Development
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Regulatory Affairs
Ethics & Governance
Quality Assurance
Data Protection
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Relevant Roles
Research Director
Principal Investigator
Clinical Research Coordinator
Research Ethics Officer
Legal Compliance Manager
Medical Director
Research Scientist
Clinical Trial Manager
Research Administrator
Data Protection Officer
Quality Assurance Manager
Research Nurse
Study Coordinator
Regulatory Affairs Specialist
Human Subjects Protection Coordinator
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